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National Health Act 1953 - Determinations under sections 85, 85A and 88 - pharmaceutical benefits (No. PB 49 of 2007)

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COMMONWEALTH OF AUSTRALIA
Instrument number PB 49 of 2007
Determinations under sections 85, 85A and 88 of the National Health Act 1953
I, TONY ABBOTT, Minister for Health and Ageing make this instrument under sections 85, 85A, and 88 of the National Health Act 1953.
Dated 24/7/2007
 
 
 
TONY ABBOTT
Minister for Health and Ageing
 
Determinations – pharmaceutical benefits
         
Commencement
1.       This instrument commences on 1 August 2007.
         
Repeal
2.       Instrument number PB 45 of 2007 made on 7 June 2007 with effect from 1 July 2007 is repealed.
         
Definitions
3.       In this instrument:
          “Act” means the National Health Act 1953;
          “base-priced drug” means —
(a)     in relation to ranitidine (tablet, effervescent, 150 mg (as hydrochloride) or syrup 150 mg (as hydrochloride) per 10 mL, 300 mL): cimetidine or famotidine or nizatidine or ranitidine (tablet 150 mg (as hydrochloride) or tablet 300 mg (as hydrochloride)); or
(b)     in relation to lercanidipine or nifedipine (tablet 20 mg (controlled release)): amlodipine, felodipine or nifedipine (tablet 10 mg or tablet 20 mg or tablet 30 mg (controlled release) or tablet 60 mg (controlled release));
          “CFC” means chlorofluorocarbon;
          “CFU” means colony forming unit;
          “electronic communication” has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999;
          “g” means gram;
          “I.M.” means intramuscular;
          “I.U.” means international unit;
          “I.V.” means intravenous;
          “kg” means kilogram;
          “L” means litre;
          “m” means metre;
          “Medicare Australia CEO” means the Chief Executive Officer of Medicare Australia;
          “mg” means milligram;
          “mL” means millilitre;
          “mm” means millimetre;
          “mmol” means millimole;
          “palliative care patient”, in relation to a purpose specified in Part 2 of the Schedule 2, means a patient with an active, progressive, far-advanced disease, and for whom the prognosis is limited and the focus of care is the quality of life;
          “PBS” means Pharmaceutical Benefits Scheme;
          “Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act.
        
Form
4.      For the purposes of subsection 85(3) of the Act, where the strength, type of unit, size of unit or other particulars of form are mentioned in Schedule 1 or, if not mentioned in Schedule 1, in Schedule 2 in relation to a listed drug, these particulars are the form or forms of that listed drug.        
4A.    For the purposes of subsection 85(3) of the Act, a form mentioned in Schedule 4 is a form of a medicinal preparation composed of one or more drugs or medicinal preparations, including a medicinal preparation containing an additive.
 
Manner of administration
5.      For the purposes of subsection 85(5) of the Act, the manner of administration mentioned under the column headed “Manner of administration” in Schedule 1 or, if not mentioned in Schedule 1, in Schedule 2 for a form of a listed drug is the manner of administration for that form of the listed drug. 
         
Brand
5A.    For the purposes of subsection 85(6) of the Act, a brand mentioned in Schedule 1 or, if not mentioned in Schedule 1, in Schedule 2 for a listed drug in a pharmaceutical item, in a form and with a manner of administration mentioned for the listed drug, is the brand of that pharmaceutical item.
   
Participating dental practitioners
5B.    For the purposes of subsection 88(1A) of the Act, the pharmaceutical benefits mentioned in Schedule 3 are the pharmaceutical benefits for the supply of which a participating dental practitioner is authorised to write a prescription.
         
Prescription
6.       For the purposes of subsection 85A(2) of the Act, the quantities and numbers of repeats specified in Part 2 of Schedule 1 or of Schedule 2 for a pharmaceutical item or pharmaceutical benefit are the maximum quantities and number of repeats that a medical practitioner may prescribe or direct on one occasion for the purposes mentioned for the pharmaceutical item or pharmaceutical benefit and no other purposes.
7.       For the purposes of subsection 85A(2) of the Act, the quantities and numbers of repeats specified in Part 2 of Schedule 3 for a pharmaceutical benefit or pharmaceutical item are the maximum quantities and number of repeats that a participating dental practitioner may prescribe or direct on one occasion but only for the purposes mentioned for the pharmaceutical item or pharmaceutical benefit and no other purposes.
8.       For the purposes of subsection 85A(2) of the Act, the manner of administration, if any, mentioned for a pharmaceutical benefit in:                
(a)     Schedule 1 or, if not mentioned in Schedule1, in Schedule 2, is the only manner in which a medical practitioner may, in a prescription, direct the pharmaceutical benefit to be administered; or
(b)     Schedule 3, is the only manner in which a participating dental practitioner may, in a prescription, direct the pharmaceutical benefit to be administered.
9.      For the purposes of subsection 85A(2) of the Act, the maximum quantity or number of units of a pharmaceutical item or  pharmaceutical benefit that may, in one prescription, be directed to be supplied on any one occasion is:                
(a)     where a pharmaceutical item or pharmaceutical benefit is mentioned — 
(i)      in Part 1 of Schedule 1 — the quantity or number, if any, specified in that Part in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or
(ii)     in Part 2 of Schedule 1 and the pharmaceutical item or pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, specified in that Part in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or
(iii)     in Part 1 of Schedule 2 — the quantity or number, if any, specified in that Part in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or
(iv)    in Part 2 of  Schedule 2 and the pharmaceutical item or pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or
(v)     in Part 1 of  Schedule 3 — the quantity or number, if any, specified in that Part in the column headed “Maximum quantity” in relation to the  pharmaceutical item or pharmaceutical benefit; or
(vi)    in Part 2 Schedule 3 and the pharmaceutical item or pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or
(b)     in any other case — the quantity or number, if any, specified in the column headed “Maximum quantity” in Schedule 4 for the form of the pharmaceutical benefit.
10.     For the purposes of subsection 85A(2) of the Act, the maximum number of occasions, if any, on which the supply of a pharmaceutical benefit may, in one prescription, be directed by a medical practitioner to be repeated is:                
(a)     where the pharmaceutical benefit is mentioned — 
(i)      in Part 1 of Schedule 1 — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or
(ii)     in Part 2 of Schedule 1 and the pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or
(iii)     in Part 1 of Schedule 2 — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or
(iv)    in Part 2 of Schedule 2 and the pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or
(b)     in any other case — the number, if any, specified in the column headed “Maximum number of repeats” in Schedule 4 for the form of the pharmaceutical benefit.
11.     The following purposes are specified in relation to each pharmaceutical benefit mentioned in Part 2 of Schedule 1 or 2:
(a)     where a class of persons is specified in the column headed “Purposes” — that the pharmaceutical benefit is to be supplied for the treatment of a person included in that class of persons;
(b)     where a disease or condition is specified in the column headed “Purposes” —
(i)      if subsubparagraph (ii) does not apply — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in relation to any person; or
(ii)     if the disease or condition is specified in relation to a specified class of persons — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in a person included in that class of persons;
(c)     where a purpose is specified in the column headed “Purposes” — that the pharmaceutical benefit is to be supplied for that purpose;
(d)     where it is specified in the column headed “Purposes” that compliance with authority procedures set out in subparagraph 11(d) is required — that a medical practitioner has submitted to the Medicare Australia CEO a prescription for the supply of the pharmaceutical benefit:
(i)      by delivering or posting to the Medicare Australia CEO the prescription prepared and signed by the medical practitioner:
(A)    in a form approved by the Secretary and completed by the medical practitioner in ink in his or her own handwriting; or
(B)     in a form, prepared by means of a computer, that is in accordance with the form approved by the Secretary under subsubsubparagraph (A); or
(C)    in a form, prepared by means of a computer, approved in writing for the purpose by the Secretary and in the format approved in writing by the Secretary; or
(D)    by a method approved in writing by the Secretary; or
(ii)     by submitting the prescription by giving the Medicare Australia CEO by telephone, details of the prescription which has been prepared and signed by the medical practitioner in accordance with subsubparagraph (i); or
(iii)     where the medical practitioner has attempted to obtain an authorisation by submitting details of the prescription to the Medicare Australia CEO in accordance with subsubparagraph (ii) but has been unable to do so because of a failure or other form of unavailability in the telephone system established by the Medicare Australia CEO for the provision of such authorisations, by submitting the prescription in accordance with the instructions stipulated in an emergency telephone message provided to the medical practitioner by the Medicare Australia CEO; or
(iv)    by submitting the prescription by giving the Medicare Australia CEO, by means of an electronic communication of a kind approved in writing by the Medicare Australia CEO, details of the prescription which has been prepared and signed by the medical practitioner in accordance with subsubparagraph (i).
11A.  For the purposes of subparagraph 11(d)(i), a prescription that has been prepared and signed by the medical practitioner in accordance with that subparagraph is taken to have been submitted by him or her if it is submitted by one of his or her employees.
12.     Subject to paragraph 12B, the authorisation of a prescription submitted under subparagraph 11(d) may be made:
(a)     if the prescription was submitted in accordance with subsubparagraph 11(d)(i) — by the Medicare Australia CEO signing his or her authorisation of the prescription on it and:
(i)      if the Medicare Australia CEO requires the medical practitioner to alter the prescription — by returning it to the medical practitioner for alteration before the medical practitioner gives it to the person in respect of whom it was prepared; or
(ii)     in any other case:
(A)    by returning it to the medical practitioner; or
(B)     by sending it to the person in respect of whom it was prepared; or
(b)     if the prescription was submitted in accordance with subsubparagraph 11(d)(ii) — orally, at the time the Medicare Australia CEO is given details of the prescription; or
(c)     if the prescription was submitted in accordance with subsubparagraph 11(d)(iv) — by the Medicare Australia CEO sending his or her authorisation, by electronic communication, to the medical practitioner.
12A.  If the Medicare Australia CEO authorises a prescription in accordance with subparagraph 12(b) or (c):
(a)     the Medicare Australia CEO must tell the medical practitioner, orally or by electronic communication, the number that has been allotted to the authorised prescription; and
(b)     the medical practitioner must:
(i)      mark that number on the prescription; and
(ii)     retain a copy of the prescription for 1 year from the date on which the prescription was authorised.
12B.  Notwithstanding paragraph 12, if the prescription was submitted in accordance with subsubparagraph 11(d)(iii), authorisation shall be deemed to have been granted upon completion by the medical practitioner of the prescription in accordance with the instructions stipulated in the emergency telephone message provided to the medical practitioner by the Medicare Australia CEO.
12BA. If a medical practitioner has written on a prescription, that has been prepared and signed in accordance with subsubparagraph 11(d)(i), the streamlined authority code mentioned in Part 2 of Schedule 1 for a pharmaceutical benefit and purpose:
(a)     subparagraph 11(d) is taken to have been complied with; and
(b)     the Medicare Australia CEO is taken to have authorised the prescription.
12BB. Paragraph 12BA applies to a prescription only if there is a streamlined authority code for the pharmaceutical benefit and purpose in Part 2 of Schedule 1.
12C.  Where a prescription is authorised, or deemed to be authorised, in accordance with paragraph 12, and an authorisation is also granted in accordance with subregulation 13(5) of the Regulations increasing the maximum quantity or number of units of the pharmaceutical benefit that may, in the prescription, be directed to be supplied on any one occasion, or the maximum number of occasions on which the supply of the pharmaceutical benefit may, in the prescription, be directed to be repeated, the authorisation in accordance with paragraph 12 is taken to be for the prescription of the increased quantity, number, or occasions, as the case may be.
13.     The following purposes are specified in relation to a pharmaceutical benefit mentioned in Part 2 of Schedule 3:
(a)     where a class of persons is specified in the column headed “Purposes” — that the pharmaceutical benefit is to be supplied for the treatment of a person included in that class of persons;
(b)     where a disease or condition is specified in the column headed “Purposes” —
(i)      if subsubparagraph (ii) does not apply — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in relation to any person; or
(ii)     if the disease or condition is specified in relation to a specified class of persons — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in a person included in that class of persons;
(c)     where a purpose is specified in the column headed “Purposes” — that the pharmaceutical benefit is to be supplied for that purpose.
 

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Acamprosate
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Campral

Acarbose
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Glucobay 50

 
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Acetazolamide
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Tablet 200 mg-200 mg
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Mylanta P

 
Oral suspension 200 mg-200 mg per 5 mL, 500 mL
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Aluminium Hydroxide with Magnesium Trisilicate and Magnesium Hydroxide
Oral suspension 250 mg-120 mg-120 mg per 5 mL, 500 mL
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2
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Gastrogel

Amantadine
Capsule containing amantadine hydrochloride 100 mg
Oral
100
5
Symmetrel 100

Amiloride
Tablet containing amiloride hydrochloride 5 mg
Oral
100
1
Kaluril

Aminoglutethimide
Tablet 250 mg
Oral
100
5
Cytadren 250

Amiodarone
Tablet containing amiodarone hydrochloride 100 mg
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Aratac 100

 
 
 
 
 
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Amisulpride 200 Winthrop
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60
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Amisulpride 400 Winthrop
Solian 400

 
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Solian Solution

Amitriptyline
Tablet containing amitriptyline hydrochloride 10 mg
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Endep 10

 
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Endep 25

 
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Amlodipine
Tablet 5 mg (as besylate)
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Amlodipine Sandoz
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Amoxycillin
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Amoxil

 
Tablet 1 g (as trihydrate)
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Amoxil Duo
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Augmentin Duo 400
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Amphotericin
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Ampicillin
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Alphacin 500

 
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Injection
28
3
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Aprepitant
Pack containing 1 capsule 125 mg and 2 capsules 80 mg
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30
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Abilify

 
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30
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Abilify

 
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30
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Aspirin
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112
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Astrix
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96
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Solprin

Atenolol
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Tenormin

 
 
 
 
 
Tensig

 
 
 
 
 
Terry White Chemists Atenolol

Atomoxetine
Capsule 10 mg (as hydrochloride)
Oral
56
5
Strattera

 
Capsule 18 mg (as hydrochloride)
Oral
56
5
Strattera

 
Capsule 25 mg (as hydrochloride)
Oral
56
5
Strattera

 
Capsule 40 mg (as hydrochloride)
Oral
56
5
Strattera

 
Capsule 60 mg (as hydrochloride)
Oral
56
5
Strattera

Atorvastatin
Tablet 10 mg (as calcium)
Oral
30
5
Lipitor

 
Tablet 20 mg (as calcium)
Oral
30
5
Lipitor

 
Tablet 40 mg (as calcium)
Oral
30
5
Lipitor

 
Tablet 80 mg (as calcium)
Oral
30
5
Lipitor

Atovaquone
Oral suspension 750 mg per 5 mL, 210 mL
Oral
1
..
Wellvone

Atropine
Injection containing atropine sulfate 600 micrograms in 1 mL
Injection
10
1
AstraZeneca Pty Ltd

 
Eye drops containing atropine sulfate 10 mg per mL, 15 mL
Application to the eye
1
2
Atropt

Auranofin
Tablet 3 mg
Oral
60
5
Ridaura

Aurothiomalate
Injection containing sodium aurothiomalate 10 mg
Injection
10
..
Myocrisin

 
Injection containing sodium aurothiomalate 20 mg
Injection
10
1
Myocrisin

 
Injection containing sodium aurothiomalate 50 mg
Injection
10
1
Myocrisin

Azathioprine
Tablet 25 mg
Oral
100
2
Azahexal
Imuran

 
Tablet 50 mg
Oral
100
2
Azahexal

 
 
 
 
 
Azamun

 
 
 
 
 
Azapin

 
 
 
 
 
GenRx Azathioprine

 
 
 
 
 
Imuran

 
 
 
 
 
Thioprine

Azithromycin
Tablet 500 mg (as dihydrate)
Oral
2
..
Zithromax

 
Powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15 mL
Oral
1
..
Zithromax

Baclofen
Tablet 10 mg
Oral
100
5
Baclo

 
 
 
 
 
Baclohexal

 
 
 
 
 
Chem mart Baclofen

 
 
 
 
 
Clofen 10

 
 
 
 
 
GenRx Baclofen

 
 
 
 
 
Lioresal 10

 
 
 
 
 
Stelax 10

 
 
 
 
 
Terry White Chemists Baclofen

 
Tablet 25 mg
Oral
100
5
Baclo

 
 
 
 
 
Baclohexal

 
 
 
 
 
Chem mart Baclofen

 
 
 
 
 
Clofen 25

 
 
 
 
 
GenRx Baclofen

 
 
 
 
 
Lioresal 25

 
 
 
 
 
Stelax 25

 
 
 
 
 
Terry White Chemists Baclofen

Balsalazide
Capsule containing balsalazide sodium 750 mg
Oral
180
5
Colazide

"BCG Immunotherapeutic" (Bacillus Calmette-Guérin/ Connaught strain)
Single dose set comprising 1 vial powder for intravesical administration containing 6.6 to 19.2 x 108 CFU and 1 vial diluent 3 mL
Intravesical
3
1
ImmuCyst

"BCG-Tice" (Bacillus Calmette-Guérin/ Tice strain)
Vial containing powder for intravesical administration approximately 5 x 108 CFU
Intravesical
3
1
OncoTICE

Beclomethasone
Pressurised inhalation containing beclomethasone dipropionate 50 micrograms per dose, 200 doses (CFC-free formulation)
Inhalation by mouth
1
5
Qvar 50

 
Pressurised inhalation containing beclomethasone dipropionate 100 micrograms per dose, 200 doses (CFC-free formulation)
Inhalation by mouth
1
5
Qvar 100

 
Pressurised inhalation in breath actuated device containing beclomethasone dipropionate 50 micrograms per dose, 200 doses (CFC-free formulation)
Inhalation by mouth
1
5
Qvar 50 Autohaler

 
Pressurised inhalation in breath actuated device containing beclomethasone dipropionate 100 micrograms per dose, 200 doses (CFC-free formulation)
Inhalation by mouth
1
5
Qvar 100 Autohaler

Benzathine Penicillin
Injection 900 mg in 2 mL cartridge-needle unit (for use with Tubex Injector)
Injection
1
..
Bicillin L-A Tubex

 
Powder for injection 900 mg
Injection
1
..
Pan Benzathine Benzylpenicillin

Benzhexol
Tablet containing benzhexol hydrochloride 2 mg
Oral
200
2
Artane

 
Tablet containing benzhexol hydrochloride 5 mg
Oral
200
1
Artane

Benztropine
Tablet containing benztropine mesylate 2 mg
Oral
60
2
Benztrop

 
Injection containing benztropine mesylate 2 mg in 2 mL
Injection
5
..
Cogentin

Benzydamine
Mouth and throat rinse containing benzydamine hydrochloride 22.5 mg per 15 mL, 500 mL
Oral application
1
1
Difflam

Benzylpenicillin
Powder for injection 600 mg (as sodium)
Injection
10
1
BenPen

 
Powder for injection 3 g (as sodium)
Injection
10
..
BenPen

Betamethasone
Injection containing betamethasone acetate 3 mg with betamethasone sodium phosphate 3.9 mg in 1 mL
Injection
5
..
Celestone Chronodose

 
Cream 500 micrograms (as dipropionate) per g, 15 g
Application
1
1
Diprosone
Eleuphrat

 
Cream 200 micrograms (as valerate) per g, 100 g
Application
2
..
Antroquoril

 
 
 
 
 
Betnovate 1/5

 
 
 
 
 
Celestone-M

 
 
 
 
 
Cortival 1/5

 
Ointment 500 micrograms (as dipropionate) per g, 15 g
Application
1
1
Diprosone
Eleuphrat

 
Cream 500 micrograms (as valerate) per g, 15 g
Application
1
1
Betnovate 1/2
Cortival 1/2

 
Ointment 200 micrograms (as valerate) per g, 100 g
Application
2
..
Antroquoril
Celestone-M

 
Ointment 500 micrograms (as valerate) per g, 15 g
Application
1
1
Betnovate 1/2
Cortival 1/2

Betaxolol
Eye drops, suspension, 2.5 mg (as hydrochloride) per mL, 5 mL
Application to the eye
1
5
Betoptic S

 
Eye drops, solution, 5 mg (as hydrochloride) per mL, 5 mL
Application to the eye
1
5
Betoptic
BetoQuin

Bethanechol
Tablet containing bethanechol hydrochloride 10 mg
Oral
100
2
Uro-Carb

Bicalutamide
Tablet 50 mg
Oral
28
5
Cosudex

Bifonazole
Cream 10 mg per g, 15 g
Application
2
3
Mycospor

Bimatoprost
Eye drops 300 micrograms per mL, 3 mL
Application to the eye
1
5
Lumigan

Biperiden
Tablet containing biperiden hydrochloride 2 mg
Oral
200
2
Akineton

Bisacodyl
Tablet 5 mg
Oral
200
2
Bisalax
Lax-Tab

 
Suppositories 10 mg, 10
Rectal
3
5
Durolax
Petrus Bisacodyl Suppositories

 
Suppositories 10 mg, 12
Rectal
3
4
Fleet Laxative Suppositories
Petrus Bisacodyl Suppositories

 
Enemas 10 mg in 5 mL, 25
Rectal
1
2
Bisalax

Bisoprolol
Tablet containing bisoprolol fumarate 2.5 mg
Oral
28
5
Bicor

 
Tablet containing bisoprolol fumarate 5 mg
Oral
28
5
Bicor

 
Tablet containing bisoprolol fumarate 10 mg
Oral
28
5
Bicor

Bivalirudin
Powder for I.V. injection 250 mg (as trifluoroacetate)
Injection
1
..
Angiomax

Bleomycin
Powder for injection containing bleomycin sulfate 15,000 I.U. (with any determined brand of sodium chloride injection as the required solvent)
Injection
10
..
Blenamax
Blenoxane
Mayne Pharma Pty Ltd

Brimonidine
Eye drops containing brimonidine tartrate 2 mg per mL, 5 mL
Application to the eye
1
5
Alphagan
Enidin

Brimonidine with Timolol
Eye drops containing brimonidine tartrate 2 mg with timolol 5 mg (as maleate) per mL, 5 mL
Application to the eye
1
5
Combigan

Brinzolamide
Eye drops 10 mg per mL, 5 mL
Application to the eye
1
5
Azopt
BrinzoQuin

Bromocriptine
Tablet 2.5 mg (as mesylate)
Oral
30
..
Kripton 2.5
Parlodel

 
Capsule 5 mg (as mesylate)
Oral
60
5
Kripton 5
Parlodel

 
Capsule 10 mg (as mesylate)
Oral
100
5
Kripton 10
Parlodel

Budesonide
Nebuliser suspension 500 micrograms in 2 mL single dose units, 30
Inhalation
1
5
Pulmicort Respules

 
Nebuliser suspension 1 mg in 2 mL single dose units, 30
Inhalation
1
5
Pulmicort Respules

 
Powder for oral inhalation in breath actuated device 100 micrograms per dose, 200 doses
Inhalation by mouth
1
5
Pulmicort Turbuhaler

 
Powder for oral inhalation in breath actuated device 200 micrograms per dose, 200 doses
Inhalation by mouth
1
5
Pulmicort Turbuhaler

 
Powder for oral inhalation in breath actuated device 400 micrograms per dose, 200 doses
Inhalation by mouth
1
5
Pulmicort Turbuhaler

Budesonide with Eformoterol
Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses
Inhalation by mouth
1
5
Symbicort Turbuhaler 100/6

 
Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses
Inhalation by mouth
1
5
Symbicort Turbuhaler 200/6

 
Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2
Inhalation by mouth
1
5
Symbicort Turbuhaler 400/12

Buprenorphine
Transdermal patch 5 mg
Transdermal
2
..
Norspan

 
Transdermal patch 10 mg
Transdermal
2
..
Norspan

 
Transdermal patch 20 mg
Transdermal
2
..
Norspan

Bupropion
Tablet containing bupropion hydrochloride 150 mg (sustained release)
Oral
30
..
Bupropion-RL
Clorprax

 
 
 
 
 
Prexaton

 
 
 
 
 
Zyban

Busulfan
Tablet 2 mg
Oral
100
..
Myleran

Cabergoline
Tablet 500 micrograms
Oral
2
..
Dostinex

 
Tablet 1 mg
Oral
30
5
Cabaser

 
Tablet 2 mg
Oral
30
5
Cabaser

 
Tablet 4 mg
Oral
30
5
Cabaser

Calcipotriol
Ointment 50 micrograms per g, 30 g
Application
1
1
Daivonex

 
Cream 50 micrograms (as monohydrate) per g, 30 g
Application
1
1
Daivonex

Calcitriol
Capsule 0.25 microgram
Oral
100
3
Calcitriol-DP

 
 
 
 
 
Citrihexal

 
 
 
 
 
GenRx Calcitriol

 
 
 
 
 
Kosteo

 
 
 
 
 
Rocaltrol

 
 
 
 
 
Sical

Calcium
Tablet 250 mg (as citrate)
Oral
120
1
Citracal

 
Tablet, chewable, 500 mg (as carbonate)
Oral
120
1
Cal-Sup

 
Tablet 600 mg (as carbonate)
Oral
120
1
Caltrate

Calcium Folinate
Tablet equivalent to 15 mg folinic acid
Oral
10
..
Leucovorin Calcium (Mayne Pharma Pty Ltd)

 
Injection equivalent to 50 mg folinic acid in 5 mL
Injection
5
5
Calcium Folinate Ebewe
Leucovorin Calcium (Mayne Pharma Pty Ltd)
Leucovorin Calcium (Pfizer Pty Limited)

 
Injection equivalent to 100 mg folinic acid in 10 mL
Injection
10
1
Calcium Folinate Ebewe
Leucovorin Calcium  (Pfizer Pty Limited)

 
Injection equivalent to 300 mg folinic acid in 30 mL
Injection
4
1
Leucovorin Calcium (Mayne Pharma Pty Ltd)

Candesartan
Tablet containing candesartan cilexetil 4 mg
Oral
30
5
Atacand

 
Tablet containing candesartan cilexetil 8 mg
Oral
30
5
Atacand

 
Tablet containing candesartan cilexetil 16 mg
Oral
30
5
Atacand

 
Tablet containing candesartan cilexetil 32 mg
Oral
30
5
Atacand

Candesartan with Hydrochlorothiazide
Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg
Oral
30
5
Atacand Plus 16/12.5

Capecitabine
Tablet 150 mg
Oral
60
2
Xeloda

 
Tablet 500 mg
Oral
120
2
Xeloda

"Caprilon"
Oral powder 420 g
Oral
8
5
Caprilon

Captopril
Tablet 12.5 mg
Oral
90
5
Acenorm 12.5 mg

 
 
 
 
 
Capoten

 
 
 
 
 
Captohexal

 
 
 
 
 
Chem mart Captopril

 
 
 
 
 
GenRx Captopril

 
 
 
 
 
Genepharm Pty Ltd

 
 
 
 
 
Terry White Chemists Captopril

 
 
 
 
 
Topace

 
Tablet 25 mg
Oral
90
5
Acenorm 25 mg

 
 
 
 
 
Capoten

 
 
 
 
 
Captohexal

 
 
 
 
 
Chem mart Captopril

 
 
 
 
 
GenRx Captopril

 
 
 
 
 
Genepharm Pty Ltd

 
 
 
 
 
Terry White Chemists Captopril

 
 
 
 
 
Topace

 
Tablet 50 mg
Oral
90
5
Acenorm 50 mg

 
 
 
 
 
Capoten

 
 
 
 
 
Captohexal

 
 
 
 
 
Chem mart Captopril

 
 
 
 
 
GenRx Captopril

 
 
 
 
 
Genepharm Pty Ltd

 
 
 
 
 
Terry White Chemists Captopril

 
 
 
 
 
Topace

 
Oral solution 5 mg per mL, 95 mL
Oral
1
5
Capoten

Carbamazepine
Tablet 100 mg
Oral
200
2
Carbamazepine Sandoz
Tegretol 100

 
Tablet 200 mg
Oral
200
2
Carbamazepine Sandoz
Tegretol 200
Teril

 
Tablet 200 mg (controlled release)
Oral
200
2
Tegretol CR 200

 
Tablet 400 mg (controlled release)
Oral
200
2
Tegretol CR 400

 
Oral suspension 100 mg per 5 mL, 300 mL
Oral
1
5
Tegretol Liquid

Carbimazole
Tablet 5 mg
Oral
200
2
Neo-Mercazole

"Carbohydrate Free Mixture"
Oral powder 225 g
Oral
24
5
Carbohydrate Free Mixture

Carbomer 974
Ocular lubricating gel 3 mg per g, single dose units 0.5 g, 30
Application to the eye
3
5
Poly Gel

Carbomer 980
Ocular lubricating gel 2 mg per g, 10 g
Application to the eye
1
5
GelTears
PAA
Viscotears Liquid Gel

 
Eye drops 2 mg per g, single dose units 0.6 mL, 30
Application to the eye
3
5
Viscotears

Carboplatin
Solution for I.V. injection 50 mg in 5 mL
Injection
2
..
Carboplatin Ebewe
Mayne Pharma Pty Ltd
Pfizer Pty Limited

 
Solution for I.V. injection 150 mg in 15 mL
Injection
6
..
Carboplatin Ebewe
Mayne Pharma Pty Ltd
Pfizer Pty Limited

 
Solution for I.V. injection 450 mg in 45 mL
Injection
2
..
Carboplatin Ebewe
Mayne Pharma Pty Ltd
Pfizer Pty Limited

Carmellose
Eye drops containing carmellose sodium 5 mg per mL, 15 mL
Application to the eye
1
5
Refresh Tears Plus

 
Eye drops containing carmellose sodium 10 mg per mL, 15 mL
Application to the eye
1
5
Refresh Liquigel

 
Eye drops containing carmellose sodium 2.5 mg per mL, single dose units 0.6 mL, 24
Application to the eye
4
5
TheraTears

 
Eye drops containing carmellose sodium 5 mg per mL, single dose units 0.4 mL, 30
Application to the eye
3
5
Cellufresh

 
Eye drops containing carmellose sodium 10 mg per mL, single dose units 0.4 mL, 30
Application to the eye
3
5
Celluvisc

 
Ocular lubricating gel containing carmellose sodium 10 mg per mL, single dose units 0.6 mL, 28
Application to the eye
3
5
TheraTears

Carmustine
Implants 7.7 mg, 8
Implantation
1
..
Gliadel

Carvedilol
Tablet 3.125 mg
Oral
30
..
Chem mart Carvedilol 3.125 mg

 
 
 
 
 
Dilatrend 3.125

 
 
 
 
 
GenRx Carvedilol

 
 
 
 
 
Kredex

 
 
 
 
 
Terry White Chemists Carvedilol 3.125 mg

 
Tablet 6.25 mg
Oral
60
5
Chem mart Carvedilol 6.25 mg

 
 
 
 
 
Dilatrend 6.25

 
 
 
 
 
GenRx Carvedilol

 
 
 
 
 
Kredex

 
 
 
 
 
Terry White Chemists Carvedilol 6.25 mg

 
Tablet 12.5 mg
Oral
60
5
Chem mart Carvedilol 12.5 mg

 
 
 
 
 
Dilatrend 12.5

 
 
 
 
 
GenRx Carvedilol

 
 
 
 
 
Kredex

 
 
 
 
 
Terry White Chemists Carvedilol 12.5 mg

 
Tablet 25 mg
Oral
60
5
Chem mart Carvedilol 25 mg

 
 
 
 
 
Dilatrend 25

 
 
 
 
 
GenRx Carvedilol

 
 
 
 
 
Kredex

 
 
 
 
 
Terry White Chemists Carvedilol 25 mg

Cefaclor
Tablet (sustained release) 375 mg (as monohydrate)
Oral
10
1
Ceclor CD

 
 
 
 
 
Chem mart Cefaclor CD

 
 
 
 
 
Douglas Cefaclor-CD

 
 
 
 
 
GenRx Cefaclor CD

 
 
 
 
 
Karlor CD

 
 
 
 
 
Keflor CD

 
 
 
 
 
Ozcef

 
 
 
 
 
Terry White Chemists Cefaclor CD

 
Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL
Oral
1
1
Aclor 125
Ceclor

 
 
 
 
 
Chem mart Cefaclor

 
 
 
 
 
GenRx Cefaclor

 
 
 
 
 
Keflor

 
 
 
 
 
Terry White Chemists Cefaclor

 
Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL
Oral
1
1
Aclor 250
Ceclor

 
 
 
 
 
Chem mart Cefaclor

 
 
 
 
 
GenRx Cefaclor

 
 
 
 
 
Keflor

 
 
 
 
 
Terry White Chemists Cefaclor

Cefepime
Powder for injection 1 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent)
Injection
10
..
Maxipime

 
Powder for injection 2 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent)
Injection
10
..
Maxipime

Cefotaxime
Powder for injection 1 g (as sodium)
Injection
10
..
Cefotaxime Sandoz
Mayne Pharma Pty Ltd

 
Powder for injection 2 g (as sodium)
Injection
10
..
Cefotaxime Sandoz
Mayne Pharma Pty Ltd

Ceftriaxone
Powder for injection 500 mg (as sodium)
Injection
1
..
Ceftriaxone ICP

 
Powder for injection 1 g (as sodium)
Injection
5
..
Ceftriaxone ICP

 
 
 
 
 
Ceftriaxone Sandoz

 
 
 
 
 
DBL Ceftriaxone

 
 
 
 
 
Rocephin

 
Powder for injection 2 g (as sodium)
Injection
5
..
Ceftriaxone ICP

 
 
 
 
 
Ceftriaxone Sandoz

 
 
 
 
 
DBL Ceftriaxone

 
 
 
 
 
Rocephin

Cefuroxime
Tablet 250 mg (as axetil)
Oral
14
1
Zinnat

Celecoxib
Capsule 100 mg
Oral
60
3
Celebrex

 
Capsule 200 mg
Oral
30
3
Celebrex

Cephalexin
Capsule 250 mg (anhydrous)
Oral
20
1
Chem mart Cephalexin

 
 
 
 
 
Cilex

 
 
 
 
 
GenRx Cephalexin

 
 
 
 
 
Ialex

 
 
 
 
 
Ibilex 250

 
 
 
 
 
Keflex

 
 
 
 
 
Rancef

 
 
 
 
 
Sporahexal

 
 
 
 
 
Terry White Chemists Cephalexin

 
Capsule 500 mg (anhydrous)
Oral
20
1
Chem mart Cephalexin

 
 
 
 
 
Cilex

 
 
 
 
 
GenRx Cephalexin

 
 
 
 
 
Ialex

 
 
 
 
 
Ibilex 500

 
 
 
 
 
Keflex

 
 
 
 
 
Rancef

 
 
 
 
 
Sporahexal

 
 
 
 
 
Terry White Chemists Cephalexin

 
Granules for oral suspension 125 mg per 5 mL, 100 mL
Oral
1
1
Chem mart Cephalexin

 
 
 
 
 
Cilex

 
 
 
 
 
GenRx Cephalexin

 
 
 
 
 
Ialex

 
 
 
 
 
Ibilex 125

 
 
 
 
 
Keflex

 
 
 
 
 
Terry White Chemists Cephalexin

 
Granules for oral suspension 250 mg per 5 mL, 100 mL
Oral
1
1
Chem mart Cephalexin

 
 
 
 
 
Cilex

 
 
 
 
 
GenRx Cephalexin

 
 
 
 
 
Ialex

 
 
 
 
 
Ibilex 250

 
 
 
 
 
Keflex

 
 
 
 
 
Terry White Chemists Cephalexin

Cephalothin
Powder for injection 1 g (as sodium)
Injection
10
1
Keflin Neutral
Mayne Pharma Pty Ltd

Cephazolin
Powder for injection 500 mg (as sodium)
Injection
10
..
Mayne Pharma Pty Ltd

 
Powder for injection 1 g (as sodium)
Injection
10
..
Cefazolin Sandoz
Kefzol
Mayne Pharma Pty Ltd

Chlorambucil
Tablet 2 mg
Oral
100
2
Leukeran

Chloramphenicol
Ear drops (aqueous) 5 mg per mL, 5 mL
Application to the ear
1
2
Chloromycetin

 
Eye drops 5 mg per mL, 10 mL
Application to the eye
1
2
Chloromycetin
Chlorsig

 
Eye ointment 10 mg per g, 4 g
Application to the eye
1
..
Chloromycetin
Chlorsig

Chlorpromazine
Tablet containing chlorpromazine hydrochloride 10 mg
Oral
100
5
Largactil

 
Tablet containing chlorpromazine hydrochloride 25 mg
Oral
100
5
Largactil

 
Tablet containing chlorpromazine hydrochloride 100 mg
Oral
100
5
Largactil

 
Oral solution containing chlorpromazine hydrochloride 25 mg per 5 mL, 100 mL
Oral
1
5
Largactil

 
Injection containing chlorpromazine hydrochloride 50 mg in 2 mL
Injection
10
..
Largactil

Chlorthalidone
Tablet 25 mg
Oral
100
1
Hygroton 25

Cholestyramine
Sachets containing 4.7 g oral powder (equivalent to 4 g cholestyramine), 50
Oral
2
5
Questran Lite

 
Sachets containing 9.4 g oral powder (equivalent to 8 g cholestyramine), 50
Oral
1
5
Questran Lite

Chorionic Gonadotrophin
Injection set containing 3 ampoules powder for injection 500 units and 3 ampoules solvent 1 mL
Injection
1
5
Pregnyl

 
Injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL
Injection
1
5
Pregnyl

Ciclesonide
Pressurised inhalation 80 micrograms per dose, 120 doses (CFC-free formulation)
Inhalation by mouth
1
5
Alvesco 80

 
Pressurised inhalation 160 micrograms per dose, 120 doses (CFC-free formulation)
Inhalation by mouth
1
5
Alvesco 160

Cimetidine
Tablet 200 mg
Oral
120
5
Magicul 200
Tagamet

 
Tablet 400 mg
Oral
60
5
GenRx Cimetidine
Magicul 400
Tagamet

 
Tablet 800 mg
Oral
30
5
GenRx Cimetidine
Magicul 800

Ciprofloxacin
Tablet 500 mg (as hydrochloride)
Oral
14
..
C-Flox 500

 
 
 
 
 
Ciprofloxacin 500

 
 
 
 
 
Ciprofloxacin-BC

 
 
 
 
 
Ciprofloxacin-BW

 
 
 
 
 
Ciprol 500

 
 
 
 
 
Ciproxin 500

 
 
 
 
 
GenRx Ciprofloxacin

 
 
 
 
 
Genepharm Australasia Limited

 
 
 
 
 
Profloxin

 
 
 
 
 
Proquin

 
Tablet 750 mg (as hydrochloride)
Oral
14
..
C-Flox 750

 
 
 
 
 
Ciprofloxacin 750

 
 
 
 
 
Ciprofloxacin-BW

 
 
 
 
 
Ciprol 750

 
 
 
 
 
Ciproxin 750

 
 
 
 
 
GenRx Ciprofloxacin

 
 
 
 
 
Genepharm Australasia Limited

 
 
 
 
 
Profloxin

 
 
 
 
 
Proquin

 
Tablet 250 mg (as hydrochloride)
Oral
2
..
Ciproxin 250

 
Ear drops 3 mg (as hydrochloride) per mL, 5 mL
Application to the ear
1
1
Ciloxan

 
Eye drops 3 mg (as hydrochloride) per mL, 5 mL
Application to the eye
2
..
CiloQuin
Ciloxan

Cisplatin
I.V. injection 10 mg in 10 mL
Injection
1
..
Pfizer Pty Limited

 
I.V. injection 50 mg in 50 mL
Injection
1
..
Mayne Pharma Pty Ltd
Pfizer Pty Limited

 
I.V. injection 100 mg in 100 mL
Injection
1
..
Cisplatin Ebewe
Mayne Pharma Pty Ltd

Citalopram
Tablet 10 mg (as hydrobromide)
Oral
28
5
Celapram

 
Tablet 20 mg (as hydrobromide)
Oral
28
5
Celapram

 
 
 
 
 
Chem mart Citalopram

 
 
 
 
 
Ciazil

 
 
 
 
 
Cipramil

 
 
 
 
 
Citalopram 20

 
 
 
 
 
Citalopram-RL

 
 
 
 
 
Citalopram Winthrop

 
 
 
 
 
GenRx Citalopram

 
 
 
 
 
Talam

 
 
 
 
 
Talohexal

 
 
 
 
 
Terry White Chemists Citalopram

 
Tablet 40 mg (as hydrobromide)
Oral
28
5
Celapram
GenRx Citalopram
Talohexal

Cladribine
Injection 10 mg in 5 mL vial
Injection
7
..
Litak

 
Solution for I.V. infusion 10 mg in 10 mL single use vial
Injection
7
..
Leustatin

Clarithromycin
Tablet 250 mg
Oral
14
1
Chem mart Clarithromycin

 
 
 
 
 
Clarac

 
 
 
 
 
Clarihexal

 
 
 
 
 
Clarithro 250

 
 
 
 
 
GenRx Clarithromycin

 
 
 
 
 
Kalixocin

 
 
 
 
 
Klacid

 
 
 
 
 
Terry White Chemists Clarithromycin

Clindamycin
Capsule 150 mg (as hydrochloride)
Oral
25
..
Cleocin
Dalacin C

Clodronic Acid
Capsule containing 400 mg sodium clodronate (as tetrahydrate)
Oral
100
2
Bonefos

 
Capsule containing 800 mg sodium clodronate (as tetrahydrate)
Oral
60
2
Bonefos 800 mg

Clomiphene
Tablet containing clomiphene citrate 50 mg
Oral
10
5
Clomhexal

 
 
 
 
 
Clomid

 
 
 
 
 
Fermil

 
 
 
 
 
GenRx Clomiphene

 
 
 
 
 
Serophene

Clomipramine
Tablet containing clomipramine hydrochloride 25 mg
Oral
50
2
Anafranil 25

 
 
 
 
 
Chem mart Clomipramine

 
 
 
 
 
GenRx Clomipramine

 
 
 
 
 
Placil

 
 
 
 
 
Terry White Chemists Clomipramine

Clonazepam
Tablet 500 micrograms
Oral
200
2
Paxam 0.5
Rivotril

 
Tablet 2 mg
Oral
200
2
Paxam 2
Rivotril

 
Oral liquid 2.5 mg per mL, 10 mL
Oral
2
..
Rivotril

 
Injection 1 mg in 2 mL (set containing solution 1 mg in 1 mL and 1 mL diluent)
Injection
5
..
Rivotril

Clonidine
Tablet containing clonidine hydrochloride 100 micrograms
Oral
100
5
Catapres 100

 
Tablet containing clonidine hydrochloride 150 micrograms
Oral
100
5
Catapres

Clopidogrel
Tablet 75 mg (as hydrogen sulfate)
Oral
28
5
Iscover
Plavix

Clotrimazole
Lotion 10 mg per mL, 20 mL
Application
2
3
Canesten

Coal Tar - Prepared
Gel 10 mg per g, 100 mL
Application
1
2
Exorex

Codeine
Tablet containing codeine phosphate 30 mg
Oral
20
..
Fawns and McAllan Pty Ltd

Codeine with Paracetamol
Tablet containing codeine phosphate 30 mg with paracetamol 500 mg
Oral
20
..
Codalgin Forte
Codapane Forte

 
 
 
 
 
Dolaforte

 
 
 
 
 
Dymadon Forte

 
 
 
 
 
Panadeine Forte

 
 
 
 
 
Prodeine Forte

Colchicine
Tablet 500 micrograms
Oral
100
2
Colgout
Lengout

Colestipol
Oral powder, sachets containing colestipol hydrochloride 5 g, 120
Oral
1
5
Colestid

Copper Sulfate
Tablets, diagnostic compound, 36
For external use   
2
3
Clinitest

Cortisone
Tablet containing cortisone acetate 5 mg
Oral
50
4
Cortate

 
Tablet containing cortisone acetate 25 mg
Oral
60
4
Cortate

Cromoglycic Acid
Capsule containing powder for oral inhalation containing sodium cromoglycate 20 mg (for use in Intal Spinhaler or Intal Halermatic)
Inhalation by mouth
100
5
Intal Spincaps

 
Pressurised inhalation containing sodium cromoglycate 1 mg per dose, 200 doses
Inhalation by mouth
1
5
Intal

 
Pressurised inhalation containing sodium cromoglycate 1 mg per dose, 200 doses (CFC-free formulation)
Inhalation by mouth
1
5
Intal CFC-Free

 
Pressurised inhalation containing sodium cromoglycate 5 mg per dose, 112 doses (CFC-free formulation)
Inhalation by mouth
1
5
Intal Forte CFC-Free

 
Eye drops containing sodium cromoglycate 20 mg per mL, 10 mL
Application to the eye
1
5
Cromolux
Opticrom

Cyclophosphamide
Tablet 50 mg
Oral
50
2
Cycloblastin

 
Powder for injection 500 mg (anhydrous) (with any determined brand of sodium chloride injection as the required solvent)
Injection
2
..
Endoxan

 
Powder for injection 1 g (anhydrous) (with any determined brand of sodium chloride injection as the required solvent)
Injection
1
..
Endoxan

 
Powder for injection 2 g (anhydrous) (with any determined brand of sodium chloride injection as the required solvent)
Injection
1
..
Endoxan

Cyclosporin
Capsule 10 mg
Oral
120
3
Neoral 10

 
Capsule 25 mg
Oral
60
3
Cicloral
Neoral 25

 
Capsule 50 mg
Oral
60
3
Cicloral
Neoral 50

 
Capsule 100 mg
Oral
60
3
Cicloral
Neoral 100

 
Oral liquid 100 mg per mL, 50 mL
Oral
2
3
Neoral

Cyproheptadine
Tablet containing cyproheptadine hydrochloride 4 mg (anhydrous)
Oral
100
2
Periactin

Cyproterone
Tablet containing cyproterone acetate 50 mg
Oral
20
5
Androcur

 
 
 
 
 
Cyprohexal

 
 
 
 
 
Cyprone

 
 
 
 
 
Cyprostat

 
 
 
 
 
GenRx Cyproterone Acetate

 
 
 
 
 
Procur

 
Tablet containing cyproterone acetate 100 mg
Oral
50
5
Androcur-100

 
 
 
 
 
Cyprohexal

 
 
 
 
 
Cyprostat-100

 
 
 
 
 
GenRx Cyproterone Acetate

 
 
 
 
 
Procur 100

Cytarabine
Injection 100 mg in 5 mL vial
Injection
10
1
Pfizer Pty Limited

Dalteparin
Injection containing dalteparin sodium 2,500 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe
Injection
10
1
Fragmin

 
Injection containing dalteparin sodium 5,000 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe
Injection
10
1
Fragmin

 
Injection containing dalteparin sodium 7,500 I.U. (anti-Xa) in 0.75 mL single dose pre-filled syringe
Injection
10
1
Fragmin

 
Injection containing dalteparin sodium 10,000 I.U. (anti-Xa) in 1 mL single dose pre-filled syringe
Injection
10
1
Fragmin

Danazol
Capsule 100 mg
Oral
100
5
Azol 100

 
Capsule 200 mg
Oral
100
5
Azol 200

Dantrolene
Capsule containing dantrolene sodium 25 mg
Oral
100
2
Dantrium

 
Capsule containing dantrolene sodium 50 mg
Oral
100
2
Dantrium

Dapsone
Tablet 25 mg
Oral
100
1
Link Medical Products Pty Ltd

 
Tablet 100 mg
Oral
100
1
Link Medical Products Pty Ltd

Dasatinib
Tablet 20 mg
Oral
60
5
Sprycel

 
Tablet 50 mg
Oral
60
5
Sprycel

 
Tablet 70 mg
Oral
60
5
Sprycel

Desmopressin
Intranasal solution containing desmopressin acetate 100 micrograms per mL, 2.5 mL dropper bottle
Nasal
5
5
Minirin

 
Tablet containing desmopressin acetate 200 micrograms
Oral
30
5
Minirin

 
Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 60 actuations, 6 mL
Nasal
1
5
Minirin Nasal Spray

Dexamethasone
Tablet 500 micrograms
Oral
30
4
Dexmethsone

 
Tablet 4 mg
Oral
30
4
Dexmethsone

 
Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL
Injection
5
..
Mayne Pharma Pty Ltd

 
Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL
Injection
5
1
Mayne Pharma Pty Ltd

 
Injection containing dexamethasone sodium phosphate equivalent to 120 mg dexamethasone phosphate in 5 mL
Injection
1
..
Mayne Pharma Pty Ltd

 
Eye drops 1 mg per mL, 5 mL
Application to the eye
1
2
Maxidex

Dexamethasone with Framycetin and Gramicidin
Ear drops containing dexamethasone 500 micrograms (as sodium metasulfobenzoate), framycetin sulfate 5 mg and gramicidin 50 micrograms per mL, 8 mL
Application to the ear
1
2
Otodex
Sofradex

Dexamphetamine
Tablet containing dexamphetamine sulfate 5 mg
Oral
100
5
Sigma Pharmaceuticals Pty Ltd

"Dialamine"
Oral powder 200 g
Oral
10
5
Dialamine

Diazepam
Tablet 2 mg
Oral
50
..
Antenex 2

 
 
 
 
 
Ducene

 
 
 
 
 
Valium

 
 
 
 
 
Valpam 2

 
Tablet 5 mg
Oral
50
..
Antenex 5

 
 
 
 
 
Diazepam-DP

 
 
 
 
 
Ducene

 
 
 
 
 
Valium

 
 
 
 
 
Valpam 5

 
Injection 10 mg in 2 mL ampoule
Injection
5
..
Mayne Pharma Pty Ltd

Diclofenac
Tablet (enteric coated) containing diclofenac sodium 25 mg
Oral
100
3
Chem mart Diclofenac

 
 
 
 
 
Clonac 25

 
 
 
 
 
Diclohexal

 
 
 
 
 
Dinac

 
 
 
 
 
Fenac 25

 
 
 
 
 
GenRx Diclofenac

 
 
 
 
 
Terry White Chemists Diclofenac

 
 
 
 
 
Voltaren 25

 
Tablet (enteric coated) containing diclofenac sodium 50 mg
Oral
50
3
Chem mart Diclofenac

 
 
 
 
 
Clonac 50

 
 
 
 
 
Diclohexal

 
 
 
 
 
Dinac

 
 
 
 
 
Fenac

 
 
 
 
 
GenRx Diclofenac

 
 
 
 
 
Terry White Chemists Diclofenac

 
 
 
 
 
Voltaren 50

 
Suppository containing diclofenac sodium 100 mg
Rectal
40
3
Voltaren 100

Dicloxacillin
Capsule 250 mg (as sodium)
Oral
24
..
Diclocil
Dicloxsig
Distaph 250

 
Capsule 500 mg (as sodium)
Oral
24
..
Diclocil
Dicloxsig
Distaph 500

 
Powder for injection 500 mg (as sodium)
Injection
5
..
Diclocil

 
Powder for injection 1 g (as sodium)
Injection
5
1
Diclocil

"Digestelact"
Oral powder 900 g
Oral
3
1
Digestelact

Digoxin
Tablet 62.5 micrograms
Oral
200
1
Lanoxin-PG
Sigmaxin-PG

 
Tablet 250 micrograms
Oral
100
1
Lanoxin
Sigmaxin

 
Paediatric oral solution 50 micrograms per mL, 60 mL
Oral
2
3
Lanoxin

Dihydroergotamine
Injection containing dihydroergotamine mesylate 1 mg in 1 mL
Injection
5
..
Dihydergot

Diltiazem
Tablet containing diltiazem hydrochloride 60 mg
Oral
90
5
Cardizem

 
 
 
 
 
Chem mart Diltiazem

 
 
 
 
 
Coras

 
 
 
 
 
Diltahexal

 
 
 
 
 
Dilzem 60 mg

 
 
 
 
 
GenRx Diltiazem

 
 
 
 
 
Terry White Chemists Diltiazem

 
 
 
 
 
Vasocardol

 
Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg
Oral
30
5
Cardizem CD
Chem mart Diltiazem CD

 
 
 
 
 
Diltahexal CD

 
 
 
 
 
Dilzem CD

 
 
 
 
 
GenRx Diltiazem CD

 
 
 
 
 
Terry White Chemists Diltiazem CD

 
 
 
 
 
Vasocardol CD

 
Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg
Oral
30
5
Cardizem CD
Chem mart Diltiazem CD

 
 
 
 
 
Diltahexal CD

 
 
 
 
 
Dilzem CD

 
 
 
 
 
GenRx Diltiazem CD

 
 
 
 
 
Terry White Chemists Diltiazem CD

 
 
 
 
 
Vasocardol CD

 
Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg
Oral
30
5
Cardizem CD
Diltahexal CD
Vasocardol CD

Diphenoxylate with Atropine
Tablet containing diphenoxylate hydrochloride 2.5 mg with atropine sulfate 25 micrograms
Oral
20
..
Lofenoxal
Lomotil

Diphtheria and Tetanus Vaccine - Adsorbed
Injection 0.5 mL ampoule
Injection
3
..
Aspen Pharmacare Australia Pty Ltd

Diphtheria and Tetanus Vaccine - Adsorbed (Diluted)
Injection 0.5 mL in pre-filled syringe
Injection
5
..
ADT Booster

Dipivefrine
Eye drops containing dipivefrine hydrochloride 1 mg per mL, 10 mL
Application to the eye
1
5
Propine

Dipyridamole
Capsule 200 mg (sustained release)
Oral
60
5
Persantin SR

Dipyridamole with Aspirin
Capsule 200 mg (sustained release)-25 mg
Oral
60
5
Asasantin SR

Disopyramide
Capsule 100 mg
Oral
100
5
Rythmodan

 
Capsule 150 mg
Oral
100
5
Rythmodan

Docetaxel
Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL and 1 single use vial solvent 1.5 mL
Injection
2
..
Taxotere

 
Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL and 1 single use vial solvent 6 mL
Injection
1
..
Taxotere

Dolasetron
Tablet containing dolasetron mesylate 200 mg
Oral
2
..
Anzemet

 
I.V. injection containing dolasetron mesylate 100 mg in 5 mL
Injection
1
..
Anzemet

Domperidone
Tablet 10 mg
Oral
25
..
Motilium

Donepezil
Tablet containing donepezil hydrochloride 5 mg
Oral
28
5
Aricept

 
Tablet containing donepezil hydrochloride 10 mg
Oral
28
5
Aricept

Dorzolamide
Eye drops 20 mg (as hydrochloride) per mL, 5 mL
Application to the eye
1
5
Trusopt

Dorzolamide with Timolol
Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL
Application to the eye
1
5
Cosopt

Dothiepin
Capsule containing dothiepin hydrochloride 25 mg
Oral
50
2
Dothep 25
Prothiaden

 
Tablet containing dothiepin hydrochloride 75 mg
Oral
30
2
Dothep 75
Prothiaden

Doxepin
Tablet 50 mg (as hydrochloride)
Oral
50
2
Deptran 50

 
Capsule 10 mg (as hydrochloride)
Oral
50
2
Deptran 10
Sinequan

 
Capsule 25 mg (as hydrochloride)
Oral
50
2
Deptran 25
Sinequan

Doxorubicin
Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial
Injection/intravesical
4
..
Adriamycin Solution
Doxorubicin Ebewe
Mayne Pharma Pty Ltd

 
Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 20 mg in 10 mL single dose vial
Injection/intravesical
4
..
Adriamycin Solution

 
Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial
Injection/intravesical
3
..
Adriamycin Solution
Doxorubicin Ebewe
Mayne Pharma Pty Ltd

 
Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 100 mg in 50 mL single dose vial
Injection/intravesical
1
..
Doxorubicin Ebewe

 
Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial
Injection/intravesical
1
..
Adriamycin
Doxorubicin Ebewe

Doxorubicin - Pegylated Liposomal
Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL
Injection
1
..
Caelyx

 
Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL
Injection
1
..
Caelyx

Doxycycline
Tablet 50 mg (as hydrochloride)
Oral
25
5
Doxy-50
Doxylin 50
Vibra-Tabs

 
Tablet 50 mg (as monohydrate)
Oral
25
5
Chem mart Doxycycline

 
 
 
 
 
Doxyhexal

 
 
 
 
 
Frakas

 
 
 
 
 
GenRx Doxycycline

 
 
 
 
 
Terry White Chemists Doxycycline

 
Capsule 50 mg (as hydrochloride) (containing enteric coated pellets)
Oral
25
5
DBL Doxycycline
Doryx

 
Tablet 100 mg (as hydrochloride)
Oral
7
1
Doxsig

 
 
 
 
 
Doxy-100

 
 
 
 
 
Doxylin 100

 
 
 
 
 
Vibramycin

 
Tablet 100 mg (as monohydrate)
Oral
7
1
Chem mart Doxycycline

 
 
 
 
 
Doxyhexal

 
 
 
 
 
GenRx Doxycycline

 
 
 
 
 
Terry White Chemists Doxycycline

 
Capsule 100 mg (as hydrochloride) (containing enteric coated pellets)
Oral
7
1
DBL Doxycycline
Doryx

Drotrecogin Alfa (activated)
Powder for I.V. infusion 5 mg
Injection
1
..
Xigris

 
Powder for I.V. infusion 20 mg
Injection
1
..
Xigris

"Duocal"
Oral powder 400 g
Oral
8
5
Duocal

Dydrogesterone
Tablet 10 mg
Oral
28
2
Duphaston

"Easiphen"
Oral liquid 250 mL
Oral
90
5
Easiphen

Efalizumab
Injection set containing 4 vials powder for injection 125 mg and 4 pre-filled syringes diluent 1.3 mL
Injection
1
3
Raptiva

Eformoterol
Capsule containing powder for oral inhalation containing eformoterol fumarate dihydrate 12 micrograms (for use in Foradile Aerolizer)
Inhalation by mouth
60
5
Foradile

 
Powder for oral inhalation in breath actuated device containing eformoterol fumarate dihydrate 6 micrograms per dose, 60 doses
Inhalation by mouth
1
5
Oxis Turbuhaler

 
Powder for oral inhalation in breath actuated device containing eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses
Inhalation by mouth
1
5
Oxis Turbuhaler

"EleCare"
Oral powder 400 g
Oral
8
5
EleCare

Electrolyte Replacement, Oral
Oral rehydration salts containing glucose 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10
Oral
1
..
Chem mart Oral Rehydration Salts
O.R.S.

 
 
 
 
 
Repalyte New Formulation

 
 
 
 
 
restore O.R.S.

 
 
 
 
 
Terry White Chemists Oral Rehydration Salts

Electrolyte Replacement, Solution
Electrolyte replacement solution containing sodium chloride 5.26 g, sodium acetate 3.68 g, sodium gluconate 5.02 g, potassium chloride 370 mg and magnesium chloride 300 mg per L, 1 L
Injection
2
1
Plasma-Lyte 148

Enalapril
Tablet containing enalapril maleate 5 mg
Oral
30
5
Alphapril

 
 
 
 
 
Auspril

 
 
 
 
 
Chem mart Enalapril

 
 
 
 
 
Enahexal

 
 
 
 
 
Enalabell

 
 
 
 
 
Enalapril-DP 5mg

 
 
 
 
 
Enalapril Winthrop

 
 
 
 
 
GenRx Enalapril

 
 
 
 
 
Renitec M

 
 
 
 
 
Terry White Chemists Enalapril

 
Tablet containing enalapril maleate 10 mg
Oral
30
5
Alphapril

 
 
 
 
 
Amprace 10

 
 
 
 
 
Auspril

 
 
 
 
 
Chem mart Enalapril

 
 
 
 
 
Enahexal

 
 
 
 
 
Enalabell

 
 
 
 
 
Enalapril-DP 10mg

 
 
 
 
 
Enalapril Winthrop

 
 
 
 
 
GenRx Enalapril

 
 
 
 
 
Renitec

 
 
 
 
 
Terry White Chemists Enalapril

 
Tablet containing enalapril maleate 20 mg
Oral
30
5
Alphapril

 
 
 
 
 
Amprace 20

 
 
 
 
 
Auspril

 
 
 
 
 
Chem mart Enalapril

 
 
 
 
 
Enahexal

 
 
 
 
 
Enalabell

 
 
 
 
 
Enalapril-DP 20mg

 
 
 
 
 
Enalapril Winthrop

 
 
 
 
 
GenRx Enalapril

 
 
 
 
 
Renitec 20

 
 
 
 
 
Terry White Chemists Enalapril

Enalapril with Hydrochlorothiazide
Tablet containing enalapril maleate 20 mg with hydrochlorothiazide 6 mg
Oral
30
5
Renitec Plus 20/6

"Energivit"
Oral powder 400 g
Oral
8
5
Energivit

Enoxaparin
Injection containing enoxaparin sodium 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre-filled syringe
Injection
10
1
Clexane

 
Injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in 0.4 mL pre-filled syringe
Injection
10
1
Clexane

 
Injection containing enoxaparin sodium 60 mg (6,000 I.U. anti-Xa) in 0.6 mL pre-filled syringe
Injection
10
1
Clexane

 
Injection containing enoxaparin sodium 80 mg (8,000 I.U. anti-Xa) in 0.8 mL pre-filled syringe
Injection
10
1
Clexane

 
Injection containing enoxaparin sodium 100 mg (10,000 I.U. anti-Xa) in 1 mL pre-filled syringe
Injection
10
1
Clexane

Entacapone
Tablet 200 mg
Oral
200
4
Comtan

Epirubicin
Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL
Injection/intravesical
4
..
Epirubicin Ebewe
Pharmorubicin Solution

 
Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL
Injection/intravesical
4
..
Pharmorubicin Solution

 
Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL
Injection/intravesical
4
..
Epirubicin Ebewe
Mayne Pharma Pty Ltd
Pharmorubicin Solution

 
Powder for injection containing epirubicin hydrochloride 50 mg
Injection/intravesical
4
..
Mayne Pharma Pty Ltd

 
Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL
Injection/intravesical
2
..
Epirubicin Ebewe
Mayne Pharma Pty Ltd

 
Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL
Injection/intravesical
1
..
Epirubicin Ebewe

Eplerenone
Tablet 25 mg
Oral
30
5
Inspra

 
Tablet 50 mg
Oral
30
5
Inspra

Eprosartan
Tablet 400 mg (as mesylate)
Oral
56
5
Teveten

 
Tablet 600 mg (as mesylate)
Oral
28
5
Teveten

Eprosartan with Hydrochlorothiazide
Tablet 600 mg eprosartan (as mesylate) with 12.5 mg hydrochlorothiazide
Oral
28
5
Teveten Plus 600/12.5

Eptifibatide
Solution for I.V. injection 20 mg (as acetate) in 10 mL
Injection
2
..
Integrilin

 
Solution for I.V. infusion 75 mg (as acetate) in 100 mL
Injection
3
..
Integrilin

Erythromycin
Tablet 400 mg (as ethyl succinate)
Oral
25
1
E.E.S. 400 Filmtab
E-Mycin

 
Capsule 250 mg (containing enteric coated pellets)
Oral
25
1
DBL Erythromycin
Eryc

 
Powder for oral liquid 200 mg (as ethyl succinate) per 5 mL, 100 mL
Oral
1
1
E.E.S. 200
E-Mycin 200

 
Powder for oral liquid 400 mg (as ethyl succinate) per 5 mL, 100 mL
Oral
1
1
E.E.S. Granules
E-Mycin 400

 
Powder for I.V. infusion 1 g (as lactobionate)
Injection
5
..
Erythrocin-I.V.

Escitalopram
Tablet 10 mg (as oxalate)
Oral
28
5
Esipram
Lexapro

 
Tablet 20 mg (as oxalate)
Oral
28
5
Esipram
Lexapro

 
Oral solution 10 mg (as oxalate) per mL, 28 mL
Oral
1
5
Lexapro

Esomeprazole
Tablet (enteric coated) 20 mg (as magnesium trihydrate)
Oral
30
1
Nexium

 
Tablet (enteric coated) 40 mg (as magnesium trihydrate)
Oral
30
1
Nexium

Esomeprazole and Clarithromycin and Amoxycillin
Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium trihydrate), 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate)
Oral
1
..
Nexium Hp7

Etanercept
Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL
Injection
2
2
Enbrel

 
Injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL
Injection
1
2
Enbrel

 
Injections 50 mg in 1 mL single use pre-filled syringes, 4
Injection
1
2
Enbrel

Ethacrynic Acid
Tablet 25 mg
Oral
200
1
Edecrin

Ethosuximide
Capsule 250 mg
Oral
200
2
Zarontin

 
Oral solution 250 mg per 5 mL, 200 mL
Oral
1
5
Zarontin

Etidronic Acid
Tablet containing disodium etidronate 200 mg
Oral
60
5
Didronel

Etidronic Acid and Calcium
Pack containing 28 tablets disodium etidronate 200 mg and 76 tablets calcium 500 mg (as carbonate)
Oral
1
1
Didrocal

Etonogestrel
Subcutaneous implant 68 mg
Implantation
1
..
Implanon

Etoposide
Capsule 50 mg
Oral
20
..
Vepesid

 
Capsule 100 mg
Oral
10
..
Vepesid

 
Solution for I.V. infusion 100 mg in 5 mL vial
Injection
5
..
Etoposide Ebewe
Mayne Pharma Pty Ltd

 
Powder for I.V. infusion containing etoposide phosphate 113.6 mg
Injection
5
..
Etopophos

 
Powder for I.V. infusion containing etoposide phosphate 1.136 g
Injection
1
..
Etopophos

Everolimus
Tablet 0.25 mg
Oral
60
3
Certican

 
Tablet 0.5 mg
Oral
60
3
Certican

 
Tablet 0.75 mg
Oral
120
3
Certican

Exemestane
Tablet 25 mg
Oral
30
5
Aromasin

Ezetimibe
Tablet 10 mg
Oral
30
5
Ezetrol

Ezetimibe with Simvastatin
Tablet 10 mg-40 mg
Oral
30
5
Vytorin

 
Tablet 10 mg-80 mg
Oral
30
5
Vytorin

Famciclovir
Tablet 125 mg
Oral
40
1
Famvir

 
Tablet 250 mg
Oral
21
..
Famvir

 
Tablet 500 mg
Oral
30
..
Famvir

Famotidine
Tablet 20 mg
Oral
60
5
Ausfam 20

 
 
 
 
 
Chem mart Famotidine

 
 
 
 
 
Famohexal

 
 
 
 
 
GenRx Famotidine

 
 
 
 
 
Pamacid 20

 
 
 
 
 
Pepcidine M

 
 
 
 
 
Pepzan

 
 
 
 
 
Terry White Chemists Famotidine

 
Tablet 40 mg
Oral
30
5
Ausfam 40

 
 
 
 
 
Chem mart Famotidine

 
 
 
 
 
Famohexal

 
 
 
 
 
GenRx Famotidine

 
 
 
 
 
Pamacid 40

 
 
 
 
 
Pepcidine

 
 
 
 
 
Pepzan

 
 
 
 
 
Terry White Chemists Famotidine

Felodipine
Tablet 2.5 mg (extended release)
Oral
30
5
Felodur ER 2.5 mg
Plendil ER

 
Tablet 5 mg (extended release)
Oral
30
5
Felodur ER 5 mg
Plendil ER

 
Tablet 10 mg (extended release)
Oral
30
5
Felodur ER 10 mg
Plendil ER

Fenofibrate
Tablet 48 mg
Oral
60
5
Lipidil

 
Tablet 145 mg
Oral
30
5
Lipidil

Fentanyl
Transdermal patch 2.1 mg
Transdermal
5
..
Durogesic 12

 
Transdermal patch 4.2 mg
Transdermal
5
..
Durogesic 25

 
Transdermal patch 8.4 mg
Transdermal
5
..
Durogesic 50

 
Transdermal patch 12.6 mg
Transdermal
5
..
Durogesic 75

 
Transdermal patch 16.8 mg
Transdermal
5
..
Durogesic 100

Ferrous Fumarate with Folic Acid
Tablet 310 mg (equivalent to 100 mg iron)-350 micrograms
Oral
60
1
Ferro-f-tab

Ferrous Sulfate
Oral liquid 30 mg per mL, 250 mL
Oral
1
2
Ferro-Liquid

Flecainide
Tablet containing flecainide acetate 50 mg
Oral
60
5
Tambocor

 
Tablet containing flecainide acetate 100 mg
Oral
60
5
Flecatab
Tambocor

Flucloxacillin
Capsule 250 mg (as sodium)
Oral
24
..
Flopen
Floxapen
Staphylex 250

 
Capsule 500 mg (as sodium)
Oral
24
..
Flopen
Floxapen
Staphylex 500

 
Powder for oral suspension 125 mg (as magnesium) per 5 mL, 100 mL
Oral
1
..
Floxapen

 
Powder for oral suspension 250 mg (as magnesium) per 5 mL, 100 mL
Oral
1
..
Flopen
Floxapen

 
Powder for injection 500 mg (as sodium)
Injection
5
..
Flopen
Flubiclox

 
Powder for injection 1 g (as sodium)
Injection
5
1
Aspen Flucil

 
 
 
 
 
Flopen

 
 
 
 
 
Flubiclox

 
 
 
 
 
Mayne Pharma Pty Ltd

Fluconazole
Capsule 50 mg
Oral
28
5
DBL Fluconazole

 
 
 
 
 
Diflucan

 
 
 
 
 
Dizole 50

 
 
 
 
 
Fluconazole Hexal

 
 
 
 
 
Fluzole 50

 
 
 
 
 
Ozole

 
Capsule 100 mg
Oral
28
5
DBL Fluconazole

 
 
 
 
 
Diflucan

 
 
 
 
 
Dizole 100

 
 
 
 
 
Fluconazole Hexal

 
 
 
 
 
Ozole

 
Capsule 200 mg
Oral
28
5
DBL Fluconazole

 
 
 
 
 
Diflucan

 
 
 
 
 
Dizole 200

 
 
 
 
 
Fluconazole Hexal

 
 
 
 
 
Fluzole 200

 
 
 
 
 
Ozole

 
Solution for I.V. infusion 100 mg in 50 mL vial
Injection
7
..
Diflucan

 
Solution for I.V. infusion 200 mg in 100 mL vial
Injection
7
..
Diflucan

Fludrocortisone
Tablet containing fludrocortisone acetate 100 micrograms
Oral
200
1
Florinef

Fluorometholone
Eye drops 1 mg per mL, 5 mL
Application to the eye
1
5
Flucon
FML Liquifilm

 
Eye drops containing fluorometholone acetate 1 mg per mL, 5 mL
Application to the eye
1
2
Flarex

Fluorouracil
Injection 500 mg in 10 mL
Injection
10
..
Fluorouracil Ebewe
Mayne Pharma Pty Ltd

 
Injection 1000 mg in 20 mL
Injection
5
..
Fluorouracil Ebewe

Fluoxetine
Tablet, dispersible, 20 mg (as hydrochloride)
Oral
28
5
Lovan 20 Tab
Prozac Tab

 
Capsule 20 mg (as hydrochloride)
Oral
28
5
Auscap

 
 
 
 
 
Chem mart Fluoxetine

 
 
 
 
 
Fluohexal

 
 
 
 
 
Fluoxebell

 
 
 
 
 
Fluoxetine 20

 
 
 
 
 
Fluoxetine-DP

 
 
 
 
 
GenRx Fluoxetine

 
 
 
 
 
Lovan

 
 
 
 
 
Prozac 20

 
 
 
 
 
Terry White Chemists Fluoxetine

 
 
 
 
 
Zactin

Flupenthixol Decanoate
Oily I.M. injection 20 mg in 1 mL ampoule
Injection
5
..
Fluanxol Depot

 
Oily I.M. injection 40 mg in 2 mL ampoule
Injection
5
..
Fluanxol Depot

 
Oily I.M. injection 100 mg in 1 mL ampoule
Injection
5
..
Fluanxol Concentrated Depot

Fluphenazine Decanoate
Injection 12.5 mg in 0.5 mL ampoule
Injection
5
..
Modecate

 
Injection 25 mg in 1 mL ampoule
Injection
5
..
Modecate

 
Injection 50 mg in 2 mL ampoule
Injection
5
..
Modecate

Flurbiprofen
Eye drops containing flurbiprofen sodium 300 micrograms per mL, single dose units 0.4 mL, 5
Application to the eye
1
..
Ocufen

Flutamide
Tablet 250 mg
Oral
100
5
Eulexin
Flutamin

Fluticasone
Pressurised inhalation containing fluticasone propionate 50 micrograms per dose, 120 doses (CFC-free formulation)
Inhalation by mouth
1
5
Flixotide Junior

 
Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC-free formulation)
Inhalation by mouth
1
5
Flixotide

 
Pressurised inhalation containing fluticasone propionate 250 micrograms per dose, 120 doses (CFC-free formulation)
Inhalation by mouth
1
1
Flixotide

 
Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms per dose, 60 doses
Inhalation by mouth
1
5
Flixotide Junior Accuhaler

 
Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms per dose, 60 doses
Inhalation by mouth
1
5
Flixotide Accuhaler

 
Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms per dose, 60 doses
Inhalation by mouth
1
1
Flixotide Accuhaler

Fluticasone with Salmeterol
Pressurised inhalation containing fluticasone propionate 50 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)
Inhalation by mouth
1
5
Seretide MDI 50/25

 
Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)
Inhalation by mouth
1
5
Seretide MDI 125/25

 
Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses
Inhalation by mouth
1
5
Seretide Accuhaler 100/50

 
Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses
Inhalation by mouth
1
5
Seretide Accuhaler 250/50

 
Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)
Inhalation by mouth
1
5
Seretide MDI 250/25

 
Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses
Inhalation by mouth
1
5
Seretide Accuhaler 500/50

Fluvastatin
Capsule 20 mg (as sodium)
Oral
28
5
Lescol
Vastin

 
Capsule 40 mg (as sodium)
Oral
28
5
Lescol
Vastin

 
Tablet (prolonged release) 80 mg (as sodium)
Oral
28
5
Lescol XL

Fluvoxamine
Tablet containing fluvoxamine maleate 50 mg
Oral
30
5
Faverin 50

 
 
 
 
 
Luvox

 
 
 
 
 
Movox 50

 
 
 
 
 
Voxam

 
Tablet containing fluvoxamine maleate 100 mg
Oral
30
5
Faverin 100

 
 
 
 
 
Luvox

 
 
 
 
 
Movox 100

 
 
 
 
 
Voxam

Folic Acid
Tablet 500 micrograms
Oral
200
..
Megafol 0.5

 
Tablet 5 mg
Oral
200
1
Megafol 5

Follitropin Alfa
Injection set containing 1 vial powder for injection 75 I.U. and 1 pre-filled syringe solvent 1 mL
Injection
5
5
Gonal-f 75

 
Injection set containing 10 vials powder for injection 75 I.U. and 10 pre-filled syringes solvent 1 mL
Injection
1
5
Gonal-f 75

 
Injection 300 I.U. in 0.5 mL multi-dose cartridge
Injection
3
5
Gonal-f Pen

 
Injection set containing 1 vial powder for injection 450 I.U. and 1 pre-filled syringe solvent 1 mL
Injection
3
5
Gonal-f

 
Injection 450 I.U. in 0.75 mL multi-dose cartridge
Injection
3
5
Gonal-f Pen

 
Injection 900 I.U. in 1.5 mL multi-dose cartridge
Injection
2
5
Gonal-f Pen

 
Injection set containing 1 vial powder for injection 1,050 I.U. and 1 pre-filled syringe solvent 2 mL
Injection
1
5
Gonal-f

Follitropin Beta
Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge
Injection
3
5
Puregon 300 IU/0.36 mL

 
Solution for injection 600 I.U. in 0.72 mL multi-dose cartridge
Injection
2
5
Puregon 600 IU/0.72 mL

 
Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge
Injection
2
5
Puregon 900 IU/1.08 mL

Fondaparinux
Injection containing fondaparinux sodium 2.5 mg in 0.5 mL single dose pre-filled syringe
Injection
7
..
Arixtra

Fosinopril
Tablet containing fosinopril sodium 10 mg
Oral
30
5
Fosinopril Sandoz

 
 
 
 
 
Fosipril 10

 
 
 
 
 
GenRx Fosinopril

 
 
 
 
 
Monace 10

 
 
 
 
 
Monopril

 
Tablet containing fosinopril sodium 20 mg
Oral
30
5
Fosinopril Sandoz

 
 
 
 
 
Fosipril 20

 
 
 
 
 
GenRx Fosinopril

 
 
 
 
 
Monace 20

 
 
 
 
 
Monopril

Fosinopril with Hydrochlorothiazide
Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg
Oral
30
5
Fosinopril/HCT Sandoz 10mg/12.5mg
Monoplus 10/12.5

 
Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg
Oral
30
5
Fosinopril/HCT Sandoz 20mg/12.5mg
Monoplus 20/12.5

Fotemustine
Powder for injection 208 mg with solvent
Injection
1
4
Muphoran

Framycetin
Eye or ear drops containing framycetin sulfate 5 mg per mL, 8 mL
Application to the eye/ear
1
2
Soframycin

Frusemide
Tablet 20 mg
Oral
100
1
Chem mart Frusemide

 
 
 
 
 
Frusid

 
 
 
 
 
GenRx Frusemide

 
 
 
 
 
Lasix-M

 
 
 
 
 
Terry White Chemists Frusemide

 
 
 
 
 
Urex-M

 
Tablet 40 mg
Oral
100
1
Chem mart Frusemide

 
 
 
 
 
Frusehexal 40 mg

 
 
 
 
 
Frusid

 
 
 
 
 
GenRx Frusemide

 
 
 
 
 
Lasix

 
 
 
 
 
Terry White Chemists Frusemide

 
 
 
 
 
Uremide

 
 
 
 
 
Urex

 
Tablet 500 mg
Oral
50
3
Urex-Forte

 
Oral solution 10 mg per mL, 30 mL
Oral
1
3
Lasix

 
Injection 20 mg in 2 mL
Injection
5
..
Frusehexal
Lasix

Fusidic Acid
Tablet containing sodium fusidate 250 mg
Oral
36
1
Fucidin

Gabapentin
Capsule 100 mg
Oral
100
5
DBL Gabapentin

 
 
 
 
 
Gantin

 
 
 
 
 
Neurontin

 
 
 
 
 
Nupentin 100

 
Capsule 300 mg
Oral
100
5
DBL Gabapentin

 
 
 
 
 
Douglas Gabapentin 300mg

 
 
 
 
 
Gabahexal 300mg

 
 
 
 
 
Gabapentin 300

 
 
 
 
 
Gantin

 
 
 
 
 
GenRx Gabapentin

 
 
 
 
 
Neurontin

 
 
 
 
 
Nupentin 300

 
 
 
 
 
Pendine 300

 
Capsule 400 mg
Oral
100
5
DBL Gabapentin

 
 
 
 
 
Douglas Gabapentin 400mg

 
 
 
 
 
Gabahexal 400mg

 
 
 
 
 
Gabapentin 400

 
 
 
 
 
Gantin

 
 
 
 
 
GenRx Gabapentin

 
 
 
 
 
Neurontin

 
 
 
 
 
Nupentin 400

 
 
 
 
 
Pendine 400

 
Tablet 600 mg
Oral
100
5
Gabaran
Neurontin

 
Tablet 800 mg
Oral
100
5
Gabaran

 
 
 
 
 
Gantin

 
 
 
 
 
Neurontin

 
 
 
 
 
Pendine 800

Galantamine
Capsule (prolonged release) 8 mg (as hydrobromide)
Oral
28
5
Reminyl

 
Capsule (prolonged release) 16 mg (as hydrobromide)
Oral
28
5
Reminyl

 
Capsule (prolonged release) 24 mg (as hydrobromide)
Oral
28
5
Reminyl

Gefitinib
Tablet 250 mg
Oral
30
1
Iressa

Gelatin - Succinylated
I.V. infusion 20 g per 500 mL, 500 mL
Injection
3
..
Gelofusine

Gemcitabine
Powder for I.V. infusion 200 mg (as hydrochloride)
Injection
4
2
Gemzar

 
Powder for I.V. infusion 1 g (as hydrochloride)
Injection
2
2
Gemzar

Gemfibrozil
Tablet 600 mg
Oral
60
5
Ausgem

 
 
 
 
 
Chem mart Gemfibrozil

 
 
 
 
 
Gemhexal

 
 
 
 
 
GenRx Gemfibrozil

 
 
 
 
 
Jezil

 
 
 
 
 
Lipazil 600 mg

 
 
 
 
 
Lopid

 
 
 
 
 
Terry White Chemists Gemfibrozil

Gentamicin
Injection 80 mg (as sulfate) in 2 mL
Injection
10
1
Mayne Pharma Pty Ltd
Pfizer Pty Limited

 
Eye drops 3 mg (as sulfate) per mL, 5 mL
Application to the eye
1
2
Genoptic

Gestrinone
Capsule 2.5 mg
Oral
8
5
Dimetriose

Glatiramer
Injection containing glatiramer acetate 20 mg in 1 mL single dose pre-filled syringe
Injection
28
5
Copaxone

Glibenclamide
Tablet 5 mg
Oral
100
5
Daonil
Glimel

Gliclazide
Tablet 30 mg (modified release)
Oral
100
5
Diamicron MR
Oziclide MR

 
Tablet 80 mg
Oral
100
5
Chem mart Gliclazide

 
 
 
 
 
Diamicron

 
 
 
 
 
GenRx Gliclazide

 
 
 
 
 
Glyade

 
 
 
 
 
Mellihexal

 
 
 
 
 
Nidem

 
 
 
 
 
Terry White Chemists Gliclazide

Glimepiride
Tablet 1 mg
Oral
30
5
Amaryl

 
 
 
 
 
Aylide 1

 
 
 
 
 
Diapride 1

 
 
 
 
 
Dimirel

 
 
 
 
 
Glimepiride Sandoz

 
Tablet 2 mg
Oral
30
5
Amaryl

 
 
 
 
 
Aylide 2

 
 
 
 
 
Diapride 2

 
 
 
 
 
Dimirel

 
 
 
 
 
Glimepiride Sandoz

 
Tablet 3 mg
Oral
30
5
Amaryl

 
 
 
 
 
Aylide 3

 
 
 
 
 
Diapride 3

 
 
 
 
 
Dimirel

 
 
 
 
 
Glimepiride Sandoz

 
Tablet 4 mg
Oral
30
5
Amaryl

 
 
 
 
 
Aylide 4

 
 
 
 
 
Diapride 4

 
 
 
 
 
Dimirel

 
 
 
 
 
Glimepiride Sandoz

Glipizide
Tablet 5 mg
Oral
100
5
Melizide
Minidiab

Glucagon
Injection set containing glucagon hydrochloride 1 mg (1 I.U.) and 1 mL solvent in disposable syringe
Injection
1
1
GlucaGen Hypokit

Glucose
I.V. infusion 278 mmol (anhydrous) per L, 1 L
Injection
5
1
Baxter Healthcare Pty Limited

Glucose and Ketone Indicator—Urine
Reagent strips, 50 (Keto-Diabur-Test 5000)
For external use 
2
2
Keto-Diabur- Test 5000

 
Reagent strips, 50 (Keto-Diastix)
For external use  
2
2
Keto-Diastix

Glucose Indicator—Blood
Electrode strips, 50 (Accu-Chek Performa)
For external use   
2
5
Accu-Chek Performa

 
Electrode strips, 50 (Advantage II)
For external use   
2
5
Advantage II

 
Electrode strips, 50 (Ascensia Elite)
For external use   
2
5
Ascensia Elite

 
Electrode strips, 50 (Freestyle Papillon)
For external use   
2
5
Freestyle Papillon

 
Electrode strips, 50 (Glucoboy)
For external use   
2
5
Glucoboy

 
Electrode strips, 50 (Glucocard 01 Sensor)
For external use   
2
5
Glucocard 01 Sensor

 
Electrode strips, 50 (GlucoCare)
For external use   
2
5
GlucoCare

 
Electrode strips, 50 (GlucoCare Super Sensor)
For external use   
2
5
GlucoCare Super Sensor

 
Electrode strips, 50 (GlucoMen Sensor)
For external use   
2
5
GlucoMen Sensor

 
Electrode strips, 50 (MWD Pen Sensor Strips)
For external use   
2
5
MWD Pen Sensor Strips

 
Electrode strips, 50 (Omnitest EZ)
For external use   
2
5
Omnitest EZ

 
Electrode strips, 50 (Omnitest Plus)
For external use   
2
5
Omnitest Plus

 
Electrode strips, 50 (Touch-In Plus)
For external use   
2
5
Touch-In Plus

 
Electrode strips, 50 (TrueTrack)
For external use   
2
5
TrueTrack

 
Discs containing electrode sensors, 10 sensors per disc, 5
For external use   
2
5
Ascensia Glucodisc

 
Electrode strips, 100 (Optium glucose)
For external use   
1
5
Optium glucose

 
Electrode strips, 100 (Precision Plus)
For external use   
1
5
Precision Plus

 
Electrode strips, 100 (SofTact)
For external use   
1
5
SofTact

 
Electrode strips, 100 (TrueSense)
For external use   
1
5
TrueSense

 
Reagent strips, 50 (Accu-Chek Active)
For external use   
2
5
Accu-Chek Active

 
Reagent strips, 50 (Accu-Chek Go)
For external use   
2
5
Accu-Chek Go

 
Reagent strips, 51 (Accu-Chek Integra)
For external use   
2
5
Accu-Chek Integra

 
Reagent strips, 50 (Betachek)
For external use   
2
5
Betachek

 
Reagent strips, 50 (Betachek G5)
For external use   
2
5
Betachek G5

 
Reagent strips, 50 (CareSens)
For external use   
2
5
CareSens

 
Reagent strips, 50 (Glucoflex-R)
For external use   
2
5
Glucoflex-R

 
Reagent strips, 50 (Glucostix)
For external use   
2
5
Glucostix

 
Reagent strips, 50 (SensoCard)
For external use   
2
5
SensoCard

Glucose Indicator—Urine
Reagent strips, 50 (Clinistix)
For external use   
2
2
Clinistix

 
Reagent strips, 50 (Diastix)
For external use   
2
2
Diastix

Glycerol
Suppositories 700 mg, 12
Rectal
3
5
Petrus Pharmaceuticals Pty Ltd

 
Suppositories 1.4 g, 12
Rectal
3
5
Petrus Pharmaceuticals Pty Ltd

 
Suppositories 2.8 g, 12
Rectal
3
5
Petrus Pharmaceuticals Pty Ltd

Glyceryl Trinitrate
Tablets 600 micrograms, 100
Buccal/sublingual
1
5
Anginine Stabilised
Lycinate

 
Sublingual spray (pump pack) 400 micrograms per dose, 200 doses
Sublingual
1
5
Nitrolingual Pumpspray

 
Transdermal patch 18 mg
Transdermal
30
5
Minitran 5

 
Transdermal patch 25 mg
Transdermal
30
5
Transiderm-Nitro 25

 
Transdermal patch 40 mg
Transdermal
30
5
Nitro-Dur 5

 
Transdermal patch 36 mg
Transdermal
30
5
Minitran 10

 
Transdermal patch 50 mg
Transdermal
30
5
Transiderm-Nitro 50

 
Transdermal patch 80 mg
Transdermal
30
5
Nitro-Dur 10

 
Transdermal patch 54 mg
Transdermal
30
5
Minitran 15

 
Transdermal patch 120 mg
Transdermal
30
5
Nitro-Dur 15

Goserelin
Subcutaneous implant 3.6 mg (as acetate) in pre-filled injection syringe
Implantation
1
5
Zoladex Implant

 
Subcutaneous implant (long acting) 10.8 mg (as acetate) in pre-filled injection syringe
Implantation
1
1
Zoladex 10.8 Implant

Goserelin and Bicalutamide
Pack containing 1 subcutaneous implant containing goserelin 3.6 mg (as acetate) in pre-filled injection syringe and 28 tablets bicalutamide 50 mg
Implantation/oral
1
5
ZolaCos CP 3.6/50

 
Pack containing 1 subcutaneous implant containing goserelin 10.8 mg (as acetate) in pre-filled injection syringe and 28 tablets bicalutamide 50 mg
Implantation/oral
1
..
ZolaCos CP 10.8/50(28)

 
Pack containing 1 subcutaneous implant containing goserelin 10.8 mg (as acetate) in pre-filled injection syringe and 84 tablets bicalutamide 50 mg
Implantation/oral
1
1
ZolaCos CP 10.8/50(84)

Granisetron
Tablet 2 mg (as hydrochloride)
Oral
2
..
Kytril

 
Concentrated injection 3 mg (as hydrochloride) in 3 mL
Injection
1
..
Kytril

Griseofulvin
Tablet 125 mg
Oral
100
2
Grisovin

 
Tablet 500 mg
Oral
28
2
Grisovin 500

Haloperidol
Tablet 500 micrograms
Oral
100
5
Serenace

 
Tablet 1.5 mg
Oral
100
5
Serenace

 
Tablet 5 mg
Oral
50
5
Serenace

 
Oral solution 2 mg per mL, 100 mL
Oral
1
5
Serenace

 
Injection 5 mg in 1 mL ampoule
Injection
10
..
Serenace

Haloperidol Decanoate
I.M. injection equivalent to 50 mg haloperidol in 1 mL ampoule
Injection
5
..
Haldol decanoate

 
I.M. injection equivalent to 150 mg haloperidol in 3 mL ampoule
Injection
5
..
Haldol decanoate

"HCU express"
Sachets containing oral powder 25 g, 30
Oral
4
5
HCU express

"HCU gel"
Sachets containing oral powder 20 g, 30
Oral
4
5
HCU gel

Heparin
Injection 5,000 units (as sodium) in 0.2 mL
Injection
5
5
Mayne Pharma Pty Ltd

 
Injection (preservative-free) 5,000 I.U. (as sodium) in 5 mL
Injection
50
5
Pfizer Pty Limited

 
Injection 35,000 units (as sodium) in 35 mL
Injection
12
5
Mayne Pharma Pty Ltd

Hexamine
Tablet containing hexamine hippurate 1 g
Oral
100
5
Hiprex

Homatropine
Eye drops containing homatropine hydrobromide 20 mg per mL, 15 mL
Application to the eye
1
2
Isopto Homatropine

Hydralazine
Tablet containing hydralazine hydrochloride 25 mg
Oral
200
2
Alphapress 25

 
Tablet containing hydralazine hydrochloride 50 mg
Oral
200
2
Alphapress 50

Hydrochlorothiazide
Tablet 25 mg
Oral
100
1
Dithiazide

Hydrochlorothiazide with Amiloride
Tablet containing hydrochlorothiazide 50 mg with amiloride hydrochloride 5 mg
Oral
100
1
Amizide
Moduretic

Hydrochlorothiazide with Triamterene
Tablet 25 mg-50 mg
Oral
100
1
Hydrene 25/50

Hydrocortisone
Tablet 4 mg
Oral
50
4
Hysone 4

 
Tablet 20 mg
Oral
60
4
Hysone 20

 
Injection 100 mg (as sodium succinate) with 2 mL solvent
Injection
2
..
Solu-Cortef

 
Injection 250 mg (as sodium succinate) with 2 mL solvent
Injection
1
..
Solu-Cortef

 
Eye ointment containing hydrocortisone acetate 5 mg per g, 5 g
Application to the eye
1
..
Hycor

 
Eye ointment containing hydrocortisone acetate 10 mg per g, 5 g
Application to the eye
1
..
Hycor

 
Cream 10 mg per g, 50 g
Application
1
1
Egocort Cream 1%

 
Cream containing hydrocortisone acetate 10 mg per g, 30 g
Application
1
1
Cortic-DS 1%
Sigmacort

 
Cream containing hydrocortisone acetate 10 mg per g, 50 g
Application
1
1
Cortef
Cortic-DS 1%
Sigmacort

 
Ointment containing hydrocortisone acetate 10 mg per g, 30 g
Application
1
1
Cortic-DS 1%
Sigmacort

 
Ointment containing hydrocortisone acetate 10 mg per g, 50 g
Application
1
1
Cortic-DS 1%
Sigmacort

 
Rectal foam containing hydrocortisone acetate 90 mg per applicatorful, 14 applications, aerosol 21.1 g
Rectal
2
3
Colifoam

Hydromorphone
Tablet containing hydromorphone hydrochloride 2 mg
Oral
20
..
Dilaudid

 
Tablet containing hydromorphone hydrochloride 4 mg
Oral
20
..
Dilaudid

 
Tablet containing hydromorphone hydrochloride 8 mg
Oral
20
..
Dilaudid

 
Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 473 mL
Oral
1
..
Dilaudid

 
Injection containing hydromorphone hydrochloride 2 mg in 1 mL
Injection
5
..
Dilaudid

 
Injection containing hydromorphone hydrochloride 10 mg in 1 mL
Injection
5
..
Dilaudid-HP

 
Injection containing hydromorphone hydrochloride 50 mg in 5 mL
Injection
5
..
Dilaudid-HP

 
Injection containing hydromorphone hydrochloride 500 mg in 50 mL
Injection
1
..
Dilaudid-HP

Hydroxocobalamin
Injection 1 mg (as acetate) in 1 mL
Injection
5
..
Goldshield Hydroxocobalamin

 
Injection 1 mg in 1 mL
Injection
3
..
Neo-B12

Hydroxychloroquine
Tablet containing hydroxychloroquine sulfate 200 mg
Oral
100
1
Plaquenil

Hydroxyurea
Capsule 500 mg
Oral
100
..
Hydrea

Hypromellose
Eye drops 3 mg per mL, 15 mL
Application to the eye
1
5
Genteal
In a Wink Moisturising

 
Eye drops 5 mg per mL, 15 mL
Application to the eye
1
5
Isopto Tears
Methopt

Hypromellose with Carbomer 980
Ocular lubricating gel 3 mg-2 mg per g, 10 g
Application to the eye
1
5
Genteal gel
HPMC PAA

Hypromellose with Dextran
Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL
Application to the eye
1
5
Poly-Tears
Tears Naturale

 
Eye drops containing 3 mg hypromellose 2900 with 1 mg dextran 70 per mL, single dose units 0.4 mL, 28
Application to the eye
3
5
Bion Tears

Ibuprofen
Tablet 200 mg
Oral
100
3
Rafen 200

 
Tablet 400 mg
Oral
30
..
Brufen

Idarubicin
Capsule containing idarubicin hydrochloride 5 mg
Oral
3
..
Zavedos

 
Capsule containing idarubicin hydrochloride 10 mg
Oral
3
..
Zavedos

 
Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL single use vial
Injection
3
..
Zavedos Solution

 
Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL single use vial
Injection
6
..
Zavedos Solution

Ifosfamide
Powder for I.V. injection 1 g in single dose vial
Injection
5
5
Holoxan

 
Powder for I.V. injection 2 g in single dose vial
Injection
5
5
Holoxan

Imipramine
Tablet containing imipramine hydrochloride 10 mg
Oral
50
2
Tofranil 10
Tolerade 10

 
Tablet containing imipramine hydrochloride 25 mg
Oral
50
2
Tofranil 25
Tolerade 25

Imiquimod
Cream 50 mg per g, 250 mg single use sachets, 12
Application
1
1
Aldara

Indapamide
Tablet containing indapamide hemihydrate 1.5 mg (sustained release)
Oral
90
1
Natrilix SR

 
Tablet containing indapamide hemihydrate 2.5 mg
Oral
90
1
Chem mart Indapamide

 
 
 
 
 
Dapa-Tabs

 
 
 
 
 
GenRx Indapamide

 
 
 
 
 
Indahexal

 
 
 
 
 
Insig

 
 
 
 
 
Napamide 2.5 mg

 
 
 
 
 
Natrilix

 
 
 
 
 
Terry White Chemists Indapamide

Indomethacin
Capsule 25 mg
Oral
100
3
Arthrexin
Indocid

 
Suppository 100 mg
Rectal
40
3
Indocid

Influenza Vaccine
Injection containing inactivated, split virion influenza vaccine, 0.5 mL of which contains antigens representative of the following types: A/New Caledonia/20/99 (H1N1)-like strain 15 micrograms haemagglutinin; A/Wisconsin/67/2005 (H3N2)-like strain 15 micrograms haemagglutinin; B/Malaysia/2506/2004-like strain 15 micrograms haemagglutinin; 0.5 mL pre-filled syringe
Injection
1
..
Fluarix
Fluvax
Influvac
Vaxigrip

Insect Allergen Extract—Honey Bee Venom
Injection set containing 550 micrograms vial with 9 mL vial solvent and 3 vials diluent 1.8 mL
Injection
1
..
Albey Bee Venom

Insect Allergen Extract—Paper Wasp Venom
Injection set containing 550 micrograms vial with 9 mL vial solvent and 3 vials diluent 1.8 mL
Injection
1
..
Albey Paper Wasp Venom

Insect Allergen Extract—Yellow Jacket Venom
Injection set containing 550 micrograms vial with 9 mL vial solvent and 3 vials diluent 1.8 mL
Injection
1
..
Albey Yellow Jacket Venom

Insulin Aspart
Injection (human analogue) 100 units per mL, 10 mL vial
Injection
5
2
NovoRapid

 
Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5
Injection
5
1
NovoRapid FlexPen
NovoRapid Penfill 3 mL

Insulin Aspart with Insulin Aspart Protamine Suspension
Injections (human analogue), cartridges, 30 units-70 units per mL, 3 mL, 5
Injection
5
1
NovoMix 30 FlexPen
NovoMix 30 Penfill 3 mL

Insulin Detemir
Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5
Injection
5
1
Levemir FlexPen
Levemir Penfill

Insulin Glargine
Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5
Injection
5
1
Lantus
Lantus SoloStar

Insulin Glulisine
Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5
Injection
5
1
Apidra

Insulin Isophane
Injection (bovine) 100 units per mL, 10 mL
Injection
5
2
Hypurin Isophane

 
Injection (human) 100 units per mL, 10 mL
Injection
5
2
Humulin NPH
Protaphane

 
Injections (human), cartridges, 100 units per mL, 3 mL, 5
Injection
5
1
Humulin NPH

 
 
 
 
 
Protaphane InnoLet

 
 
 
 
 
Protaphane NovoLet 3 mL

 
 
 
 
 
Protaphane Penfill 3 mL

Insulin Lispro
Injection (human analogue) 100 units per mL, 10 mL vial
Injection
5
2
Humalog

 
Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5
Injection
5
1
Humalog

Insulin Lispro with Insulin Lispro Protamine Suspension
Injections (human analogue), cartridges, 25 units-75 units per mL, 3 mL, 5
Injection
5
1
Humalog Mix25

 
Injections (human analogue), cartridges, 50 units-50 units per mL, 3 mL, 5
Injection
5
1
Humalog Mix50

Insulin Neutral
Injection (bovine) 100 units per mL, 10 mL
Injection
5
2
Hypurin Neutral

 
Injection (human) 100 units per mL, 10 mL
Injection
5
2
Actrapid
Humulin R

 
Injections (human), cartridges, 100 units per mL, 3 mL, 5
Injection
5
1
Actrapid Penfill 3 mL
Humulin R

Insulin Neutral with Insulin Isophane
Injection (human) 30 units-70 units per mL, 10 mL
Injection
5
2
Humulin 30/70
Mixtard 30/70

 
Injection (human) 50 units-50 units per mL, 10 mL
Injection
5
2
Mixtard 50/50

 
Injections (human), cartridges, 20 units-80 units per mL, 3 mL, 5
Injection
5
1
Mixtard 20/80 Penfill 3 mL

 
Injections (human), cartridges, 30 units-70 units per mL, 3 mL, 5
Injection
5
1
Humulin 30/70
Mixtard 30/70 InnoLet
Mixtard 30/70 Penfill 3 mL

 
Injections (human), cartridges, 50 units-50 units per mL, 3 mL, 5
Injection
5
1
Mixtard 50/50 Penfill 3 mL

Interferon Alfa-2a
Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe
Injection
15
4
Roferon-A

 
Injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe
Injection
5
4
Roferon-A

 
Injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe
Injection
5
4
Roferon-A

 
Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe
Injection
5
4
Roferon-A

Interferon Alfa-2b
Solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen
Injection
3
4
Intron A Redipen

 
Solution for injection 30,000,000 I.U. in 1.2 mL multi-dose injection pen
Injection
3
5
Intron A Redipen

Interferon Beta-1a
Injection set comprising 1 vial powder for injection 30 micrograms (6,000,000 I.U.) with diluent
Injection
4
5
Avonex

 
Injection 30 micrograms (6,000,000 I.U.) in 0.5 mL single dose pre-filled syringe
Injection
4
5
Avonex

 
Injection 44 micrograms (12,000,000 I.U.) in 0.5 mL single dose pre-filled syringe
Injection
12
5
Rebif 44

Interferon Beta-1b
Injection set comprising 1 vial powder for injection 8,000,000 I.U. (250 micrograms) and solvent
Injection
15
5
Betaferon

Ipratropium
Pressurised inhalation containing ipratropium bromide 21 micrograms per dose, 200 doses (CFC-free formulation)
Inhalation by mouth
2
5
Atrovent

 
Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) in 1 mL single dose units, 30
Inhalation
2
5
Aeron 250
Apoven 250

 
 
 
 
 
Atrovent

 
 
 
 
 
Chem mart Ipratropium

 
 
 
 
 
GenRx Ipratropium

 
 
 
 
 
Ipratrin

 
 
 
 
 
Ipravent

 
 
 
 
 
Terry White Chemists Ipratropium

 
Nebuliser solution containing ipratropium bromide 500 micrograms (anhydrous) in 1 mL single dose units, 30
Inhalation
2
5
Aeron 500
Apoven 500

 
 
 
 
 
Atrovent Adult

 
 
 
 
 
Chem mart Ipratropium

 
 
 
 
 
GenRx Ipratropium

 
 
 
 
 
Ipratrin Adult

 
 
 
 
 
Ipravent

 
 
 
 
 
Terry White Chemists Ipratropium

 
Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) per mL, 20 mL
Inhalation
2
2
Atrovent

Irbesartan
Tablet 75 mg
Oral
30
5
Avapro
Karvea

 
Tablet 150 mg
Oral
30
5
Avapro
Karvea

 
Tablet 300 mg
Oral
30
5
Avapro
Karvea

Irbesartan with Hydrochlorothiazide
Tablet 150 mg-12.5 mg
Oral
30
5
Avapro HCT 150/12.5
Karvezide 150/12.5

 
Tablet 300 mg-12.5 mg
Oral
30
5
Avapro HCT 300/12.5
Karvezide 300/12.5

Irinotecan
I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL
Injection
1
3
Camptosar
Mayne Pharma Pty Ltd

 
I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL
Injection
2
3
Camptosar
Mayne Pharma Pty Ltd

Iron Polymaltose Complex
Injection 100 mg (iron) in 2 mL ampoule
Injection
5
..
Ferrosig
Ferrum H

Iron Sucrose
Concentrate for solution for infusion 2.7 g (equivalent to 100 mg iron (III)) in 5 mL ampoule
Injection
5
..
Venofer

Isoniazid
Tablet 100 mg
Oral
100
2
Fawns and McAllan Pty Ltd

Isosorbide Dinitrate
Tablet 10 mg
Oral
200
2
Isordil
Sorbidin

 
Tablet 5 mg (sublingual)
Oral
200
2
Isordil Sublingual

Isosorbide Mononitrate
Tablet 60 mg (sustained release)
Oral
30
5
Chem mart Isosorbide Mononitrate

 
 
 
 
 
Duride

 
 
 
 
 
GenRx Isosorbide Mononitrate

 
 
 
 
 
Imdur Durule

 
 
 
 
 
Imtrate 60 mg

 
 
 
 
 
Isomonit

 
 
 
 
 
Monodur 60 mg

 
 
 
 
 
Terry White Chemists Isosorbide Mononitrate

 
Tablet 120 mg (sustained release)
Oral
30
5
Imdur 120 mg
Monodur 120 mg

Isotretinoin
Capsule 10 mg
Oral
60
3
GenRx Isotretinoin
Oratane
Roaccutane

 
Capsule 20 mg
Oral
60
3
Chem mart Isotretinoin

 
 
 
 
 
GenRx Isotretinoin

 
 
 
 
 
Isohexal

 
 
 
 
 
Oratane

 
 
 
 
 
Roaccutane

 
 
 
 
 
Terry White Chemists Isotretinoin

 
Capsule 40 mg
Oral
30
3
Oratane

Itraconazole
Capsule 100 mg
Oral
60
5
Sporanox

Ivermectin
Tablet 3 mg
Oral
4
..
Stromectol

"Karicare De-Lact"
Oral powder 900 g
Oral
5
..
Karicare De-Lact

Ketoconazole
Tablet 200 mg
Oral
10
..
Nizoral

 
Cream 20 mg per g, 30 g
Application
1
2
Nizoral 2% Cream

 
Shampoo 10 mg per g, 100 mL
Application
1
1
Nizoral 1%

 
Shampoo 20 mg per g, 60 mL
Application
1
1
Nizoral 2%

"Ketonex-1"
Oral powder 350 g
Oral
8
5
Ketonex-1

"Ketonex-2"
Oral powder 325 g
Oral
10
5
Ketonex-2

Ketoprofen
Capsule 200 mg (sustained release)
Oral
28
3
Orudis SR 200
Oruvail SR

 
Suppository 100 mg
Rectal
40
3
Orudis

"Kindergen"
Oral powder 400 g
Oral
16
5
Kindergen

Labetalol
Tablet containing labetalol hydrochloride 100 mg
Oral
100
5
Presolol 100
Trandate

 
Tablet containing labetalol hydrochloride 200 mg
Oral
100
5
Presolol 200
Trandate

Lactulose
Solution BP 3.34 g per 5 mL, 500 mL
Oral
1
5
Actilax

 
 
 
 
 
Duphalac

 
 
 
 
 
Genlac

 
 
 
 
 
GenRx Lactulose

 
 
 
 
 
Lac-Dol

 
 
 
 
 
Lactocur

Lamotrigine
Tablet 5 mg
Oral
56
5
Elmendos

 
 
 
 
 
Lamictal

 
 
 
 
 
Lamitrin

 
 
 
 
 
Lamogine

 
 
 
 
 
Seaze 5

 
Tablet 25 mg
Oral
56
5
Elmendos

 
 
 
 
 
GenRx Lamotrigine

 
 
 
 
 
Lamictal

 
 
 
 
 
Lamidus

 
 
 
 
 
Lamitrin

 
 
 
 
 
Lamogine

 
 
 
 
 
Lamotrigine-DP

 
 
 
 
 
Seaze 25

 
Tablet 50 mg
Oral
56
5
Elmendos

 
 
 
 
 
GenRx Lamotrigine

 
 
 
 
 
Lamictal

 
 
 
 
 
Lamidus

 
 
 
 
 
Lamitrin

 
 
 
 
 
Lamogine

 
 
 
 
 
Lamotrigine-DP

 
 
 
 
 
Seaze 50

 
Tablet 100 mg
Oral
56
5
Elmendos

 
 
 
 
 
GenRx Lamotrigine

 
 
 
 
 
Lamictal

 
 
 
 
 
Lamidus

 
 
 
 
 
Lamitrin

 
 
 
 
 
Lamogine

 
 
 
 
 
Lamotrigine-DP

 
 
 
 
 
Seaze 100

 
Tablet 200 mg
Oral
56
5
Elmendos

 
 
 
 
 
GenRx Lamotrigine

 
 
 
 
 
Lamictal

 
 
 
 
 
Lamidus

 
 
 
 
 
Lamitrin

 
 
 
 
 
Lamogine

 
 
 
 
 
Lamotrigine-DP

 
 
 
 
 
Seaze 200

Lansoprazole
Capsule 30 mg
Oral
30
1
Zoton

 
Sachet containing granules for oral suspension, 30 mg per sachet
Oral
28
1
Zoton

 
Capsule 15 mg
Oral
30
5
Zoton

Latanoprost
Eye drops 50 micrograms per mL, 2.5 mL
Application to the eye
1
5
Xalatan

Latanoprost with Timolol
Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL
Application to the eye
1
5
Xalacom

Leflunomide
Pack containing 3 tablets leflunomide 100 mg and 30 tablets leflunomide 20 mg
Oral
1
..
Arava

 
Tablet 10 mg
Oral
30
5
Arabloc
Arava

 
Tablet 20 mg
Oral
30
5
Arabloc
Arava

Lercanidipine
Tablet containing lercanidipine hydrochloride 10 mg
Oral
30
5
Zanidip

 
Tablet containing lercanidipine hydrochloride 20 mg
Oral
30
5
Zanidip

Letrozole
Tablet 2.5 mg
Oral
30
5
Femara 2.5 mg

Leuprorelin
I.M. injection (modified release), powder for injection containing leuprorelin acetate 7.5 mg with diluent in pre-filled dual-chamber syringe
Injection
1
5
Lucrin Depot 7.5mg PDS

 
Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 7.5 mg, injection set
Injection
1
5
Eligard 1 month

 
I.M. injection (modified release), powder for injection containing leuprorelin acetate 22.5 mg with diluent in pre-filled dual-chamber syringe
Injection
1
1
Lucrin Depot 3 Month PDS

 
Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 22.5 mg, injection set
Injection
1
1
Eligard 3 month

 
I.M. injection (modified release), powder for injection containing leuprorelin acetate 30 mg with diluent in pre-filled dual-chamber syringe
Injection
1
1
Lucrin Depot 4 Month PDS

 
Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 30 mg, injection set
Injection
1
1
Eligard 4 month

 
Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 45 mg, injection set
Injection
1
..
Eligard 6 month

Levetiracetam
Tablet 250 mg
Oral
60
5
Keppra

 
Tablet 500 mg
Oral
60
5
Keppra

 
Tablet 1 g
Oral
60
5
Keppra

Levobunolol
Eye drops containing levobunolol hydrochloride 2.5 mg    per mL, 5 mL
Application to the eye
1
5
Betagan

Levodopa with Benserazide
Dispersible tablet containing levodopa 50 mg with 12.5 mg benserazide (as hydrochloride)
Oral
100
5
Madopar Rapid 62.5

 
Dispersible tablet containing levodopa 100 mg with 25 mg benserazide (as hydrochloride)
Oral
100
5
Madopar Rapid 125

 
Tablet containing levodopa 100 mg with 25 mg benserazide (as hydrochloride)
Oral
100
5
Madopar 125

 
Tablet containing levodopa 200 mg with 50 mg benserazide (as hydrochloride)
Oral
100
5
Madopar

 
Capsule containing levodopa 50 mg with 12.5 mg benserazide (as hydrochloride)
Oral
100
5
Madopar 62.5

 
Capsule containing levodopa 100 mg with 25 mg benserazide (as hydrochloride)
Oral
100
5
Madopar 125

 
Capsule containing levodopa 100 mg with 25 mg benserazide (as hydrochloride) (sustained release)
Oral
100
5
Madopar HBS

 
Capsule containing levodopa 200 mg with 50 mg benserazide (as hydrochloride)
Oral
100
5
Madopar

Levodopa with Carbidopa
Tablet 200 mg-50 mg (anhydrous) (modified release)
Oral
100
5
Sinemet CR

 
Tablet 100 mg-25 mg (anhydrous)
Oral
100
5
Kinson
Sinemet 100/25

 
Tablet 250 mg-25 mg (anhydrous)
Oral
100
5
Levohexal
Sinemet

Levodopa with Carbidopa and Entacapone
Tablet 50 mg-12.5 mg-200 mg
Oral
200
4
Stalevo 50/12.5/200mg

 
Tablet 100 mg-25 mg-200 mg
Oral
200
4
Stalevo 100/25/200mg

 
Tablet 150 mg-37.5 mg-200 mg
Oral
200
4
Stalevo 150/37.5/200mg

Levonorgestrel
Tablets 30 micrograms, 28
Oral
4
2
Microlut 28
Microval 28

 
Intrauterine drug delivery system 52 mg
Intrauterine
1
..
Mirena

Levonorgestrel with Ethinyloestradiol
Pack containing 21 tablets 125 micrograms-50 micrograms and 7 inert tablets
Oral
4
2
Microgynon 50 ED

 
Tablets 150 micrograms-30 micrograms, 21
Oral
4
2
Microgynon 30

 
Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets
Oral
4
2
Levlen ED
Microgynon 30 ED

 
 
 
 
 
Monofeme 28

 
 
 
 
 
Nordette 28

 
Pack containing 6 tablets 50 micrograms-30 micrograms, 5 tablets 75 micrograms-40 micrograms, 10 tablets 125 micrograms-30 micrograms and 7 inert tablets
Oral
4
2
Logynon ED
Trifeme 28
Triphasil 28

 
 
 
 
 
Triquilar ED

Lignocaine
Injection containing lignocaine hydrochloride 100 mg in 5 mL
Injection
5
..
Pfizer Pty Limited

 
Infusion containing lignocaine hydrochloride 500 mg in 5 mL
Injection
10
..
Xylocard 500

Lincomycin
Injection 600 mg (as hydrochloride) in 2 mL
Injection
5
..
Lincocin

Liothyronine
Tablet containing liothyronine sodium 20 micrograms
Oral
100
2
Tertroxin

Lisinopril
Tablet 5 mg
Oral
30
5
Chem mart Lisinopril

 
 
 
 
 
Fibsol 5

 
 
 
 
 
GenRx Lisinopril

 
 
 
 
 
Liprace

 
 
 
 
 
Lisinobell

 
 
 
 
 
Lisinopril 5

 
 
 
 
 
Lisinopril Hexal

 
 
 
 
 
Lisinopril Winthrop

 
 
 
 
 
Lisodur

 
 
 
 
 
Prinivil 5

 
 
 
 
 
Terry White Chemists Lisinopril

 
 
 
 
 
Zestril

 
Tablet 10 mg
Oral
30
5
Chem mart Lisinopril

 
 
 
 
 
Fibsol 10

 
 
 
 
 
GenRx Lisinopril

 
 
 
 
 
Liprace

 
 
 
 
 
Lisinobell

 
 
 
 
 
Lisinopril 10

 
 
 
 
 
Lisinopril Hexal

 
 
 
 
 
Lisinopril Winthrop

 
 
 
 
 
Lisodur

 
 
 
 
 
Prinivil 10

 
 
 
 
 
Terry White Chemists Lisinopril

 
 
 
 
 
Zestril

 
Tablet 20 mg
Oral
30
5
Chem mart Lisinopril

 
 
 
 
 
Fibsol 20

 
 
 
 
 
GenRx Lisinopril

 
 
 
 
 
Liprace

 
 
 
 
 
Lisinobell

 
 
 
 
 
Lisinopril 20

 
 
 
 
 
Lisinopril Hexal

 
 
 
 
 
Lisinopril Winthrop

 
 
 
 
 
Lisodur

 
 
 
 
 
Prinivil 20

 
 
 
 
 
Terry White Chemists Lisinopril

 
 
 
 
 
Zestril

Lithium
Tablet containing lithium carbonate 250 mg
Oral
200
2
Lithicarb

 
Tablet containing lithium carbonate 450 mg (slow release)
Oral
200
2
Quilonum SR

"Locasol"
Low calcium compound powder 400 g
Oral
8
5
Locasol

Loperamide
Capsule containing loperamide hydrochloride 2 mg
Oral
12
..
Gastro-Stop Loperamide
Imodium

"Lophlex"
Sachets containing oral powder 27.8 g, 30
Oral
3
5
Lophlex

"Lophlex LQ"
Oral liquid 125 mL, 30
Oral
3
5
Lophlex LQ

Lumiracoxib
Tablet 200 mg
Oral
30
3
Prexige

Macrogol 3350
Sachets containing powder for oral solution 13.125 g with electrolytes, 30
Oral
1
5
Movicol

"Mapleflex"
Sachets containing oral powder 29 g, 30
Oral
4
5
Mapleflex

Medroxyprogesterone
Tablet containing medroxyprogesterone acetate 500 mg
Oral
30
2
Provera

 
Tablet containing medroxyprogesterone acetate 100 mg
Oral
100
2
Provera

 
Tablet containing medroxyprogesterone acetate 200 mg
Oral
60
2
Provera

 
Tablet containing medroxyprogesterone acetate 250 mg
Oral
60
2
Provera

 
Tablet containing medroxyprogesterone acetate 5 mg
Oral
56
2
Provera
Ralovera

 
Tablet containing medroxyprogesterone acetate 10 mg
Oral
30
2
Medroxyhexal
Provera
Ralovera

 
Injection containing medroxyprogesterone acetate 50 mg in 1 mL
Injection
1
1
Depo-Provera

 
Injection containing medroxyprogesterone acetate 150 mg in 1 mL
Injection
1
1
Depo-Provera
Depo-Ralovera

Mefenamic Acid
Capsule 250 mg
Oral
50
2
Ponstan

Megestrol
Tablet containing megestrol acetate 160 mg
Oral
30
2
Megace

Meloxicam
Tablet 7.5 mg
Oral
30
3
Chem mart Meloxicam 7.5 mg

 
 
 
 
 
GenRx Meloxicam

 
 
 
 
 
Mobic

 
 
 
 
 
Movalis 7.5

 
 
 
 
 
Moxicam 7.5

 
 
 
 
 
Terry White Chemists Meloxicam 7.5 mg

 
Tablet 15 mg
Oral
30
3
Chem mart Meloxicam 15 mg

 
 
 
 
 
GenRx Meloxicam

 
 
 
 
 
Mobic

 
 
 
 
 
Movalis 15

 
 
 
 
 
Moxicam 15

 
 
 
 
 
Terry White Chemists Meloxicam 15 mg

 
Capsule 7.5 mg
Oral
30
3
Mobic

 
Capsule 15 mg
Oral
30
3
Mobic

Melphalan
Tablet 2 mg
Oral
25
1
Alkeran

Mercaptopurine
Tablet 50 mg
Oral
100
2
Purinethol

Mesalazine
Tablet 250 mg (enteric coated)
Oral
100
5
Mesasal

 
Tablet 500 mg (enteric coated)
Oral
100
5
Salofalk

 
Tablet 500 mg (prolonged release)
Oral
100
5
Pentasa

 
Sachet containing prolonged release granules, 1 g per sachet
Oral
100
5
Pentasa

 
Sachet containing prolonged release granules, 2 g per sachet
Oral
60
5
Pentasa

 
Sachet containing granules, 500 mg per sachet
Oral
100
5
Salofalk

 
Sachet containing granules, 1 g per sachet
Oral
100
2
Salofalk

 
Suppositories 1 g, 28
Rectal
1
..
Pentasa

 
Enemas 1 g in 100 mL, 7
Rectal
4
..
Pentasa

 
Enemas 2 g in 60 mL, 7
Rectal
4
..
Salofalk

 
Enemas 4 g in 60 mL, 7
Rectal
4
..
Salofalk

 
Rectal foam 1 g per applicatorful, 14 applications, aerosol 80 g
Rectal
4
..
Salofalk

Mesna
Solution for I.V. injection 400 mg in 4 mL ampoule
Injection
15
5
Uromitexan

 
Solution for I.V. injection 1 g in 10 mL ampoule
Injection
15
5
Uromitexan

"Metabolic Mineral Mixture"
Oral powder 250 g
Oral
1
5
Metabolic Mineral Mixture

Metformin
Tablet containing metformin hydrochloride 500 mg
Oral
100
5
Chem mart Metformin

 
 
 
 
 
Diabex

 
 
 
 
 
Diaformin

 
 
 
 
 
Formet 500

 
 
 
 
 
GenRx Metformin

 
 
 
 
 
Glucohexal

 
 
 
 
 
Glucomet 500 mg

 
 
 
 
 
Glucophage

 
 
 
 
 
Genepharm Australasia Limited

 
 
 
 
 
Metforbell

 
 
 
 
 
Metformin 500

 
 
 
 
 
Terry White Chemists Metformin

 
Tablet containing metformin hydrochloride 500 mg (extended release)
Oral
90
5
Diabex XR

 
Tablet containing metformin hydrochloride 850 mg
Oral
60
5
Chem mart Metformin

 
 
 
 
 
Diabex 850

 
 
 
 
 
Diaformin 850

 
 
 
 
 
Formet 850

 
 
 
 
 
GenRx Metformin

 
 
 
 
 
Glucohexal

 
 
 
 
 
Glucomet 850 mg

 
 
 
 
 
Glucophage

 
 
 
 
 
Genepharm Australasia Limited

 
 
 
 
 
Metforbell

 
 
 
 
 
Metformin 850

 
 
 
 
 
Terry White Chemists Metformin

 
Tablet containing metformin hydrochloride 1 g
Oral
90
5
Diabex 1000
Diaformin 1000
Formet 1000

Metformin with Glibenclamide
Tablet containing metformin hydrochloride 250 mg with glibenclamide 1.25 mg
Oral
90
5
Glucovance 250mg/1.25mg

 
Tablet containing metformin hydrochloride 500 mg with glibenclamide 2.5 mg
Oral
90
5
Glucovance 500mg/2.5mg

 
Tablet containing metformin hydrochloride 500 mg with glibenclamide 5 mg
Oral
90
5
Glucovance 500mg/5mg

Methadone
Tablet containing methadone hydrochloride 10 mg
Oral
20
..
Physeptone

 
Injection containing methadone hydrochloride 10 mg in 1 mL
Injection
5
..
Physeptone

Methotrexate
Tablet 2.5 mg
Oral
30
5
Methoblastin
Mayne Pharma Pty Ltd

 
Tablet 10 mg
Oral
50
2
Methoblastin

 
Injection 5 mg in 2 mL vial
Injection
5
..
Mayne Pharma Pty Ltd

 
Injection 50 mg in 2 mL vial
Injection
5
..
Mayne Pharma Pty Ltd
Pfizer Pty Limited

 
Solution concentrate for I.V. infusion 500 mg in 5 mL vial
Injection
1
..
Methotrexate Ebewe

 
Solution concentrate for I.V. infusion 500 mg in 20 mL vial
Injection
1
..
Mayne Pharma Pty Ltd

 
Solution concentrate for I.V. infusion 1000 mg in 10 mL vial
Injection
1
..
Methotrexate Ebewe
Mayne Pharma Pty Ltd

 
Solution concentrate for I.V. infusion 5000 mg in 50 mL vial
Injection
1
..
Methotrexate Ebewe

Methyldopa
Tablet 250 mg
Oral
100
5
Aldomet
Hydopa

Methylphenidate
Tablet containing methylphenidate hydrochloride 10 mg
Oral
100
5
Attenta
Ritalin 10

 
Tablet containing methylphenidate hydrochloride 18 mg (extended release)
Oral
30
5
Concerta

 
Tablet containing methylphenidate hydrochloride 27 mg (extended release)
Oral
30
5
Concerta

 
Tablet containing methylphenidate hydrochloride 36 mg (extended release)
Oral
30
5
Concerta

 
Tablet containing methylphenidate hydrochloride 54 mg (extended release)
Oral
30
5
Concerta

Methylprednisolone
Injection containing methylprednisolone acetate 40 mg in 1 mL
Injection
5
..
Depo-Medrol
Depo-Nisolone

 
Powder for injection 40 mg (as sodium succinate) with diluent
Injection
5
..
Solu-Medrol

 
Powder for injection 1 g (as sodium succinate) with diluent
Injection
1
..
Solu-Medrol

 
Cream containing methylprednisolone aceponate 1 mg per g, 15 g
Application
1
..
Advantan

 
Ointment containing methylprednisolone aceponate 1 mg per g, 15 g
Application
1
..
Advantan

 
Fatty ointment containing methylprednisolone aceponate 1 mg per g, 15 g
Application
1
..
Advantan

 
Lotion containing methylprednisolone aceponate 1 mg per g, 20 g
Application
1
..
Advantan

Methysergide
Tablet 1 mg (as maleate)
Oral
100
2
Deseril

Metoclopramide
Tablet containing metoclopramide hydrochloride 10 mg
Oral
25
..
Maxolon
Pramin

 
Injection containing metoclopramide hydrochloride 10 mg in 2 mL
Injection
10
..
Maxolon

Metoprolol
Pack containing 15 tablets metoprolol succinate 23.75 mg (controlled release), 15 tablets metoprolol succinate 47.5 mg (controlled release) and 15 tablets metoprolol succinate 95 mg (controlled release)
Oral
1
..
Toprol-XL Titration Pack

 
Tablet containing metoprolol succinate 23.75 mg (controlled release)
Oral
15
..
Toprol-XL 23.75

 
Tablet containing metoprolol tartrate 50 mg
Oral
100
5
Betaloc

 
 
 
 
 
Chem mart Metoprolol

 
 
 
 
 
GenRx Metoprolol

 
 
 
 
 
Lopresor 50

 
 
 
 
 
Metohexal

 
 
 
 
 
Metolol

 
 
 
 
 
Metrol 50

 
 
 
 
 
Minax 50

 
 
 
 
 
Terry White Chemists Metoprolol

 
Tablet containing metoprolol succinate 47.5 mg (controlled release)
Oral
30
5
Toprol-XL 47.5

 
Tablet containing metoprolol tartrate 100 mg
Oral
60
5
Betaloc

 
 
 
 
 
Chem mart Metoprolol

 
 
 
 
 
GenRx Metoprolol

 
 
 
 
 
Lopresor 100

 
 
 
 
 
Metohexal

 
 
 
 
 
Metolol

 
 
 
 
 
Metrol 100

 
 
 
 
 
Minax 100

 
 
 
 
 
Terry White Chemists Metoprolol

 
Tablet containing metoprolol succinate 95 mg (controlled release)
Oral
30
5
Toprol-XL 95

 
Tablet containing metoprolol succinate 190 mg (controlled release)
Oral
30
5
Toprol-XL 190

Metronidazole
Tablet 200 mg
Oral
21
1
Flagyl
Metrogyl 200
Metronide 200

 
Tablet 400 mg
Oral
5
2
Metrogyl 400

 
Oral suspension containing metronidazole benzoate 320 mg per 5 mL, 100 mL
Oral
1
..
Flagyl S

 
I.V. infusion 500 mg in 100 mL
Injection
5
1
Baxter Healthcare Pty Limited

 
Suppositories 500 mg, 10
Rectal
1
..
Flagyl

Mexiletine
Capsule containing mexiletine hydrochloride 50 mg
Oral
100
5
Mexitil

 
Capsule containing mexiletine hydrochloride 200 mg
Oral
100
5
Mexitil

Mianserin
Tablet containing mianserin hydrochloride 10 mg
Oral
50
5
Lumin 10
Tolvon

 
Tablet containing mianserin hydrochloride 20 mg
Oral
50
5
Lumin 20
Tolvon

Miconazole
Cream containing miconazole nitrate 20 mg per g, 15 g
Application
2
3
Daktarin

 
Cream containing miconazole nitrate 20 mg per g, 30 g
Application
1
2
Daktarin

 
Cream containing miconazole nitrate 20 mg per g, 70 g
Application
1
1
Daktarin

 
Powder containing miconazole nitrate 20 mg per g, 30 g
Application
1
2
Daktarin

 
Tincture 20 mg per mL, 30 mL
Application
1
2
Daktarin

 
Lotion containing miconazole nitrate 20 mg per mL, 30 g
Application
1
2
Daktarin

"Minaphlex"
Sachets containing oral powder 29 g, 30
Oral
4
5
Minaphlex

Minocycline
Tablet 50 mg (as hydrochloride)
Oral
60
5
Akamin 50
Minomycin-50

 
Capsule 100 mg (as hydrochloride)
Oral
11
..
Akamin 100

Minoxidil
Tablet 10 mg
Oral
100
5
Loniten

Mirtazapine
Tablet 15 mg (orally disintegrating)
Oral
30
5
Avanza SolTab

 
Tablet 30 mg
Oral
30
5
Avanza

 
 
 
 
 
Axit 30

 
 
 
 
 
Mirtazapine-DP

 
 
 
 
 
Mirtazapine Sandoz

 
 
 
 
 
Mirtazon

 
 
 
 
 
Remeron

 
Tablet 30 mg (orally disintegrating)
Oral
30
5
Avanza SolTab

 
Tablet 45 mg
Oral
30
5
Avanza
Mirtazapine Sandoz
Mirtazon

 
Tablet 45 mg (orally disintegrating)
Oral
30
5
Avanza SolTab

Misoprostol
Tablet 200 micrograms
Oral
120
2
Cytotec

Mitozantrone
Injection 10 mg (as hydrochloride) in 5 mL
Injection
1
..
Mitozantrone Ebewe
Pfizer Pty Limited

 
Injection 20 mg (as hydrochloride) in 10 mL
Injection
1
..
Mitozantrone Ebewe

 
 
 
 
 
Mayne Pharma Pty Ltd

 
 
 
 
 
Onkotrone

 
 
 
 
 
Pfizer Pty Limited

 
Injection 25 mg (as hydrochloride) in 12.5 mL
Injection
1
..
Onkotrone
Pfizer Pty Limited

Moclobemide
Tablet 150 mg
Oral
60
5
Amira 150

 
 
 
 
 
Arima

 
 
 
 
 
Aurorix

 
 
 
 
 
Chem mart Moclobemide

 
 
 
 
 
Clobemix

 
 
 
 
 
GenRx Moclobemide

 
 
 
 
 
Mohexal

 
 
 
 
 
Terry White Chemists Moclobemide

 
Tablet 300 mg
Oral
60
5
Amira 300

 
 
 
 
 
Arima 300

 
 
 
 
 
Aurorix 300 mg

 
 
 
 
 
Chem mart Moclobemide

 
 
 
 
 
Clobemix

 
 
 
 
 
GenRx Moclobemide

 
 
 
 
 
Maosig

 
 
 
 
 
Mohexal

 
 
 
 
 
Terry White Chemists Moclobemide

Modafinil
Tablet 100 mg
Oral
120
5
Modavigil

Mometasone
Cream containing mometasone furoate 1 mg per g, 15 g
Application
1
..
Elocon
Novasone

 
Ointment containing mometasone furoate 1 mg per g, 15 g
Application
1
..
Elocon
Novasone

 
Lotion containing mometasone furoate 1 mg per g, 30 mL
Application
1
..
Elocon
Novasone

"Monogen"
Oral powder 400 g
Oral
8
5
Monogen

Montelukast
Tablet, chewable, 4 mg (as sodium)
Oral
28
5
Singulair

 
Tablet, chewable, 5 mg (as sodium)
Oral
28
5
Singulair

Morphine
Tablet containing morphine sulfate 10 mg
Oral
20
..
Sevredol

 
Tablet containing morphine sulfate 20 mg
Oral
20
..
Sevredol

 
Tablet containing morphine sulfate 30 mg
Oral
20
..
Anamorph

 
Tablet containing morphine sulfate 5 mg (controlled release)
Oral
20
..
MS Contin

 
Tablet containing morphine sulfate 10 mg (controlled release)
Oral
20
..
MS Contin

 
Tablet containing morphine sulfate 15 mg (controlled release)
Oral
20
..
MS Contin

 
Tablet containing morphine sulfate 30 mg (controlled release)
Oral
20
..
MS Contin

 
Tablet containing morphine sulfate 60 mg (controlled release)
Oral
20
..
MS Contin

 
Tablet containing morphine sulfate 100 mg (controlled release)
Oral
20
..
MS Contin

 
Tablet containing morphine sulfate 200 mg (controlled release)
Oral
20
..
MS Contin

 
Capsule containing morphine sulfate 10 mg (containing sustained release pellets)
Oral
20
..
Kapanol

 
Capsule containing morphine sulfate 20 mg (containing sustained release pellets)
Oral
20
..
Kapanol

 
Capsule containing morphine sulfate 30 mg (controlled release)
Oral
10
..
MS Mono

 
Capsule containing morphine sulfate 50 mg (containing sustained release pellets)
Oral
20
..
Kapanol

 
Capsule containing morphine sulfate 60 mg (controlled release)
Oral
10
..
MS Mono

 
Capsule containing morphine sulfate 90 mg (controlled release)
Oral
10
..
MS Mono

 
Capsule containing morphine sulfate 100 mg (containing sustained release pellets)
Oral
20
..
Kapanol

 
Capsule containing morphine sulfate 120 mg (controlled release)
Oral
10
..
MS Mono

 
Sachet containing controlled release granules for oral suspension, containing morphine sulfate 20 mg per sachet
Oral
20
..
MS Contin Suspension 20 mg

 
Sachet containing controlled release granules for oral suspension, containing morphine sulfate 30 mg per sachet
Oral
20
..
MS Contin Suspension 30 mg

 
Sachet containing controlled release granules for oral suspension, containing morphine sulfate 60 mg per sachet
Oral
20
..
MS Contin Suspension 60 mg

 
Sachet containing controlled release granules for oral suspension, containing morphine sulfate 100 mg per sachet
Oral
20
..
MS Contin Suspension 100 mg

 
Sachet containing controlled release granules for oral suspension, containing morphine sulfate 200 mg per sachet
Oral
20
..
MS Contin Suspension 200 mg

 
Oral solution containing morphine hydrochloride 2 mg per mL, 200 mL
Oral
1
..
Ordine 2

 
Oral solution containing morphine hydrochloride 5 mg per mL, 200 mL
Oral
1
..
Ordine 5

 
Oral solution containing morphine hydrochloride 10 mg per mL, 200 mL
Oral
1
..
Ordine 10

 
Injection containing morphine sulfate 10 mg in 1 mL
Injection
5
..
Mayne Pharma Pty Ltd

 
Injection containing morphine tartrate 120 mg in 1.5 mL
Injection
5
..
Mayne Pharma Pty Ltd

 
Injection containing morphine sulfate 15 mg in 1 mL
Injection
5
..
Mayne Pharma Pty Ltd

 
Injection containing morphine sulfate 30 mg in 1 mL
Injection
5
..
Mayne Pharma Pty Ltd

Moxonidine
Tablet 200 micrograms
Oral
30
5
Physiotens

 
Tablet 400 micrograms
Oral
30
5
Physiotens

"MSUD AID III"
Oral powder 500 g
Oral
4
5
MSUD AID III

"MSUD Analog"
Oral powder 400 g
Oral
8
5
MSUD Analog

"MSUD Express"
Sachets containing oral powder 25 g, 30
Oral
4
5
MSUD Express

"MSUD Express Cooler"
Oral liquid 130 mL, 30
Oral
4
5
MSUD Express Cooler

"MSUD-gel"
Sachets containing oral powder 20 g, 30
Oral
4
5
MSUD-gel

"MSUD Maxamaid"
Oral powder 500 g
Oral
8
5
MSUD Maxamaid

"MSUD Maxamum"
Oral powder 500 g
Oral
8
5
MSUD Maxamum

Mycophenolic Acid
Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid
Oral
120
3
Myfortic

 
Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid
Oral
120
3
Myfortic

 
Capsule containing mycophenolate mofetil 250 mg
Oral
300
3
CellCept

 
Tablet containing mycophenolate mofetil 500 mg
Oral
150
3
CellCept

 
Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL
Oral
1
3
CellCept

Nafarelin
Nasal spray (pump pack) 200 micrograms (as acetate) per dose, 60 doses
Nasal
1
5
Synarel

Naloxone
Injection containing naloxone hydrochloride 800 micrograms in 2 mL disposable injection set
Injection
1
..
Naloxone Min-I-Jet

 
Injection containing naloxone hydrochloride 2 mg in 5 mL disposable injection set
Injection
1
..
Naloxone Min-I-Jet

Naltrexone
Tablet containing naltrexone hydrochloride 50 mg
Oral
30
1
ReVia

Nandrolone Decanoate
Injection 50 mg in 1 mL disposable syringe
Injection
1
7
Deca-Durabolin

Naproxen
Tablet 250 mg
Oral
100
3
Inza 250
Naprosyn

 
Tablet containing naproxen sodium 550 mg
Oral
50
3
Anaprox 550
Crysanal

 
Tablet 500 mg
Oral
50
3
Inza 500
Naprosyn

 
Tablet 750 mg (sustained release)
Oral
28
3
Naprosyn SR750
Proxen SR 750

 
Tablet 1 g (sustained release)
Oral
28
3
Naprosyn SR1000
Proxen SR 1000

 
Oral suspension 125 mg per 5 mL, 474 mL
Oral
1
3
Naprosyn

Naratriptan
Tablet 2.5 mg (as hydrochloride)
Oral
4
5
Naramig

Nedocromil
Pressurised inhalation containing nedocromil sodium 2 mg per dose, 112 doses (CFC-free formulation)
Inhalation by mouth
1
5
Tilade CFC-Free

"Neocate"
Oral powder 400 g
Oral
8
5
Neocate

"Neocate Advance"
Oral powder 400 g
Oral
8
5
Neocate Advance

"Neocate Advance Tropical Flavour"
Oral powder 400 g
Oral
8
5
Neocate Advance Tropical Flavour

"Neocate LCP"
Oral powder 400 g
Oral
8
5
Neocate LCP

Neomycin
Tablet containing neomycin sulfate 500 mg
Oral
25
1
Neosulf

Neomycin with Bacitracin
Ear ointment 3.5 mg neomycin (as undecenoate) with bacitracin zinc 400 units per g, 10 g
Application to the ear
1
..
Nemdyn

Nicorandil
Tablets 10 mg, 60
Oral
1
5
Ikorel

 
Tablets 20 mg, 60
Oral
1
5
Ikorel

Nifedipine
Tablet 10 mg
Oral
60
5
Adalat 10
Adefin 10
Nypine 10

 
Tablet 20 mg
Oral
60
5
Adalat 20

 
 
 
 
 
Adefin 20

 
 
 
 
 
Chem mart Nifedipine

 
 
 
 
 
GenRx Nifedipine

 
 
 
 
 
Nifehexal

 
 
 
 
 
Nyefax 20 mg

 
 
 
 
 
Nypine 20

 
 
 
 
 
Terry White Chemists Nifedipine

 
Tablet 20 mg (controlled release)
Oral
30
5
Adalat Oros 20mg

 
Tablet 30 mg (controlled release)
Oral
30
5
Adalat Oros 30
Addos XR 30
Adefin XL 30

 
Tablet 60 mg (controlled release)
Oral
30
5
Adalat Oros 60
Addos XR 60
Adefin XL 60

Nilutamide
Tablet 150 mg
Oral
30
5
Anandron

Nitrazepam
Tablet 5 mg
Oral
25
..
Alodorm
Mogadon

Nitrofurantoin
Capsule 50 mg
Oral
30
1
Macrodantin

 
Capsule 100 mg
Oral
30
1
Macrodantin

Nizatidine
Capsule 150 mg
Oral
60
5
Nizac
Tacidine
Tazac

 
Capsule 300 mg
Oral
30
5
Nizac
Tacidine
Tazac

Norethisterone
Tablets 350 micrograms, 28
Oral
4
2
Locilan 28 Day
Micronor
Noriday 28 Day

 
Tablet 5 mg
Oral
30
2
Primolut N

Norethisterone with Ethinyloestradiol
Tablets 500 micrograms-35 micrograms, 21
Oral
4
2
Brevinor

 
Pack containing 21 tablets 500 micrograms-35 micrograms and 7 inert tablets
Oral
4
2
Brevinor
Norimin 28 Day

 
Tablets 1 mg-35 micrograms, 21
Oral
4
2
Brevinor-1

 
Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets
Oral
4
2
Brevinor-1
Norimin-1 28 Day

 
Pack containing 12 tablets 500 micrograms-35 micrograms, 9 tablets 1 mg-35 micrograms and 7 inert tablets
Oral
4
2
Improvil 28 Day
Synphasic

Norethisterone with Mestranol
Tablets 1 mg-50 micrograms, 21
Oral
4
2
Norinyl-1

 
Pack containing 21 tablets 1 mg-50 micrograms and 7 inert tablets
Oral
4
2
Norinyl-1/28

Norfloxacin
Tablet 400 mg
Oral
14
1
Chem mart Norfloxacin

 
 
 
 
 
GenRx Norfloxacin

 
 
 
 
 
Genepharm Pty Ltd

 
 
 
 
 
Norflohexal

 
 
 
 
 
Noroxin

 
 
 
 
 
Nufloxib

 
 
 
 
 
Roxin

 
 
 
 
 
Terry White Chemists Norfloxacin

Nortriptyline
Tablet 10 mg (as hydrochloride)
Oral
50
2
Allegron

 
Tablet 25 mg (as hydrochloride)
Oral
50
2
Allegron

Nystatin
Tablet 500,000 units
Oral
50
..
Nilstat

 
Capsule 500,000 units
Oral
50
..
Nilstat

 
Oral suspension 100,000 units per mL, 24 mL
Oral
1
1
Mycostatin
Nilstat

 
Cream 100,000 units per g, 15 g
Application
2
3
Mycostatin

Oestradiol
Tablet 2 mg
Oral
56
2
Zumenon

 
Tablet containing oestradiol valerate 1 mg
Oral
56
2
Progynova

 
Tablet containing oestradiol valerate 2 mg
Oral
56
2
Progynova

 
Nasal spray containing oestradiol hemihydrate 150 micrograms per actuation, 60 actuations, 4.2 mL
Nasal
1
5
Aerodiol

 
Transdermal gel 1 mg (as hemihydrate) in 1 g sachet, 28
Transdermal
1
5
Sandrena

 
Transdermal patches 390 micrograms, 8
Transdermal
1
5
Estradot 25

 
Transdermal patches 750 micrograms (as hemihydrate), 8
Transdermal
1
5
Estraderm Mayne Pharma Pty Ltd 25

 
Transdermal patches 2 mg, 4
Transdermal
1
5
Climara 25
Femtran 25

 
Transdermal patches 2 mg, 8
Transdermal
1
5
Estraderm 25

 
Transdermal patches 585 micrograms, 8
Transdermal
1
5
Estradot 37.5

 
Transdermal patches 3.28 mg, 8
Transdermal
1
5
Menorest 37.5

 
Transdermal patches 1.5 mg (as hemihydrate), 8
Transdermal
1
5
Estraderm Mayne Pharma Pty Ltd 50

 
Transdermal patches 3.8 mg, 4
Transdermal
1
5
Climara 50
Femtran 50

 
Transdermal patches 4 mg, 8
Transdermal
1
5
Estraderm 50

 
Transdermal patches 780 micrograms, 8
Transdermal
1
5
Estradot 50

 
Transdermal patches 4.33 mg, 8
Transdermal
1
5
Menorest 50

 
Transdermal patches 5.7 mg, 4
Transdermal
1
5
Climara 75

 
Transdermal patches 1.17 mg, 8
Transdermal
1
5
Estradot 75

 
Transdermal patches 6.57 mg, 8
Transdermal
1
5
Menorest 75

 
Transdermal patches 3 mg (as hemihydrate), 8
Transdermal
1
5
Estraderm Mayne Pharma Pty Ltd 100

 
Transdermal patches 7.6 mg, 4
Transdermal
1
5
Climara 100
Femtran 100

 
Transdermal patches 8 mg, 8
Transdermal
1
5
Estraderm 100

 
Transdermal patches 1.56 mg, 8
Transdermal
1
5
Estradot 100

 
Transdermal patches 8.66 mg, 8
Transdermal
1
5
Menorest 100

 
Vaginal tablets 25 micrograms, 15
Vaginal
1
2
Vagifem

Oestradiol and Oestradiol with Dydrogesterone
Pack containing 14 tablets oestradiol 2 mg and 14 tablets oestradiol 2 mg with dydrogesterone 10 mg
Oral
1
5
Femoston 2/10

Oestradiol and Oestradiol with Norethisterone
Pack containing 12 tablets oestradiol 2 mg, 10 tablets oestradiol 2 mg with norethisterone acetate 1 mg and 6 tablets oestradiol 1 mg
Oral
1
5
Trisequens

 
Pack containing 4 transdermal patches 4.33 mg oestradiol (as hemihydrate) and 4 transdermal patches 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate
Transdermal
1
5
Estalis sequi 50/140

 
Pack containing 4 transdermal patches 4.33 mg oestradiol (as hemihydrate) and 4 transdermal patches 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate
Transdermal
1
5
Estalis sequi 50/250

 
Pack containing 4 transdermal patches oestradiol 4 mg and 4 transdermal patches oestradiol 10 mg with norethisterone acetate 30 mg
Transdermal
1
5
Estracombi

Oestradiol with Norethisterone
Tablets containing 1 mg oestradiol (as hemihydrate) with 500 micrograms norethisterone acetate, 28
Oral
1
5
Kliovance

 
Tablets containing 2 mg oestradiol (as hemihydrate) with 1 mg norethisterone acetate, 28
Oral
1
5
Kliogest

 
Transdermal patches containing 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate, 8
Transdermal
1
5
Estalis continuous 50/140

 
Transdermal patches containing 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate, 8
Transdermal
1
5
Estalis continuous 50/250

Oestriol
Pessaries 500 micrograms, 15
Vaginal
1
2
Ovestin Ovula

 
Vaginal cream 1 mg per g, 15 g
Application
1
1
Ovestin

Oestrogens—Conjugated
Tablet 300 micrograms
Oral
56
2
Premarin

 
Tablet 625 micrograms
Oral
56
2
Premarin

Oestrogens—Conjugated with Medroxyprogesterone
Tablets containing conjugated oestrogens 625 micrograms with medroxyprogesterone acetate 2.5 mg, 28
Oral
1
5
Premia 2.5 Continuous

 
Tablets containing conjugated oestrogens 625 micrograms with medroxyprogesterone acetate 5 mg, 28
Oral
1
5
Premia 5 Continuous

Ofloxacin
Eye drops 3 mg per mL, 5 mL
Application to the eye
2
..
Ocuflox

Olanzapine
Tablet 2.5 mg
Oral
28
5
Zyprexa

 
Tablet 5 mg
Oral
28
5
Zyprexa

 
Tablet 7.5 mg
Oral
28
5
Zyprexa

 
Tablet 10 mg
Oral
28
5
Zyprexa

 
Wafer 5 mg
Oral
28
5
Zyprexa Zydis

 
Wafer 10 mg
Oral
28
5
Zyprexa Zydis

Olmesartan
Tablet containing olmesartan medoxomil 20 mg
Oral
30
5
Olmetec

 
Tablet containing olmesartan medoxomil 40 mg
Oral
30
5
Olmetec

Olmesartan with Hydrochlorothiazide
Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg
Oral
30
5
Olmetec Plus

 
Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg
Oral
30
5
Olmetec Plus

 
Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg
Oral
30
5
Olmetec Plus

Olsalazine
Capsule containing olsalazine sodium 250 mg
Oral
100
5
Dipentum

 
Tablet containing olsalazine sodium 500 mg
Oral
100
5
Dipentum

Omeprazole
Tablet 20 mg
Oral
30
1
Meprazol
Omeprazole Winthrop

 
Tablet 20 mg (as magnesium)
Oral
30
1
Acimax Tablets
Losec Tablets
Omepral

 
Capsule 20 mg
Oral
30
1
Probitor

 
Tablet 10 mg (as magnesium)
Oral
30
5
Losec Tablets

Omeprazole and Clarithromycin and Amoxycillin
Pack containing 14 capsules omeprazole 20 mg, 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate)
Oral
1
..
Klacid Hp 7

Ondansetron
Tablet 4 mg (as hydrochloride dihydrate)
Oral
4
..
Ondansetron-RL

 
 
 
 
 
Ondaz

 
 
 
 
 
Onsetron 4

 
 
 
 
 
Zofran

 
Tablet 8 mg (as hydrochloride dihydrate)
Oral
4
..
Ondansetron-RL

 
 
 
 
 
Ondaz

 
 
 
 
 
Onsetron 8

 
 
 
 
 
Zofran

 
Wafer 4 mg
Oral
4
..
Ondansetron-RL Zydis
Ondaz Zydis
Zofran Zydis

 
Wafer 8 mg
Oral
4
..
Ondansetron-RL Zydis
Ondaz Zydis
Zofran Zydis

 
Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL
Oral
1
1
Zofran syrup 50 mL

 
I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL
Injection
1
..
Ondansetron-RL

 
 
 
 
 
Ondaz

 
 
 
 
 
Pfizer Pty Limited

 
 
 
 
 
Zofran

 
I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL
Injection
1
..
Ondansetron-RL

 
 
 
 
 
Ondaz

 
 
 
 
 
Pfizer Pty Limited

 
 
 
 
 
Zofran

Oxaliplatin
Solution concentrate for I.V. infusion 50 mg in 10 mL
Injection
1
2
Eloxatin

 
Powder for I.V. infusion 50 mg
Injection
1
2
Mayne Pharma Pty Ltd

 
 
 
 
 
Oxalatin

 
 
 
 
 
Oxaliplatin Ebewe

 
 
 
 
 
Winthrop Oxaliplatin

 
Solution concentrate for I.V. infusion 100 mg in 20 mL
Injection
1
2
Eloxatin

 
Powder for I.V. infusion 100 mg
Injection
1
2
Mayne Pharma Pty Ltd

 
 
 
 
 
Oxalatin

 
 
 
 
 
Oxaliplatin Ebewe

 
 
 
 
 
Winthrop Oxaliplatin

Oxazepam
Tablet 15 mg
Oral
25
..
Alepam 15
Serepax

 
Tablet 30 mg
Oral
25
..
Alepam 30
Murelax
Serepax

Oxcarbazepine
Tablet 150 mg
Oral
100
5
Trileptal

 
Tablet 300 mg
Oral
100
5
Trileptal

 
Tablet 600 mg
Oral
100
5
Trileptal

 
Oral suspension 60 mg per mL, 250 mL
Oral
2
5
Trileptal

Oxprenolol
Tablet containing oxprenolol hydrochloride 20 mg
Oral
100
5
Corbeton 20

 
Tablet containing oxprenolol hydrochloride 40 mg
Oral
100
5
Corbeton 40

Oxybutynin
Tablet containing oxybutynin hydrochloride 5 mg
Oral
100
5
Ditropan
Oxybutynin Sandoz

Oxycodone
Tablet containing oxycodone hydrochloride 5 mg
Oral
20
..
Endone

 
Capsule containing oxycodone hydrochloride 5 mg
Oral
20
..
OxyNorm

 
Capsule containing oxycodone hydrochloride 10 mg
Oral
20
..
OxyNorm

 
Capsule containing oxycodone hydrochloride 20 mg
Oral
20
..
OxyNorm

 
Oral solution containing oxycodone hydrochloride 5 mg per 5 mL, 250 mL
Oral
1
..
OxyNorm Liquid 5mg/5mL

 
Tablet containing oxycodone hydrochloride 5 mg (controlled release)
Oral
20
..
OxyContin

 
Tablet containing oxycodone hydrochloride 10 mg (controlled release)
Oral
20
..
OxyContin

 
Tablet containing oxycodone hydrochloride 20 mg (controlled release)
Oral
20
..
OxyContin

 
Tablet containing oxycodone hydrochloride 40 mg (controlled release)
Oral
20
..
OxyContin

 
Tablet containing oxycodone hydrochloride 80 mg (controlled release)
Oral
20
..
OxyContin

 
Suppository 30 mg (as pectinate)
Rectal
12
..
Proladone

Paclitaxel
Solution concentrate for I.V. infusion 30 mg in 5 mL vial
Injection
5
..
Anzatax
Paclitaxel Ebewe
Taxol

 
Solution concentrate for I.V. infusion 100 mg in 16.7 mL vial
Injection
2
..
Anzatax
Paclitaxel Ebewe
Taxol

 
Solution concentrate for I.V. infusion 150 mg in 25 mL vial
Injection
2
..
Anzatax
Paclitaxel Ebewe
Taxol

 
Solution concentrate for I.V. infusion 300 mg in 50 mL vial
Injection
1
..
Anzatax
Paclitaxel Ebewe
Taxol

Pamidronic Acid
Concentrated injection containing disodium pamidronate 15 mg in 5 mL
Injection
4
..
Pamisol

 
Injection set containing 4 vials powder for I.V. infusion containing disodium pamidronate 15 mg and 4 ampoules solvent 5 mL
Injection
1
..
Aredia 15 mg

 
Concentrated injection containing disodium pamidronate 30 mg in 10 mL
Injection
2
..
Pamisol

 
Injection set containing 2 vials powder for I.V. infusion containing disodium pamidronate 30 mg and 2 ampoules solvent 10 mL
Injection
1
..
Aredia 30 mg

 
Concentrated injection containing disodium pamidronate 60 mg in 10 mL
Injection
1
..
Pamisol

Pancreatic Extract
Capsule (containing enteric coated minimicrospheres) providing not less than 5,000 BP units of lipase activity
Oral
500
10
Creon 5000

 
Capsule (containing enteric coated minimicrospheres) providing not less than 10,000 BP units of lipase activity
Oral
500
10
Creon

 
Capsule (containing enteric coated minimicrospheres) providing not less than 25,000 BP units of lipase activity
Oral
200
10
Creon Forte

Pancrelipase
Capsule (containing enteric coated microspheres) providing not less than 10,000 BP units of lipase activity
Oral
500
10
Cotazym-S Forte

 
Capsule (containing enteric coated microtablets) providing not less than 25,000 BP units of lipase activity
Oral
200
10
Panzytrat 25000

Pantoprazole
Tablet (enteric coated) 40 mg (as sodium sesquihydrate)
Oral
30
2
Somac

 
Tablet (enteric coated) 20 mg (as sodium sesquihydrate)
Oral
30
5
Somac

Paracetamol
Tablet 500 mg
Oral
100
1
Chem mart Chemadol

 
 
 
 
 
Dymadon P

 
 
 
 
 
Febridol

 
 
 
 
 
Panamax

 
 
 
 
 
Parahexal

 
 
 
 
 
Paralgin

 
 
 
 
 
Parmol

 
 
 
 
 
Terry White Chemists Paracetamol

 
 
 
 
 
Tylenol

 
Tablet 665 mg (modified release)
Oral
192
5
Duatrol SR
Panadol Osteo

 
Oral liquid 120 mg per 5 mL, 100 mL
Oral
1
2
Panamax

 
Oral liquid 240 mg per 5 mL, 200 mL
Oral
1
2
Panamax 240 Elixir

Paraffin
Eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g
Application to the eye
2
5
Duratears
Poly Visc

 
Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g
Application to the eye
1
5
Ircal
Lacri-Lube
Poly Visc

Paroxetine
Tablet 20 mg (as hydrochloride)
Oral
30
5
Aropax

 
 
 
 
 
Chem mart Paroxetine

 
 
 
 
 
Extine 20

 
 
 
 
 
GenRx Paroxetine

 
 
 
 
 
Oxetine

 
 
 
 
 
Paroxetine 20

 
 
 
 
 
Paroxetine-DP

 
 
 
 
 
Paxtine

 
 
 
 
 
Terry White Chemists Paroxetine

Pemetrexed
Powder for I.V. infusion 500 mg (as disodium heptahydrate)
Injection
2
2
Alimta

Penicillamine
Tablet 125 mg
Oral
100
1
D-Penamine

 
Tablet 250 mg
Oral
100
1
D-Penamine

"Pepti-Junior"
Oral powder 450 g
Oral
8
5
Pepti-Junior

Pergolide
Tablet 50 micrograms (as mesylate)
Oral
100
..
Permax

 
Tablet 250 micrograms (as mesylate)
Oral
100
5
Permax

 
Tablet 1 mg (as mesylate)
Oral
100
5
Permax

Perhexiline
Tablet containing perhexiline maleate 100 mg
Oral
100
5
Pexsig

Pericyazine
Tablet 2.5 mg
Oral
100
5
Neulactil

 
Tablet 10 mg
Oral
100
5
Neulactil

Perindopril
Tablet containing perindopril erbumine 2 mg
Oral
30
5
Chem mart Perindopril

 
 
 
 
 
GenRx Perindopril

 
 
 
 
 
Perindo

 
 
 
 
 
Perindopril 2

 
 
 
 
 
Perindopril-DP

 
 
 
 
 
Terry White Chemists Perindopril

 
Tablet containing perindopril arginine 2.5 mg
Oral
30
5
Coversyl 2.5mg

 
Tablet containing perindopril erbumine 4 mg
Oral
30
5
Chem mart Perindopril

 
 
 
 
 
GenRx Perindopril

 
 
 
 
 
Perindo

 
 
 
 
 
Perindopril 4

 
 
 
 
 
Perindopril-DP

 
 
 
 
 
Terry White Chemists Perindopril

 
Tablet containing perindopril arginine 5 mg
Oral
30
5
Coversyl 5mg

 
Tablet containing perindopril erbumine 8 mg
Oral
30
5
Chem mart Perindopril

 
 
 
 
 
GenRx Perindopril

 
 
 
 
 
Perindo

 
 
 
 
 
Perindopril 8

 
 
 
 
 
Perindopril-DP

 
 
 
 
 
Terry White Chemists Perindopril

 
Tablet containing perindopril arginine 10 mg
Oral
30
5
Coversyl 10mg

Perindopril with Indapamide
Tablet containing perindopril arginine 2.5 mg with indapamide hemihydrate 0.625 mg
Oral
30
5
Coversyl Plus LD 2.5mg/0.625mg

 
Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg
Oral
30
5
Chem mart Perindopril/ Indapamide 4/1.25
GenRx Perindopril/ Indapamide 4/1.25
Terry White Chemists Perindopril/ Indapamide 4/1.25

 
Tablet containing perindopril arginine 5 mg with indapamide hemihydrate 1.25 mg
Oral
30
5
Coversyl Plus 5mg/1.25mg

Permethrin
Cream 50 mg per g, 30 g
Application
1
1
Lyclear

Phenelzine
Tablet 15 mg (as sulfate)
Oral
100
1
Nardil

"Phenex-1"
Oral powder 350 g
Oral
8
5
Phenex-1

"Phenex-2"
Oral powder 325 g
Oral
10
5
Phenex-2

 
Oral powder 400 g
Oral
8
5
Phenex-2

Phenobarbitone
Tablet 30 mg
Oral
200
4
Sigma Pharmaceuticals Pty Ltd

 
Injection containing phenobarbitone sodium 200 mg in 1 mL
Injection
5
..
Fawns and McAllan Pty Ltd

Phenoxybenzamine
Capsule containing phenoxybenzamine hydrochloride 10 mg
Oral
100
5
Dibenyline

Phenoxymethylpenicillin
Tablet 250 mg phenoxymethylpenicillin (as potassium)
Oral
50
..
Abbocillin-VK Filmtab

 
Tablet 500 mg phenoxymethylpenicillin (as potassium)
Oral
50
..
Abbocillin-VK Filmtab

 
Capsule 250 mg phenoxymethylpenicillin (as potassium)
Oral
50
..
Cilicaine VK

 
 
 
 
 
Cilopen VK

 
 
 
 
 
LPV

 
 
 
 
 
Penhexal VK

 
Capsule 500 mg phenoxymethylpenicillin (as potassium)
Oral
50
..
Cilicaine VK

 
 
 
 
 
Cilopen VK

 
 
 
 
 
LPV

 
 
 
 
 
Penhexal VK

 
Oral suspension 125 mg (as benzathine) per 5 mL, 100 mL
Oral
2
..
Abbocillin-V
Cilicaine V

 
Oral suspension 250 mg (as benzathine) per 5 mL, 100 mL
Oral
2
..
Abbocillin-V
Cilicaine V

Phenytoin
Tablet 50 mg
Oral
200
2
Dilantin Infatabs

 
Capsule containing phenytoin sodium 30 mg
Oral
200
2
Dilantin Sodium

 
Capsule containing phenytoin sodium 100 mg
Oral
200
2
Dilantin Sodium

 
Oral suspension 30 mg per 5 mL, 500 mL
Oral
1
3
Dilantin

"Phlexy-10"
Capsules 500 mg, 200
Oral
16
5
Phlexy-10

 
Tablets 1 g, 75
Oral
24
5
Phlexy-10

 
Bars 42 g, 20
Oral
10
5
Phlexy-10

"Phlexy-10 Drink Mix"
Sachets containing oral powder 20 g, 30
Oral
7
5
Phlexy-10 Drink Mix

Pilocarpine
Eye drops containing pilocarpine hydrochloride 5 mg per mL, 15 mL
Application to the eye
1
5
P.V. Carpine
Pilopt

 
Eye drops containing pilocarpine hydrochloride 10 mg per mL, 15 mL
Application to the eye
1
5
Isopto Carpine
P.V. Carpine
Pilopt

 
Eye drops containing pilocarpine hydrochloride 20 mg per mL, 15 mL
Application to the eye
1
5
Isopto Carpine
P.V. Carpine
Pilopt

 
Eye drops containing pilocarpine hydrochloride 40 mg per mL, 15 mL
Application to the eye
1
5
Isopto Carpine
P.V. Carpine
Pilopt

 
Eye drops containing pilocarpine hydrochloride 60 mg per mL, 15 mL
Application to the eye
1
5
P.V. Carpine
Pilopt

Pimecrolimus
Cream 10 mg per g, 15 g
Application
1
1
Elidel

Pindolol
Tablet 5 mg
Oral
100
5
Barbloc 5
Visken 5

 
Tablet 15 mg
Oral
50
5
Barbloc 15
Visken 15

Pioglitazone
Tablet 15 mg (as hydrochloride)
Oral
28
5
Actos

 
Tablet 30 mg (as hydrochloride)
Oral
28
5
Actos

 
Tablet 45 mg (as hydrochloride)
Oral
28
5
Actos

Piperazine Oestrone
Tablet 730 micrograms (as sulfate)
Oral
56
2
Genoral 0.625
Ogen .625

 
Tablet 1.46 mg (as sulfate)
Oral
56
2
Genoral 1.25
Ogen 1.25

Piroxicam
Dispersible tablet 10 mg
Oral
50
3
Feldene-D

 
 
 
 
 
GenRx Piroxicam Dispersible

 
 
 
 
 
Mobilis D-10

 
 
 
 
 
Pirohexal-D

 
Dispersible tablet 20 mg
Oral
25
3
Chem mart Piroxicam Dispersible

 
 
 
 
 
Feldene-D

 
 
 
 
 
GenRx Piroxicam Dispersible

 
 
 
 
 
Mobilis D-20

 
 
 
 
 
Pirohexal-D

 
 
 
 
 
Terry White Chemists Piroxicam Dispersible

 
Capsule 10 mg
Oral
50
3
Chem mart Piroxicam

 
 
 
 
 
Feldene

 
 
 
 
 
GenRx Piroxicam

 
 
 
 
 
Mobilis 10

 
 
 
 
 
Terry White Chemists Piroxicam

 
Capsule 20 mg
Oral
25
3
Chem mart Piroxicam

 
 
 
 
 
Feldene

 
 
 
 
 
GenRx Piroxicam

 
 
 
 
 
Mobilis 20

 
 
 
 
 
Terry White Chemists Piroxicam

Pizotifen
Tablet 500 micrograms (as malate)
Oral
100
2
Sandomigran 0.5

"PK AID II"
Oral powder 250 g
Oral
8
5
PK AID II

"PKU Cooler 10"
Oral liquid 87 mL, 30
Oral
4
5
PKU Cooler 10

"PKU Cooler 15"
Oral liquid 130 mL, 30
Oral
4
5
PKU Cooler 15

"PKU Cooler 20"
Oral liquid 174 mL, 30
Oral
4
5
PKU Cooler 20

"PKU-Express"
Sachets containing oral powder 25 g, 30
Oral
4
5
PKU-Express

"PKU-gel"
Sachets containing oral powder 20 g, 30
Oral
4
5
PKU-gel

Pneumococcal Vaccine - Polyvalent
Injection 0.5 mL (23 valent)
Injection
1
..
Pneumovax 23

Polyethylene Glycol 400 with Propylene Glycol
Eye drops 4 mg-3 mg per mL, 15 mL
Application to the eye
1
5
Systane

Polygeline
I.V. infusion 17.5 g per 500 mL with electrolytes, 500 mL
Injection
3
..
Haemaccel

Polyvinyl Alcohol
Eye drops 14 mg per mL, 15 mL
Application to the eye
1
5
Liquifilm Tears
PVA Tears

 
Eye drops 14 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative)
Application to the eye
1
5
Vistil

 
Eye drops 30 mg per mL, 15 mL
Application to the eye
1
5
Liquifilm Forte
PVA Forte

 
Eye drops 30 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative)
Application to the eye
1
5
Vistil Forte

Potassium Chloride
Tablet 600 mg (sustained release)
Oral
200
1
Duro-K
Slow-K
Span-K

Potassium Chloride with Potassium Bicarbonate
Tablet, effervescent, 14 mmol potassium and 8 mmol chloride
Oral
60
1
Chlorvescent
K-Sol

Pravastatin
Tablet containing pravastatin sodium 10 mg
Oral
30
5
Chem mart Pravastatin

 
 
 
 
 
Cholstat 10

 
 
 
 
 
GenRx Pravastatin

 
 
 
 
 
Lipostat 10

 
 
 
 
 
Liprachol

 
 
 
 
 
Pravachol

 
 
 
 
 
Pravastatin 10

 
 
 
 
 
Pravastatin-DP

 
 
 
 
 
Pravastatin-RL

 
 
 
 
 
Pravastatin Winthrop

 
 
 
 
 
Terry White Chemists Pravastatin

 
Tablet containing pravastatin sodium 20 mg
Oral
30
5
Chem mart Pravastatin

 
 
 
 
 
Cholstat 20

 
 
 
 
 
GenRx Pravastatin

 
 
 
 
 
Lipostat 20

 
 
 
 
 
Liprachol

 
 
 
 
 
Pravachol

 
 
 
 
 
Pravastatin 20

 
 
 
 
 
Pravastatin-DP

 
 
 
 
 
Pravastatin-RL

 
 
 
 
 
Pravastatin Winthrop

 
 
 
 
 
Terry White Chemists Pravastatin

 
Tablet containing pravastatin sodium 40 mg
Oral
30
5
Chem mart Pravastatin

 
 
 
 
 
Cholstat 40

 
 
 
 
 
GenRx Pravastatin

 
 
 
 
 
Lipostat 40

 
 
 
 
 
Liprachol

 
 
 
 
 
Pravachol

 
 
 
 
 
Pravastatin 40

 
 
 
 
 
Pravastatin-DP

 
 
 
 
 
Pravastatin-RL

 
 
 
 
 
Pravastatin Winthrop

 
 
 
 
 
Terry White Chemists Pravastatin

 
Tablet containing pravastatin sodium 80 mg
Oral
30
5
Lipostat 80
Pravachol

Prazosin
Tablet 1 mg (as hydrochloride)
Oral
100
5
Chem mart Prazosin

 
 
 
 
 
GenRx Prazosin

 
 
 
 
 
Minipress

 
 
 
 
 
Pressin 1

 
 
 
 
 
Terry White Chemists Prazosin

 
Tablet 2 mg (as hydrochloride)
Oral
100
5
Chem mart Prazosin

 
 
 
 
 
GenRx Prazosin

 
 
 
 
 
Minipress

 
 
 
 
 
Pressin 2

 
 
 
 
 
Terry White Chemists Prazosin

 
Tablet 5 mg (as hydrochloride)
Oral
100
5
Chem mart Prazosin

 
 
 
 
 
GenRx Prazosin

 
 
 
 
 
Minipress

 
 
 
 
 
Pressin 5

 
 
 
 
 
Terry White Chemists Prazosin

Prednisolone
Tablet 1 mg
Oral
100
4
Panafcortelone
Predsolone

 
Tablet 5 mg
Oral
60
4
Panafcortelone
Solone

 
Tablet 25 mg
Oral
30
4
Panafcortelone
Solone

 
Oral solution 5 mg (as sodium phosphate) per mL, 30 mL
Oral
1
5
PredMix
Redipred

 
Enema, retention, 20 mg (as sodium phosphate) in 100 mL
Rectal
28
3
Predsol

 
Suppositories 5 mg (as sodium phosphate), 10
Rectal
3
3
Predsol

Prednisolone with Phenylephrine
Eye drops containing prednisolone acetate 10 mg with phenylephrine hydrochloride 1.2 mg per mL, 10 mL
Application to the eye
1
2
Prednefrin Forte

Prednisone
Tablet 1 mg
Oral
100
4
Panafcort
Predsone

 
Tablet 5 mg
Oral
60
4
Panafcort
Sone

 
Tablet 25 mg
Oral
30
4
Panafcort
Sone

Primidone
Tablet 250 mg
Oral
200
2
Mysoline

Probenecid
Tablet 500 mg
Oral
100
5
Pro-Cid

Procaine Penicillin
Injection 1.5 g in disposable syringe
Injection
5
..
Cilicaine

Prochlorperazine
Tablet containing prochlorperazine maleate 5 mg
Oral
25
..
Stemetil
Stemzine

 
Injection containing prochlorperazine mesylate 12.5 mg in 1 mL
Injection
10
..
Stemetil

 
Suppositories 3 mg, equivalent to 5 mg prochlorperazine maleate, 5
Rectal
1
2
Stemetil

 
Suppositories 15 mg, equivalent to 25 mg prochlorperazine maleate, 5
Rectal
1
2
Stemetil

Promethazine
Injection containing promethazine hydrochloride 50 mg in 2 mL
Injection
10
..
Mayne Pharma Pty Ltd

Propantheline
Tablet containing propantheline bromide 15 mg
Oral
200
5
Pro-Banthine

"Pro-Phree"
Oral powder 400 g
Oral
8
5
Pro-Phree

Propranolol
Tablet containing propranolol hydrochloride 10 mg
Oral
100
5
Deralin 10
Inderal

 
Tablet containing propranolol hydrochloride 40 mg
Oral
100
5
Deralin 40
Inderal

 
Tablet containing propranolol hydrochloride 160 mg
Oral
50
5
Deralin 160

Propylthiouracil
Tablet 50 mg
Oral
200
2
Pharmalab Pty Ltd

Pyrantel
Tablet 125 mg (as embonate)
Oral
6
..
Anthel 125

 
Tablet 250 mg (as embonate)
Oral
6
..
Anthel 250

Pyridostigmine
Tablet containing pyridostigmine bromide 10 mg
Oral
100
5
Mestinon

 
Tablet containing pyridostigmine bromide 60 mg
Oral
150
5
Mestinon

 
Tablet containing pyridostigmine bromide 180 mg (modified release)
Oral
100
5
Mestinon Timespan

Pyrimethamine
Tablet 25 mg
Oral
50
..
Daraprim

Quetiapine
Tablet 25 mg (as fumarate)
Oral
60
5
Seroquel

 
Tablet 100 mg (as fumarate)
Oral
90
5
Seroquel

 
Tablet 200 mg (as fumarate)
Oral
60
5
Seroquel

 
Tablet 300 mg (as fumarate)
Oral
60
5
Seroquel

Quinagolide
Pack containing 3 tablets quinagolide 25 micrograms (as hydrochloride) and 3 tablets quinagolide 50 micrograms (as hydrochloride)
Oral
1
..
Norprolac

 
Tablet 75 micrograms (as hydrochloride)
Oral
30
5
Norprolac

Quinapril
Tablet 5 mg (as hydrochloride)
Oral
30
5
Accupril
Acquin 5
Filpril

 
Tablet 10 mg (as hydrochloride)
Oral
30
5
Accupril
Acquin 10
Filpril

 
Tablet 20 mg (as hydrochloride)
Oral
30
5
Accupril
Acquin 20
Filpril

Quinapril with Hydrochlorothiazide
Tablet 10 mg quinapril (as hydrochloride) with 12.5 mg hydrochlorothiazide
Oral
30
5
Accuretic 10/12.5mg

 
Tablet 20 mg quinapril (as hydrochloride) with 12.5 mg hydrochlorothiazide
Oral
30
5
Accuretic 20/12.5mg

Quinine
Tablet containing quinine bisulfate 300 mg
Oral
50
2
Quinbisul

 
Tablet containing quinine sulfate 300 mg
Oral
50
2
Quinate
Quinsul

Rabeprazole
Tablet containing rabeprazole sodium 20 mg (enteric coated)
Oral
30
2
Pariet

 
Tablet containing rabeprazole sodium 10 mg (enteric coated)
Oral
28
5
Pariet

Raloxifene
Tablet containing raloxifene hydrochloride 60 mg
Oral
28
5
Evista

Raltitrexed
Powder for I.V. infusion 2 mg in single use vial
Injection
3
2
Tomudex

Ramipril
Tablet 1.25 mg
Oral
30
5
Prilace 1.25

 
 
 
 
 
Ramace 1.25 mg

 
 
 
 
 
Ramipril Sandoz

 
 
 
 
 
Ramipril Winthrop

 
 
 
 
 
Tritace 1.25 mg

 
Tablet 2.5 mg
Oral
30
5
Prilace 2.5

 
 
 
 
 
Ramace 2.5 mg

 
 
 
 
 
Ramipril Sandoz

 
 
 
 
 
Ramipril Winthrop

 
 
 
 
 
Tritace 2.5 mg

 
Tablet 5 mg
Oral
30
5
Prilace 5

 
 
 
 
 
Ramace 5 mg

 
 
 
 
 
Ramipril Sandoz

 
 
 
 
 
Ramipril Winthrop

 
 
 
 
 
Tritace 5 mg

 
Capsule 10 mg
Oral
30
5
Prilace 10

 
 
 
 
 
Ramace 10 mg

 
 
 
 
 
Ramipril Sandoz

 
 
 
 
 
Ramipril Winthrop

 
 
 
 
 
Tritace 10 mg

 
Pack containing 7 tablets 2.5 mg, 21 tablets 5 mg and 10 capsules 10 mg
Oral
1
..
Tritace Titration Pack

Ramipril with Felodipine
Tablet 2.5 mg-2.5 mg (modified release)
Oral
30
5
Triasyn 2.5/2.5

 
Tablet 5 mg-5 mg (modified release)
Oral
30
5
Triasyn 5.0/5.0

Ranibizumab
Solution for intravitreal injection 3 mg in 0.3 mL
Injection
1
..
Lucentis

Ranitidine
Tablet 150 mg (as hydrochloride)
Oral
60
5
Ausran

 
 
 
 
 
Chem mart Ranitidine

 
 
 
 
 
GenRx Ranitidine

 
 
 
 
 
Rani 2

 
 
 
 
 
Ranihexal

 
 
 
 
 
Ranoxyl

 
 
 
 
 
Terry White Chemists Ranitidine

 
 
 
 
 
Ulcaid

 
 
 
 
 
Zantac

 
Tablet, effervescent, 150 mg (as hydrochloride)
Oral
60
5
Zantac

 
Tablet 300 mg (as hydrochloride)
Oral
30
5
Ausran

 
 
 
 
 
Chem mart Ranitidine

 
 
 
 
 
GenRx Ranitidine

 
 
 
 
 
Rani 2

 
 
 
 
 
Ranihexal

 
 
 
 
 
Ranoxyl

 
 
 
 
 
Terry White Chemists Ranitidine

 
 
 
 
 
Ulcaid

 
 
 
 
 
Zantac

 
Syrup 150 mg (as hydrochloride) per 10 mL, 300 mL
Oral
2
5
Zantac Syrup

"RCF"
Oral liquid 384 mL
Oral
120
5
RCF

Reboxetine
Tablet 4 mg (as mesilate)
Oral
60
5
Edronax

Reteplase
Pack containing 2 vials powder for injection 10 units, 2 single use pre-filled syringes with solvent, 2 reconstitution spikes and 2 needles
Injection
1
..
Rapilysin 10 U

Rifampicin
Capsule 150 mg
Oral
10
..
Rimycin 150

 
Capsule 300 mg
Oral
10
..
Rimycin 300

 
Syrup 100 mg per 5 mL, 60 mL
Oral
1
..
Rifadin

Riluzole
Tablet 50 mg
Oral
56
5
Rilutek

Risedronic Acid
Tablet containing risedronate sodium 5 mg
Oral
28
5
Actonel

 
Tablet containing risedronate sodium 35 mg
Oral
4
5
Actonel Once-a-Week

 
Tablet containing risedronate sodium 30 mg
Oral
28
1
Actonel

Risedronic Acid and Calcium
Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate)
Oral
1
5
Actonel Combi

Risperidone
Tablet 0.5 mg
Oral
60
2
Risperdal

 
Tablet 0.5 mg (orally disintegrating)
Oral
56
2
Risperdal Quicklet

 
Tablet 1 mg
Oral
60
2
Risperdal

 
Tablet 1 mg (orally disintegrating)
Oral
56
2
Risperdal Quicklet

 
Tablet 2 mg
Oral
60
2
Risperdal

 
Tablet 2 mg (orally disintegrating)
Oral
56
2
Risperdal Quicklet

 
Tablet 3 mg
Oral
60
5
Risperdal

 
Tablet 3 mg (orally disintegrating)
Oral
56
5
Risperdal Quicklet

 
Tablet 4 mg
Oral
60
5
Risperdal

 
Tablet 4 mg (orally disintegrating)
Oral
56
5
Risperdal Quicklet

 
Oral solution 1 mg per mL, 30 mL
Oral
1
2
Risperdal

 
Oral solution 1 mg per mL, 100 mL
Oral
1
5
Risperdal

 
I.M. injection (modified release), set containing 1 vial powder for injection 25 mg and 1 pre-filled syringe diluent 2 mL
Injection
2
5
Risperdal Consta

 
I.M. injection (modified release), set containing 1 vial powder for injection 37.5 mg and 1 pre-filled syringe diluent 2 mL
Injection
2
5
Risperdal Consta

 
I.M. injection (modified release), set containing 1 vial powder for injection 50 mg and 1 pre-filled syringe diluent 2 mL
Injection
2
5
Risperdal Consta

Rituximab
Solution for I.V. infusion 100 mg in 10 mL
Injection
2
3
Mabthera

 
Solution for I.V. infusion 500 mg in 50 mL
Injection
1
3
Mabthera

Rivastigmine
Capsule 1.5 mg (as hydrogen tartrate)
Oral
56
5
Exelon

 
Capsule 3 mg (as hydrogen tartrate)
Oral
56
5
Exelon

 
Capsule 4.5 mg (as hydrogen tartrate)
Oral
56
5
Exelon

 
Capsule 6 mg (as hydrogen tartrate)
Oral
56
5
Exelon

 
Oral solution 2 mg (as hydrogen tartrate) per mL, 120 mL
Oral
1
5
Exelon

Rosiglitazone
Tablet 4 mg (as maleate)
Oral
28
5
Avandia

 
Tablet 8 mg (as maleate)
Oral
28
5
Avandia

Rosiglitazone with Metformin
Tablet 2 mg rosiglitazone (as maleate) with 500 mg metformin hydrochloride
Oral
56
5
Avandamet

 
Tablet 2 mg rosiglitazone (as maleate) with 1 g metformin hydrochloride
Oral
56
5
Avandamet

 
Tablet 4 mg rosiglitazone (as maleate) with 500 mg metformin hydrochloride
Oral
56
5
Avandamet

 
Tablet 4 mg rosiglitazone (as maleate) with 1 g metformin hydrochloride
Oral
56
5
Avandamet

Rosuvastatin
Tablet 5 mg (as calcium)
Oral
30
5
Crestor

 
Tablet 10 mg (as calcium)
Oral
30
5
Crestor

 
Tablet 20 mg (as calcium)
Oral
30
5
Crestor

 
Tablet 40 mg (as calcium)
Oral
30
5
Crestor

Roxithromycin
Tablet for oral suspension 50 mg
Oral
10
1
Rulide D

 
Tablet 150 mg
Oral
10
1
Biaxsig

 
 
 
 
 
Roxar 150

 
 
 
 
 
Roxide

 
 
 
 
 
Roximycin

 
 
 
 
 
Roxithromycin-RL

 
 
 
 
 
Rulide

 
Tablet 300 mg
Oral
5
1
Biaxsig

 
 
 
 
 
Roxar 300

 
 
 
 
 
Roxide

 
 
 
 
 
Roximycin

 
 
 
 
 
Roxithromycin-RL

 
 
 
 
 
Rulide

"S-26 LF"
Infant formula powder 900 g
Oral
5
..
S-26 LF

Salbutamol
Oral solution 2 mg (as sulfate) per 5 mL, 150 mL
Oral
2
5
Ventolin

 
Capsule containing powder for oral inhalation 200 micrograms (as sulfate) (for use in Ventolin Rotahaler)
Inhalation by mouth
200
5
Ventolin Rotacaps

 
Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation)
Inhalation by mouth
2
5
Airomir
Asmol CFC-free

 
 
 
 
 
Epaq

 
 
 
 
 
Ventolin CFC-free

 
Pressurised inhalation in breath actuated device 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation)
Inhalation by mouth
2
5
Airomir Autohaler

 
Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30
Inhalation
2
5
Asmol 2.5 uni-dose
Butamol 2.5

 
 
 
 
 
Chem mart Salbutamol

 
 
 
 
 
GenRx Salbutamol

 
 
 
 
 
Pfizer Pty Limited

 
 
 
 
 
Terry White Chemists Salbutamol

 
 
 
 
 
Ventolin Nebules

 
Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30
Inhalation
2
5
Asmol 5 uni-dose
Butamol 5

 
 
 
 
 
Chem mart Salbutamol

 
 
 
 
 
GenRx Salbutamol

 
 
 
 
 
Terry White Chemists Salbutamol

 
 
 
 
 
Ventolin Nebules

 
Nebuliser solution 5 mg (as sulfate) per mL, 30 mL
Inhalation
2
2
Pfizer Pty Limited

Salcatonin
Injection 50 I.U. in 1 mL ampoule
Injection
30
5
Miacalcic 50

 
Injection 100 I.U. in 1 mL ampoule
Injection
15
5
Miacalcic 100

Salmeterol
Pressurised inhalation 25 micrograms (as xinafoate) per dose, 120 doses
Inhalation by mouth
1
5
Serevent

 
Powder for oral inhalation in breath actuated device 50 micrograms (as xinafoate) per dose, 60 doses
Inhalation by mouth
1
5
Serevent Accuhaler

Selegiline
Tablet containing selegiline hydrochloride 5 mg
Oral
100
5
Eldepryl
Selgene

Sertraline
Tablet 50 mg (as hydrochloride)
Oral
30
5
Chem mart Sertraline

 
 
 
 
 
Concorz

 
 
 
 
 
Eleva 50

 
 
 
 
 
GenRx Sertraline

 
 
 
 
 
Sertraline 50

 
 
 
 
 
Sertraline-DP

 
 
 
 
 
Sertraline Winthrop

 
 
 
 
 
Setrona

 
 
 
 
 
Terry White Chemists Sertraline

 
 
 
 
 
Xydep 50

 
 
 
 
 
Zoloft

 
Tablet 100 mg (as hydrochloride)
Oral
30
5
Chem mart Sertraline

 
 
 
 
 
Concorz

 
 
 
 
 
Eleva 100

 
 
 
 
 
GenRx Sertraline

 
 
 
 
 
Sertraline 100

 
 
 
 
 
Sertraline-DP

 
 
 
 
 
Sertraline Winthrop

 
 
 
 
 
Setrona

 
 
 
 
 
Terry White Chemists Sertraline

 
 
 
 
 
Xydep 100

 
 
 
 
 
Zoloft

Silver Sulfadiazine with Chlorhexidine
Cream containing silver sulfadiazine 10 mg with chlorhexidine gluconate 2 mg per g, 50 g
Application
1
..
Silvazine

 
Cream containing silver sulfadiazine 10 mg with chlorhexidine gluconate 2 mg per g, 100 g
Application
1
..
Silvazine

Simvastatin
Tablet 5 mg
Oral
30
5
Lipex 5

 
 
 
 
 
Simvabell

 
 
 
 
 
Simvahexal

 
 
 
 
 
Simvastatin-RL

 
 
 
 
 
Simvastatin Winthrop

 
 
 
 
 
Simvasyn

 
 
 
 
 
Zimstat

 
 
 
 
 
Zocor

 
Tablet 10 mg
Oral
30
5
Chem mart Simvastatin

 
 
 
 
 
GenRx Simvastatin

 
 
 
 
 
Genepharm Australasia Limited

 
 
 
 
 
Lipex 10

 
 
 
 
 
Ransim

 
 
 
 
 
Simvabell

 
 
 
 
 
Simvahexal

 
 
 
 
 
Simvar 10

 
 
 
 
 
Simvastatin-DP

 
 
 
 
 
Simvastatin-RL

 
 
 
 
 
Simvastatin Winthrop

 
 
 
 
 
Simvasyn

 
 
 
 
 
Terry White Chemists Simvastatin

 
 
 
 
 
Zimstat

 
 
 
 
 
Zocor

 
Tablet 20 mg
Oral
30
5
Chem mart Simvastatin

 
 
 
 
 
GenRx Simvastatin

 
 
 
 
 
Genepharm Australasia Limited

 
 
 
 
 
Lipex 20

 
 
 
 
 
Ransim

 
 
 
 
 
Simvabell

 
 
 
 
 
Simvahexal

 
 
 
 
 
Simvar 20

 
 
 
 
 
Simvastatin-DP

 
 
 
 
 
Simvastatin-RL

 
 
 
 
 
Simvastatin Winthrop

 
 
 
 
 
Simvasyn

 
 
 
 
 
Terry White Chemists Simvastatin

 
 
 
 
 
Zimstat

 
 
 
 
 
Zocor

 
Tablet 40 mg
Oral
30
5
Chem mart Simvastatin

 
 
 
 
 
GenRx Simvastatin

 
 
 
 
 
Genepharm Australasia Limited

 
 
 
 
 
Lipex 40

 
 
 
 
 
Ransim

 
 
 
 
 
Simvabell

 
 
 
 
 
Simvahexal

 
 
 
 
 
Simvar 40

 
 
 
 
 
Simvastatin-DP

 
 
 
 
 
Simvastatin-RL

 
 
 
 
 
Simvastatin Winthrop

 
 
 
 
 
Simvasyn

 
 
 
 
 
Terry White Chemists Simvastatin

 
 
 
 
 
Zimstat

 
 
 
 
 
Zocor

 
Tablet 80 mg
Oral
30
5
Chem mart Simvastatin

 
 
 
 
 
GenRx Simvastatin

 
 
 
 
 
Genepharm Australasia Limited

 
 
 
 
 
Lipex 80

 
 
 
 
 
Ransim

 
 
 
 
 
Simvabell

 
 
 
 
 
Simvahexal

 
 
 
 
 
Simvar 80

 
 
 
 
 
Simvastatin-DP

 
 
 
 
 
Simvastatin-RL

 
 
 
 
 
Simvastatin Winthrop

 
 
 
 
 
Simvasyn

 
 
 
 
 
Terry White Chemists Simvastatin

 
 
 
 
 
Zimstat

 
 
 
 
 
Zocor

Sirolimus
Tablet 1 mg
Oral
100
3
Rapamune

 
Tablet 2 mg
Oral
100
3
Rapamune

 
Oral solution 1 mg per mL, 60 mL
Oral
1
3
Rapamune

Sodium Acid Phosphate
Tablet, compound effervescent, equivalent to 500 mg phosphorus
Oral
100
5
Phosphate Sandoz

Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate
Oral liquid 1 g-320 mg-534 mg in 20 mL, 500 mL
Oral
2
5
Gaviscon P

Sodium Chloride
Injection 9 mg per mL, 10 mL
Injection
5
1
Pfizer Pty Limited

 
I.V. infusion 154 mmol per L, 1 L
Injection
5
1
Baxter Healthcare Pty Limited

 
I.V. infusion 513 mmol per L, 1 L
Injection
2
1
Baxter Healthcare Pty Limited

Sodium Chloride Compound
I.V. infusion containing approximately 148 mmol sodium (as chloride), 4 mmol potassium (as chloride), 2 mmol calcium (as chloride) and 156 mmol chloride per L, 1 L
Injection
4
1
Baxter Healthcare Pty Limited

Sodium Chloride with Glucose
I.V. infusion 31 mmol-222 mmol (anhydrous) per L, 1 L
Injection
5
1
Baxter Healthcare Pty Limited

 
I.V. infusion 19 mmol-104 mmol (anhydrous) per 500 mL, 500 mL
Injection
5
1
Baxter Healthcare Pty Limited

 
I.V. infusion 39 mmol-69 mmol (anhydrous) per 500 mL, 500 mL
Injection
5
1
Baxter Healthcare Pty Limited

Sodium Lactate Compound
I.V. infusion containing approximately 131 mmol sodium (as lactate and chloride), 5 mmol potassium (as chloride), 2 mmol calcium (as chloride), 29 mmol bicarbonate (as lactate) and 111 mmol chloride per L, 1 L
Injection
5
1
Baxter Healthcare Pty Limited

Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate
Enemas 3.125 g-450 mg-45 mg in 5 mL, 12
Rectal
2
2
Microlax

Sotalol
Tablet containing sotalol hydrochloride 80 mg
Oral
60
5
GenRx Sotalol

 
 
 
 
 
Solavert

 
 
 
 
 
Sotacor

 
 
 
 
 
Sotahexal

 
Tablet containing sotalol hydrochloride 160 mg
Oral
60
5
Cardol

 
 
 
 
 
Chem mart Sotalol

 
 
 
 
 
GenRx Sotalol

 
 
 
 
 
Solavert

 
 
 
 
 
Sotab

 
 
 
 
 
Sotacor

 
 
 
 
 
Sotahexal

 
 
 
 
 
Terry White Chemists Sotalol

Spironolactone
Tablet 25 mg
Oral
100
5
Aldactone
Spiractin 25

 
Tablet 100 mg
Oral
100
5
Aldactone
Spiractin 100

Sterculia with Frangula Bark
Granules 620 mg-80 mg per g, 500 g
Oral
1
1
Normacol Plus

Strontium
Sachet containing granules for oral suspension containing strontium ranelate 2 g
Oral
28
5
Protos 2 g

Sucralfate
Tablet equivalent to 1 g anhydrous sucralfate
Oral
120
2
Carafate
Ulcyte

Sulfacetamide
Eye drops containing sulfacetamide sodium 100 mg per mL, 15 mL
Application to the eye
1
2
Bleph 10

Sulfasalazine
Tablet 500 mg
Oral
200
5
Salazopyrin

 
Tablet 500 mg (enteric coated)
Oral
200
5
Pyralin EN
Salazopyrin-EN

Sulindac
Tablet 100 mg
Oral
100
3
Aclin

 
Tablet 200 mg
Oral
50
3
Aclin 200

Sulthiame
Tablet 50 mg
Oral
200
2
Ospolot

 
Tablet 200 mg
Oral
200
2
Ospolot

Sumatriptan
Tablet 50 mg (as succinate)
Oral
4
5
Imigran
Sumatab
Suvalan 50

 
Tablet (fast disintegrating) 50 mg (as succinate)
Oral
4
5
Imigran FDT

 
Nasal spray 20 mg in 0.1 mL single dose unit
Nasal
2
5
Imigran

Tacrolimus
Capsule 500 micrograms
Oral
100
3
Prograf

 
Capsule 1 mg
Oral
100
3
Prograf

 
Capsule 5 mg
Oral
50
3
Prograf

Tamoxifen
Tablet 10 mg (as citrate)
Oral
60
5
Genox 10
Nolvadex
Tamoxen 10 mg

 
Tablet 20 mg (as citrate)
Oral
60
5
Chem mart Tamoxifen

 
 
 
 
 
Genox 20

 
 
 
 
 
GenRx Tamoxifen

 
 
 
 
 
Nolvadex-D

 
 
 
 
 
Tamosin

 
 
 
 
 
Tamoxen 20 mg

 
 
 
 
 
Tamoxifen Hexal

 
 
 
 
 
Terry White Chemists Tamoxifen

Telmisartan
Tablet 40 mg
Oral
28
5
Micardis

 
Tablet 80 mg
Oral
28
5
Micardis

Telmisartan with Hydrochlorothiazide
Tablet 40 mg-12.5 mg
Oral
28
5
Micardis Plus 40/12.5 mg

 
Tablet 80 mg-12.5 mg
Oral
28
5
Micardis Plus 80/12.5 mg

Temazepam
Tablet 10 mg
Oral
25
..
Normison
Temaze
Temtabs

Temozolomide
Capsule 5 mg
Oral
15
2
Temodal

 
Capsule 20 mg
Oral
15
2
Temodal

 
Capsule 100 mg
Oral
15
2
Temodal

 
Capsule 250 mg
Oral
5
5
Temodal

Tenecteplase
Powder for injection 40 mg with solvent
Injection
1
..
Metalyse

 
Powder for injection 50 mg with solvent
Injection
1
..
Metalyse

Terbinafine
Tablet 250 mg (as hydrochloride)
Oral
42
1
GenRx Terbinafine

 
 
 
 
 
Lamisil

 
 
 
 
 
Tamsil

 
 
 
 
 
Terbihexal

 
 
 
 
 
Terbinafine 250

 
 
 
 
 
Terbinafine-DP

 
 
 
 
 
Zabel

Terbutaline
Injection containing terbutaline sulfate 500 micrograms in 1mL
Injection
5
..
Bricanyl

 
Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 200 doses
Inhalation by mouth
1
5
Bricanyl Turbuhaler

 
Nebuliser solution containing terbutaline sulfate 5 mg in 2 mL single dose units, 30
Inhalation
2
5
Bricanyl Respules

Testosterone
Capsule containing testosterone undecanoate 40 mg
Oral
60
5
Andriol Testocaps

 
Subcutaneous implant 100 mg
Implantation
6
..
Organon (Australia) Pty Limited

 
Injection containing testosterone enanthate 250 mg in 1 mL
Injection
3
3
Primoteston Depot

 
Injection containing testosterone esters (20 mg testosterone propionate, 40 mg testosterone phenylpropionate, 40 mg testosterone isocaproate) in 1 mL
Injection
3
3
Sustanon 100

 
I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL
Injection
1
1
Reandron 1000

 
Subcutaneous implant 200 mg
Implantation
3
..
Organon (Australia) Pty Limited

 
Injection containing testosterone esters (30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaprate, 100 mg testosterone decanoate) in 1 mL
Injection
3
3
Sustanon 250

 
Transdermal gel 50 mg in 5 g sachet, 30
Transdermal
1
5
Testogel

 
Transdermal patches 12.2 mg, 60
Transdermal
1
5
Androderm

 
Transdermal patches 24.3 mg, 30
Transdermal
1
5
Androderm

Tetrabenazine
Tablet 25 mg
Oral
112
5
Orphan Australia Pty Ltd

Tetracosactrin
Compound depot injection 1 mg in 1 mL
Injection
5
5
Synacthen Depot 1 mg/1 mL

Theophylline
Tablet 200 mg (sustained release)
Oral
100
5
Nuelin-SR 200

 
Tablet 250 mg (sustained release)
Oral
100
5
Nuelin-SR 250

 
Tablet 300 mg (sustained release)
Oral
100
5
Nuelin-SR 300

 
Oral solution 133.3 mg per 25 mL, 500 mL
Oral
1
5
Nuelin

Thiamine
Tablet containing thiamine hydrochloride 100 mg
Oral
100
2
Betamin

Thioguanine
Tablet 40 mg
Oral
25
1
Lanvis

Thioridazine
Tablet containing thioridazine hydrochloride 10 mg
Oral
100
5
Aldazine 10

 
Tablet containing thioridazine hydrochloride 25 mg
Oral
100
5
Aldazine 25

 
Tablet containing thioridazine hydrochloride 50 mg
Oral
100
5
Aldazine 50

 
Tablet containing thioridazine hydrochloride 100 mg
Oral
100
5
Aldazine 100

Thiotepa
Powder for injection 15 mg
Injection/intravesical
2
1
Sigma Pharmaceuticals Pty Ltd

Thyrotropin Alfa
Powder for injection 0.9 mg, 2
Injection
1
..
Thyrogen

Thyroxine
Tablet containing 50 micrograms anhydrous thyroxine sodium
Oral
200
1
Eutroxsig
Oroxine

 
Tablet containing 100 micrograms anhydrous thyroxine sodium
Oral
200
1
Eutroxsig
Oroxine

 
Tablet containing 200 micrograms anhydrous thyroxine sodium
Oral
200
1
Eutroxsig
Oroxine

Tiagabine
Tablet 5 mg (as hydrochloride)
Oral
100
5
Gabitril

 
Tablet 10 mg (as hydrochloride)
Oral
100
5
Gabitril

 
Tablet 15 mg (as hydrochloride)
Oral
100
5
Gabitril

Tiaprofenic Acid
Tablet 300 mg
Oral
60
3
Surgam

Ticarcillin with Clavulanic Acid
Powder for injection containing ticarcillin 3 g (as sodium) with 100 mg clavulanic acid (as potassium clavulanate) (with any determined brand of sodium chloride injection as the required solvent)
Injection
10
..
Timentin

Ticlopidine
Tablet containing ticlopidine hydrochloride 250 mg
Oral
60
5
Ticlid
Ticlopidine Hexal
Tilodene

Tiludronic Acid
Tablet 200 mg (as tiludronate disodium)
Oral
56
2
Skelid

Timolol
Eye gel 1 mg (as maleate) per g, 5 g
Application to the eye
1
5
Nyogel

 
Eye drops 2.5 mg (as maleate) per mL, 5 mL
Application to the eye
1
5
Tenopt
Timoptol

 
Eye drops 5 mg (as maleate) per mL, 5 mL
Application to the eye
1
5
Tenopt
Timoptol

 
Eye drops (gellan gum solution) 2.5 mg (as maleate) per mL, 2.5 mL
Application to the eye
1
5
Timoptol XE

 
Eye drops (gellan gum solution) 5 mg (as maleate) per mL, 2.5 mL
Application to the eye
1
5
Timoptol XE

Tinidazole
Tablet 500 mg
Oral
4
..
Fasigyn
Simplotan

Tiotropium
Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in HandiHaler)
Inhalation by mouth
30
5
Spiriva

Tirofiban
Solution concentrate for I.V. infusion 12.5 mg (as hydrochloride) in 50 mL
Injection
1
2
Aggrastat

Tobramycin
Injection 80 mg (as sulfate) in 2 mL
Injection
10
1
Mayne Pharma Pty Ltd

 
Injection 80 mg (as sulfate) in 2 mL (without preservative)
Injection
10
1
Pfizer Pty Limited

 
Eye drops 3 mg per mL, 5 mL
Application to the eye
1
2
Tobrex

 
Eye ointment 3 mg per g, 3.5 g
Application to the eye
1
..
Tobrex

Topiramate
Tablet 25 mg
Oral
60
5
Topamax

 
Tablet 50 mg
Oral
60
5
Topamax

 
Tablet 100 mg
Oral
60
5
Topamax

 
Tablet 200 mg
Oral
60
5
Topamax

 
Capsule 15 mg
Oral
60
5
Topamax Sprinkle

 
Capsule 25 mg
Oral
60
5
Topamax Sprinkle

 
Capsule 50 mg
Oral
60
5
Topamax Sprinkle

Topotecan
Powder for I.V. infusion 4 mg (as hydrochloride)
Injection
5
1
Hycamtin

Toremifene
Tablet 60 mg (as citrate)
Oral
30
5
Fareston

Tramadol
Capsule containing tramadol hydrochloride 50 mg
Oral
20
..
Chem mart Tramadol

 
 
 
 
 
GenRx Tramadol

 
 
 
 
 
Terry White Chemists Tramadol

 
 
 
 
 
Tramal

 
 
 
 
 
Tramedo

 
 
 
 
 
Zydol

 
Tablet containing tramadol hydrochloride 50 mg (sustained release)
Oral
20
..
Tramal SR 50

 
Tablet containing tramadol hydrochloride 100 mg (sustained release)
Oral
20
..
Tramahexal SR
Tramal SR 100
Zydol SR 100

 
Tablet containing tramadol hydrochloride 150 mg (sustained release)
Oral
20
..
Tramahexal SR
Tramal SR 150
Zydol SR 150

 
Tablet containing tramadol hydrochloride 200 mg (sustained release)
Oral
20
..
Tramahexal SR
Tramal SR 200
Zydol SR 200

 
Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL
Oral
1
..
Tramal

 
Injection containing tramadol hydrochloride 100 mg in 2 mL
Injection
5
..
Tramahexal
Tramal 100

Trandolapril
Capsule 500 micrograms
Oral
28
5
Gopten
Odrik
Tranalpha

 
Capsule 1 mg
Oral
28
5
Gopten
Odrik
Tranalpha

 
Capsule 2 mg
Oral
28
5
Gopten
Odrik
Tranalpha

 
Capsule 4 mg
Oral
28
5
Gopten
Tranalpha

Trandolapril with Verapamil
Tablet containing trandolapril 4 mg with verapamil hydrochloride 240 mg (sustained release)
Oral
28
5
Tarka 4/240

Tranexamic Acid
Tablet 500 mg
Oral
100
2
Cyklokapron

Tranylcypromine
Tablet 10 mg (as sulfate)
Oral
50
2
Parnate

Travoprost
Eye drops 40 micrograms per mL, 2.5 mL
Application to the eye
1
5
Travatan

Travoprost with Timolol
Eye drops 40 micrograms travoprost with timolol 5 mg (as maleate) per mL, 2.5 mL
Application to the eye
1
5
Duotrav

Triamcinolone
Injection containing triamcinolone acetonide 10 mg in 1 mL
Injection
5
..
Kenacort-A10

 
Cream containing triamcinolone acetonide 200 micrograms per g, 100 g
Application
2
..
Aristocort 0.02%
Tricortone

 
Ointment containing triamcinolone acetonide 200 micrograms per g, 100 g
Application
2
..
Aristocort 0.02%
Tricortone

Triamcinolone with Neomycin, Gramicidin and Nystatin
Ear drops containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 7.5 mL
Application to the ear
1
2
Kenacomb Otic
Otocomb Otic

 
Ear ointment containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 5 g
Application to the ear
1
2
Kenacomb Otic
Otocomb Otic

Trifluoperazine
Tablet 1 mg (as hydrochloride)
Oral
100
5
Stelazine

 
Tablet 2 mg (as hydrochloride)
Oral
100
5
Stelazine

 
Tablet 5 mg (as hydrochloride)
Oral
100
5
Stelazine

Triglycerides Oil - Medium Chain
500 mL
Oral
2
5
MCT Oil

Trimethoprim
Tablet 300 mg
Oral
7
1
Alprim
Triprim

Trimethoprim with Sulfamethoxazole
Tablet 80 mg-400 mg
Oral
10
1
Resprim
Septrin

 
Tablet 160 mg-800 mg
Oral
10
1
Bactrim DS

 
 
 
 
 
Chem mart Trimethoprim with Sulfamethoxazole DS

 
 
 
 
 
GenRx Trimethoprim with Sulfamethoxazole DS

 
 
 
 
 
Resprim Forte

 
 
 
 
 
Septrin Forte

 
 
 
 
 
Terry White Chemists Trimethoprim with Sulfamethoxazole DS

 
Paediatric oral suspension 40 mg-200 mg per 5 mL, 100 mL
Oral
1
1
Bactrim
Resprim
Septrin

Tropisetron
Capsule 5 mg (as hydrochloride)
Oral
2
..
Navoban

 
I.V. injection 5 mg (as hydrochloride) in 5 mL
Injection
1
..
Navoban

"TYR Express"
Sachets containing oral powder 25 g, 30
Oral
4
5
TYR Express

"TYR gel"
Sachets containing oral powder 20 g, 30
Oral
4
5
TYR gel

Ursodeoxycholic Acid
Capsule 250 mg
Oral
100
2
Ursofalk

Valaciclovir
Tablet 500 mg (as hydrochloride)
Oral
20
..
Valtrex

Valproic Acid
Tablet, crushable, containing sodium valproate 100 mg
Oral
200
2
Epilim

 
Tablet (enteric coated) containing sodium valproate 200 mg
Oral
200
2
Epilim EC
Valpro 200
Valproate Winthrop EC 200

 
Tablet (enteric coated) containing sodium valproate 500 mg
Oral
200
2
Epilim EC
Valpro 500
Valproate Winthrop EC 500

 
Oral liquid containing sodium valproate 200 mg per 5 mL, 300 mL
Oral
2
2
Epilim Liquid

 
Oral solution containing sodium valproate 200 mg per 5 mL, 300 mL
Oral
2
2
Epilim Syrup

Vancomycin
Capsule 125 mg (125,000 I.U.) (as hydrochloride)
Oral
40
..
Vancocin

 
Capsule 250 mg (250,000 I.U.) (as hydrochloride)
Oral
40
..
Vancocin

 
Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)
Injection
2
..
Mayne Pharma Pty Ltd
Vancocin

Venlafaxine
Capsule (modified release) 37.5 mg (as hydrochloride)
Oral
28
..
Efexor-XR

 
Capsule (modified release) 75 mg (as hydrochloride)
Oral
28
5
Efexor-XR

 
Capsule (modified release) 150 mg (as hydrochloride)
Oral
28
5
Efexor-XR

Verapamil
Tablet containing verapamil hydrochloride 40 mg
Oral
100
5
Anpec 40
Isoptin

 
Tablet containing verapamil hydrochloride 80 mg
Oral
100
5
Anpec 80
Isoptin

 
Tablet containing verapamil hydrochloride 120 mg
Oral
100
5
Isoptin

 
Tablet containing verapamil hydrochloride 160 mg
Oral
60
5
Isoptin

 
Tablet containing verapamil hydrochloride 180 mg (sustained release)
Oral
30
5
Cordilox 180 SR
Isoptin 180 SR

 
Tablet containing verapamil hydrochloride 240 mg (sustained release)
Oral
30
5
Anpec SR
Cordilox SR
Isoptin SR

 
Capsule containing verapamil hydrochloride 160 mg (sustained release)
Oral
30
5
Veracaps SR

 
Capsule containing verapamil hydrochloride 240 mg (sustained release)
Oral
30
5
Veracaps SR

 
Injection containing verapamil hydrochloride 5 mg in 2 mL
Injection
5
..
Isoptin

Verteporfin
Powder for I.V. infusion 15 mg
Injection
1
..
Visudyne

Vigabatrin
Tablet 500 mg
Oral
100
5
Sabril

 
Oral powder, sachet 500 mg
Oral
60
5
Sabril

Vinblastine
Solution for I.V. injection containing vinblastine sulfate 10 mg in 10 mL
Injection
5
..
Mayne Pharma Pty Ltd

Vincristine
I.V. injection containing vincristine sulfate 1 mg in 1 mL
Injection
10
..
Mayne Pharma Pty Ltd
Pfizer Pty Limited

Vinorelbine
Capsule 20 mg (as tartrate)
Oral
20
2
Navelbine

 
Capsule 30 mg (as tartrate)
Oral
16
2
Navelbine

 
Solution for I.V. infusion 10 mg (as tartrate) in 1 mL
Injection
16
2
Mayne Pharma Pty Ltd
Navelbine
Vinorelbine Ebewe

 
Solution for I.V. infusion 50 mg (as tartrate) in 5 mL
Injection
4
2
Mayne Pharma Pty Ltd
Navelbine
Vinorelbine Ebewe

Warfarin
Tablet containing warfarin sodium 1 mg
Oral
50
2
Coumadin
Marevan

 
Tablet containing warfarin sodium 2 mg
Oral
50
2
Coumadin

 
Tablet containing warfarin sodium 3 mg
Oral
50
2
Marevan

 
Tablet containing warfarin sodium 5 mg
Oral
50
2
Coumadin
Marevan

"XLYS, LOW TRY Analog"
Oral powder 400 g
Oral
8
5
XLYS, LOW TRY Analog

"XLYS, LOW TRY Maxamaid"
Oral powder 500 g
Oral
8
5
XLYS, LOW TRY Maxamaid

"XMET Analog"
Oral powder 400 g
Oral
8
5
XMET Analog

"XMET Maxamaid"
Oral powder 500 g
Oral
8
5
XMET Maxamaid

"XMET Maxamum"
Oral powder 500 g
Oral
8
5
XMET Maxamum

"XMTVI Analog"
Oral powder 400 g
Oral
8
5
XMTVI Analog

"XMTVI Asadon"
Oral powder 200 g
Oral
5
5
XMTVI Asadon

"XMTVI Maxamaid"
Oral powder 500 g
Oral
8
5
XMTVI Maxamaid

"XMTVI Maxamum"
Oral powder 500 g
Oral
8
5
XMTVI Maxamum

"XP Analog"
Oral powder 400 g
Oral
8
5
XP Analog

"XP Analog LCP"
Oral powder 400 g
Oral
8
5
XP Analog LCP

"XPhen, Tyr Analog"
Oral powder 400 g
Oral
8
5
XPhen, Tyr Analog

"XPhen, Tyr Maxamaid"
Oral powder 500 g
Oral
8
5
XPhen, Tyr Maxamaid

"XPhen, Tyr Maxamum"
Oral powder 500 g
Oral
8
5
XPhen, Tyr Maxamum

"XP Maxamaid"
Oral powder 500 g
Oral
8
5
XP Maxamaid

"XP Maxamum"
Sachets containing oral powder 50 g, 30
Oral
3
5
XP Maxamum

 
Oral powder 500 g
Oral
8
5
XP Maxamum

"XPTM Tyrosidon"
Oral powder 500 g
Oral
4
5
XPTM Tyrosidon

Ziprasidone
Capsule 20 mg (as hydrochloride)
Oral
60
5
Zeldox

 
Capsule 40 mg (as hydrochloride)
Oral
60
5
Zeldox

 
Capsule 60 mg (as hydrochloride)
Oral
60
5
Zeldox

 
Capsule 80 mg (as hydrochloride)
Oral
60
5
Zeldox

Zolmitriptan
Tablet 2.5 mg
Oral
4
5
Zomig

Zuclopenthixol Decanoate
Oily I.M. injection 200 mg in 1 mL ampoule
Injection
5
..
Clopixol Depot


Aciclovir
Tablet 200 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis
Oral
90
5
Aciclovir 200
Acihexal
Acyclo-V 200
Chem mart Aciclovir
GenRx Aciclovir
Lovir
Ozvir
Terry White Chemists Aciclovir
Zovirax 200 mg

 
 
 
 
 
 
 

 
 
 
 
 
 
 

 
 
 
 
 
 
 

 
 
 
 
 
 
 

 
 
 
 
 
 
 

 
Tablet 800 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Patients with advanced human immunodeficiency virus disease (CD4 cell counts of less than 150 million per L)
Oral
120
5
Acihexal
Acyclo-V 800
Lovir
Zovirax 800 mg

Adalimumab
Injection 40 mg in 0.8 mL pre-filled syringe
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing treatment with adalimumab within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
Injection
2
5
Humira

 
 
 
 (a) who have a documented history of severe active rheumatoid arthritis; and
 
 
 
 

 
 
 
 (b) who have demonstrated an adequate response to treatment with adalimumab; and
 
 
 
 

 
 
 
 (c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with adalimumab; and
 
 
 
 

 
 
 
 where bDMARD means adalimumab, anakinra, etanercept, infliximab or rituximab; and
 
 
 
 

 
 
 
 where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 patients who commenced PBS-subsidised bDMARD treatment prior to 1 August 2007 are deemed to have commenced their first bDMARD treatment cycle with that therapy;
 
 
 
 

 
 
 
 an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
 
 
 
 

 
 
 
 a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
 
 
 
 

 
 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and
 
 
 
 

 
 
 
 (b) if the course of therapy is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;
 
 
 
 

 
 
 
 if the most recent course of adalimumab therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
 
 
 
 

 
 
 
 the patient has not failed to demonstrate response to a course of PBS-subsidised adalimumab in this Treatment Cycle;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
Injection 40 mg in 0.8 mL pre-filled syringe
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
Injection
2
3
Humira

 
 
 
 (1) have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and
 
 
 
 

 
 
 
 (2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and
 
 
 
 

 
 
 
 (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with either methotrexate or sulfasalazine, at an adequate dose, for a minimum of 3 months; and
 
 
 
 

 
 
 
 (4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and
 
 
 
 

 
 
 
 (5) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
 
 
 
 

 
 
 
 if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
 
 
 
 

 
 
 
 if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form;
 
 
 
 

 
 
 
 a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment, or recommencement of treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
 
 
 
 

 
 
 
 (1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and
 
 
 
 

 
 
 
 (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and
 
 
 
 

 
 
 
 (3) have not failed treatment with adalimumab during the current Treatment Cycle; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle;
 
 
 
 

 
 
 
 patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if:
 
 
 
 

 
 
 
 (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with adalimumab, to their most recent course of PBS-subsidised adalimumab treatment; and
 
 
 
 

 
 
 
 (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and
 
 
 
 

 
 
 
 (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and
 
 
 
 

 
 
 
 (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form;
 
 
 
 

 
 
 
 a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
Injection 40 mg in 0.8 mL pre-filled syringe
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
Injection
2
5
Humira

 
 
 
 (1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and
 
 
 
 

 
 
 
 (2) were receiving treatment with adalimumab prior to 16 March 2006; and
 
 
 
 

 
 
 
 (3) have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and
 
 
 
 

 
 
 
 (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgment form;
 
 
 
 

 
 
 
 the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight;
 
 
 
 

 
 
 
 patients are eligible for PBS-subsidised treatment under the above criteria once only
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults:
 
 
 
 

 
 
 
 (1) who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status; and
 
 
 
 

 
 
 
 (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with adalimumab; and
 
 
 
 

 
 
 
 (3) who, at the time of application, demonstrate an adequate response to treatment with adalimumab; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 an adequate response to treatment with adalimumab is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;
 
 
 
 

 
 
 
 if the most recent course of adalimumab therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
Injection 40 mg in 0.8 mL pre-filled syringe
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:
Injection
2
3
Humira

 
 
 
 (a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with one of these drugs, has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and
 
 
 
 

 
 
 
 (b) who has at least 2 of the following:
 
 
 
 

 
 
 
 (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or
 
 
 
 

 
 
 
 (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or
 
 
 
 

 
 
 
 (iii) limitation of chest expansion relative to normal values for age and gender; and
 
 
 
 

 
 
 
 (c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and
 
 
 
 

 
 
 
 (d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
 
 
 
 

 
 
 
 where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 failure to achieve an adequate response is demonstrated by:
 
 
 
 

 
 
 
 (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and
 
 
 
 

 
 
 
 (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L;
 
 
 
 

 
 
 
 both ESR and CRP measurements are included in the authority application and are no more than 1 month old;
 
 
 
 

 
 
 
 if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied;
 
 
 
 

 
 
 
 the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;
 
 
 
 

 
 
 
 if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used;
 
 
 
 

 
 
 
 if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication;
 
 
 
 

 
 
 
 if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;
 
 
 
 

 
 
 
 an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;
 
 
 
 

 
 
 
 if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;
 
 
 
 

 
 
 
 the application for authorisation includes:
 
 
 
 

 
 
 
 (a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
 
 
 
 

 
 
 
 (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
 
 
 
 

 
 
 
 (ii) a completed BASDAI Assessment Form; and
 
 
 
 

 
 
 
 (iii) a signed patient acknowledgment form; and
 
 
 
 

 
 
 
 (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;
 
 
 
 

 
 
 
 a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS-subsidised therapy with adalimumab; and
 
 
 
 

 
 
 
 where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 a patient who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment;
 
 
 
 

 
 
 
 the application is accompanied by the results of the patient's most recent course of PBS-subsidised adalimumab, etanercept or infliximab therapy, where:
 
 
 
 

 
 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and
 
 
 
 

 
 
 
 (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or
 
 
 
 

 
 
 
 (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;
 
 
 
 

 
 
 
 if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;
 
 
 
 

 
 
 
 a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
Injection 40 mg in 0.8 mL pre-filled syringe
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who was receiving treatment with adalimumab prior to 1 November 2006; and
Injection
2
5
Humira

 
 
 
 (a) who is receiving treatment with adalimumab at the time of application; and
 
 
 
 

 
 
 
 (b) who has not received prior PBS-subsidised treatment with infliximab or etanercept; and
 
 
 
 

 
 
 
 (c) whose current Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score is either less than or equal to 5 on a 0-10 scale or improved by at least 2 from baseline; and
 
 
 
 

 
 
 
 (d) who has:
 
 
 
 

 
 
 
 (i) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or
 
 
 
 

 
 
 
 (ii) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or
 
 
 
 

 
 
 
 (iii) an ESR or CRP measurement reduced by at least 20% from pre-treatment baseline; and
 
 
 
 

 
 
 
 (e) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
 
 
 
 

 
 
 
 where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 the BASDAI assessment and the ESR and CRP measurements provided are no more than 1 month old at the time of application;
 
 
 
 

 
 
 
 the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
 
 
 
 

 
 
 
 (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
 
 
 
 

 
 
 
 (ii) a completed BASDAI Assessment Form; and
 
 
 
 

 
 
 
 (iii) a signed patient acknowledgment form;
 
 
 
 

 
 
 
 the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight;
 
 
 
 

 
 
 
 patients are eligible for PBS-subsidised treatment under the above criteria once only
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who was receiving non-PBS-subsidised treatment with adalimumab prior to 1 November 2006 and at the time of the initial application for PBS-subsidised therapy and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with adalimumab, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with adalimumab; and
 
 
 
 

 
 
 
 where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 a patient who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;
 
 
 
 

 
 
 
 response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:
 
 
 
 

 
 
 
 (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or
 
 
 
 

 
 
 
 (b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or
 
 
 
 

 
 
 
 (c) an ESR or CRP measurement reduced by at least 20% from baseline;
 
 
 
 

 
 
 
 if the patient commenced treatment with adalimumab prior to 1 November 2006, was subsequently commenced on PBS-subsidised treatment and is continuing to receive PBS-subsidised treatment in their first treatment cycle, and where pre-treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, or no greater than 2, and 1 of the following:
 
 
 
 

 
 
 
 (a) an ESR measurement no greater than 25 mm per hour; or
 
 
 
 

 
 
 
 (b) a CRP measurement no greater than 10 mg per L;
 
 
 
 

 
 
 
 all measurements provided are no more than 1 month old at the time of application;
 
 
 
 

 
 
 
 the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient;
 
 
 
 

 
 
 
 patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
 
 
 
 

 
 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and
 
 
 
 

 
 
 
 (b) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment;
 
 
 
 

 
 
 
 the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
 
 
 
 

Adrenaline
I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector
 
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years who has been assessed to be at significant risk of anaphylaxis by, or in consultation with, a clinical immunologist, allergist, paediatrician or respiratory physician, where a quantity of 2 adrenaline auto-injectors is necessary to ensure 1 is on hand at all times, and where the name of the specialist consulted is included in the authority application
Injection
2
..
EpiPen Jr.

 
 
 
Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years who has been discharged from hospital or an emergency department after treatment with adrenaline for acute allergic reaction with anaphylaxis, where a quantity of 2 adrenaline auto-injectors is necessary to ensure 1 is on hand at all times
 
 
 
 

 
 
 
Continuing supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years, where a quantity of 2 adrenaline auto-injectors is necessary to ensure 1 is on hand at all times, and where the patient has previously been issued with an authority prescription for this drug
 
 
 
 

 
I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector
 
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years who has been assessed to be at significant risk of anaphylaxis by, or in consultation with, a clinical immunologist, allergist, paediatrician or respiratory physician, where a quantity of 2 adrenaline auto-injectors is necessary to ensure 1 is on hand at all times, and where the name of the specialist consulted is included in the authority application
Injection
2
..
EpiPen

 
 
 
Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years who has been discharged from hospital or an emergency department after treatment with adrenaline for acute allergic reaction with anaphylaxis, where a quantity of 2 adrenaline auto-injectors is necessary to ensure 1 is on hand at all times
 
 
 
 

 
 
 
Continuing supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years, where a quantity of 2 adrenaline auto-injectors is necessary to ensure 1 is on hand at all times, and where the patient has previously been issued with an authority prescription for this drug
 
 
 
 

Albendazole
Tablet 200 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Oral
6
1
Zentel

 
 
1525
 Treatment of tapeworm infestation
 
 
 
 

Amoxycillin
Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL
 
In compliance with authority procedures set out in subparagraph 11 (d):
Treatment of infections suspected or proven to be due to a susceptible organism in patients who require a liquid formulation and in whom the syrup formulations are unsuitable
Oral
1
1
Amoxil

Anakinra
Injection 100 mg in 0.67 mL single use pre-filled syringe
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing treatment with anakinra within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
Injection
28
5
Kineret

 
 
 
 (a) who have a documented history of severe active rheumatoid arthritis; and
 
 
 
 

 
 
 
 (b) who have demonstrated an adequate response to treatment with anakinra; and
 
 
 
 

 
 
 
 (c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with anakinra; and
 
 
 
 

 
 
 
 where bDMARD means adalimumab, anakinra, etanercept, infliximab or rituximab; and
 
 
 
 

 
 
 
 where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly;
 
 
 
 

 
 
 
 patients who commenced PBS-subsidised bDMARD treatment prior to 1 August 2007 are deemed to have commenced their first bDMARD treatment cycle with that therapy;
 
 
 
 

 
 
 
 an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
 
 
 
 

 
 
 
 a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
 
 
 
 

 
 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and
 
 
 
 

 
 
 
 (b) if the course of therapy is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with anakinra, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;
 
 
 
 

 
 
 
 if the most recent course of anakinra therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
 
 
 
 

 
 
 
 the patient has not failed to demonstrate response to a course of PBS-subsidised anakinra in this Treatment Cycle;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

Azithromycin
Tablet 500 mg (as dihydrate)
 
Trachoma
Oral
2
2
Zithromax

Benzathine Penicillin
Injection 900 mg in 2 mL cartridge-needle unit (for use with Tubex Injector)
 
Syphilis
Injection
2
..
Bicillin L-A Tubex

 
Powder for injection 900 mg
 
Syphilis
Injection
2
..
Pan Benzathine Benzylpenicillin

Bromocriptine
Tablet 2.5 mg (as mesylate)
 
Acromegaly
Parkinson's disease
Oral
60
5
Kripton 2.5
Parlodel

 
 
 
Pathological hyperprolactinaemia where surgery is not indicated
 
 
 
 

 
 
 
Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution
 
 
 
 

 
 
 
Pathological hyperprolactinaemia where radiotherapy is not indicated
 
 
 
 

 
 
 
Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution
 
 
 
 

Buprenorphine
Transdermal patch 5 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Transdermal
4
..
Norspan

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Transdermal patch 10 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Transdermal
4
..
Norspan

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Transdermal patch 20 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Transdermal
4
..
Norspan

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

Bupropion
Tablet containing bupropion hydrochloride 150 mg (sustained release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Completion of treatment as short-term adjunctive therapy for nicotine dependence to facilitate the goal of achieving abstinence in patients who have indicated that they are ready to cease smoking and who have entered a comprehensive support and counselling program, and where the patient has previously been issued with an authority prescription for commencement of treatment with this drug
Oral
90
..
Bupropion-RL
Clorprax
Prexaton
Zyban

Cabergoline
Tablet 500 micrograms
 
In compliance with authority procedures set out in subparagraph 11 (d):
Oral
8
5
Dostinex

 
 
2659
 Pathological hyperprolactinaemia where surgery is not indicated
 
 
 
 

 
 
2660
 Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution
 
 
 
 

 
 
2661
 Pathological hyperprolactinaemia where radiotherapy is not indicated
 
 
 
 

 
 
2662
 Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution
 
 
 
 

Ceftriaxone
Powder for injection 500 mg (as sodium)
 
Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Septicaemia, suspected
Septicaemia, proven
Injection
5
..
Ceftriaxone ICP

Chorionic Gonadotrophin
Injection set containing 3 ampoules powder for injection 500 units and 3 ampoules solvent 1 mL
 
Cryptorchism not due to organic obstruction in boys over 12 months of age
Injection
2
1
Pregnyl

Ciprofloxacin
Tablet 250 mg (as hydrochloride)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Respiratory tract infection proven or suspected to be caused by  Bacterial gastroenteritis in severely immunocompromised patients
Treatment of infections proven to be due to Pseudomonas aeruginosa or other gram-negative bacteria resistant to all other oral antimicrobials
Oral
14
..
C-Flox 250
Ciprofloxacin-BC
Ciprol 250
Ciproxin 250
GenRx Ciprofloxacin
Profloxin

 
 
 
Treatment of joint and bone infections, epididymo-orchitis, prostatitis or perichondritis of the pinna, suspected or proven to be caused by gram-negative bacteria or gram-positive bacteria resistant to all other appropriate antimicrobials
 
 
 
 

Codeine with Paracetamol
Tablet containing codeine phosphate 30 mg with paracetamol 500 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Treatment (for up to 6 months) of severe disabling pain not responding to non-narcotic analgesics, at a dose not exceeding 8 tablets per day
Oral
60
..
Codalgin Forte
Codapane Forte
Dolaforte
Dymadon Forte
Panadeine Forte
Prodeine Forte

 
 
 
 
 
 
 

 
 
 
 
 
 
 

Cyproterone
Tablet containing cyproterone acetate 50 mg
                                 
                        1014
1404
In compliance with authority procedures set out in subparagraph 11 (d):
 Advanced carcinoma of the prostate
 To reduce drive in sexual deviations in males
Oral
100
5
Androcur
Cyprohexal
Cyprone
Cyprostat
GenRx Cyproterone Acetate
Procur

 
 
 
 
 

 
 
 
 
 

 
 
 
 
 

Dalteparin
Injection containing dalteparin sodium 2,500 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe
 
Haemodialysis
Injection
20
3
Fragmin

 
Injection containing dalteparin sodium 5,000 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe
 
Haemodialysis
Injection
20
3
Fragmin

 
Injection containing dalteparin sodium 7,500 I.U. (anti-Xa) in 0.75 mL single dose pre-filled syringe
 
Haemodialysis
Injection
20
3
Fragmin

Desmopressin
Tablet containing desmopressin acetate 200 micrograms
                   
                   1678
In compliance with authority procedures set out in subparagraph 11 (d):
 Cranial diabetes insipidus
Oral
90
5
Minirin

 
Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 60 actuations, 6 mL
 
                   1678
 
 
In compliance with authority procedures set out in subparagraph 11 (d):
Cranial diabetes insipidus
 
 
Nasal
2
5
Minirin Nasal Spray

Diazepam
Tablet 2 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Disabling spasticity
Malignant neoplasia (late stage)
Oral
100
..
Antenex 2
Ducene
Valium
Valpam 2

 
 
 
For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
 
 
 
 

 
 
 
For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
 
 
 
 

 
Tablet 5 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Disabling spasticity
Malignant neoplasia (late stage)
For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
Oral
100
..
Antenex 5
Diazepam-DP
Ducene
Valium
Valpam 5

 
 
 
 
 
 
 

 
 
 
For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
 
 
 
 

"Digestelact"
Oral powder 900 g
 
In compliance with authority procedures set out in subparagraph 11 (d):
Proven chronic lactose intolerance in children aged 1 year and over who are significantly malnourished, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet
Oral
3
10
Digestelact

Doxycycline
Tablet 100 mg (as hydrochloride)
 
Pelvic inflammatory disease
Oral
28
..
Doxsig
Doxy-100
Doxylin 100
Vibramycin

 
 
 
 
 
 
 

 
 
 
 
 
 
 

 
Tablet 100 mg (as hydrochloride)
 
Urethritis
Oral
21
..
Doxsig
Doxy-100

 
 
 
 
 
 
 
Doxylin 100

 
 
 
 
 
 
 
Vibramycin

 
Tablet 100 mg (as monohydrate)
 
Pelvic inflammatory disease
Oral
28
..
Chem mart Doxycycline

 
 
 
 
 
 
 
Doxyhexal

 
 
 
 
 
 
 
GenRx Doxycycline

 
 
 
 
 
 
 
Terry White Chemists Doxycycline

 
Tablet 100 mg (as monohydrate)
 
Urethritis
Oral
21
..
Chem mart Doxycycline

 
 
 
 
 
 
 
Doxyhexal

 
 
 
 
 
 
 
GenRx Doxycycline

 
 
 
 
 
 
 
Terry White Chemists Doxycycline

 
Capsule 100 mg (as hydrochloride) (containing enteric coated pellets)
 
Pelvic inflammatory disease
Oral
28
..
DBL Doxycycline
Doryx

 
Capsule 100 mg (as hydrochloride) (containing enteric coated pellets)
 
Urethritis
Oral
21
..
DBL Doxycycline
Doryx

Efalizumab
Injection set containing 4 vials powder for injection 125 mg and 4 pre-filled syringes diluent 1.3 mL
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Commencement of a Biological Treatment Cycle with an initial PBS-subsidised course of efalizumab for continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin) by a dermatologist for adults 18 years and over who:
Injection
1
5
Raptiva

 
 
 
 (a) have a documented history of severe chronic plaque psoriasis and were receiving treatment with efalizumab prior to 10 November 2005; and
 
 
 
 

 
 
 
 (b) had a Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing treatment with efalizumab; and
 
 
 
 

 
 
 
 (c) have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and
 
 
 
 

 
 
 
 (d) have demonstrated a response as specified in the criterion included in the relevant restriction for continuing PBS-subsidised treatment with efalizumab; and
 
 
 
 

 
 
 
 where biological agent means efalizumab or etanercept; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
 
 
 
 

 
 
 
 (i) a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and whole body area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of efalizumab therapy) and the most recent PASI assessment; and
 
 
 
 

 
 
 
 (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
 
 
 
 

 
 
 
 (iii) a copy of the signed patient acknowledgement form;
 
 
 
 

 
 
 
 the most recent PASI assessment is no more than 1 month old at the time of application;
 
 
 
 

 
 
 
 the course of treatment is limited to a maximum of 24 weeks of treatment;
 
 
 
 

 
 
 
 patients are eligible for PBS-subsidised treatment under the above criteria once only
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of a course of initial PBS-subsidised treatment as systemic monotherapy, commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis, who were receiving non-PBS-subsidised treatment with efalizumab prior to 10 November 2005, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
 
 
 
 

 
 
 
 (a) who have a documented history of severe chronic plaque psoriasis; and
 
 
 
 

 
 
 
 (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with efalizumab; and
 
 
 
 

 
 
 
 (c) who have demonstrated an adequate response to their most recent course of treatment with efalizumab; and
 
 
 
 

 
 
 
 where biological agent means efalizumab or etanercept; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 an adequate response to efalizumab treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, after at least 12 weeks of efalizumab treatment, when compared with the baseline value for this Treatment Cycle established prior to biological agent treatment;
 
 
 
 

 
 
 
 the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score;
 
 
 
 

 
 
 
 patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
 
 
 
 

 
 
 
 (i) the assessment of response is conducted following at least 12 weeks of therapy, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course; and
 
 
 
 

 
 
 
 (ii) the response assessment is submitted to the Medicare Australia CEO no later than 1 month from the date that course of treatment ceased;
 
 
 
 

 
 
 
 the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and whole body area diagrams along with the date of the assessment of the patient's condition;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Commencement of a Biological Treatment Cycle with an initial PBS-subsidised course of efalizumab for continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin) by a dermatologist for adults 18 years and over:
 
 
 
 

 
 
 
 (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and were receiving treatment with efalizumab prior to 10 November 2005; and
 
 
 
 

 
 
 
 (b) whose disease, prior to treatment with efalizumab, was classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where either at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling were rated as severe or very severe, or the skin area affected was 30% or more of the face, palm of a hand or sole of a foot; and
 
 
 
 

 
 
 
 (c) who have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and
 
 
 
 

 
 
 
 (d) who have demonstrated a response as specified in the criterion included in the relevant restriction for continuing PBS-subsidised treatment with efalizumab; and
 
 
 
 

 
 
 
 where biological agent means efalizumab or etanercept; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
 
 
 
 

 
 
 
 (i) a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of efalizumab therapy) and the most recent PASI assessment; and
 
 
 
 

 
 
 
 (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
 
 
 
 

 
 
 
 (iii) a copy of the signed patient acknowledgement form;
 
 
 
 

 
 
 
 the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score;
 
 
 
 

 
 
 
 the most recent PASI assessment is no more than 1 month old at the time of application;
 
 
 
 

 
 
 
 the course of treatment is limited to a maximum of 24 weeks of treatment;
 
 
 
 

 
 
 
 patients are eligible for PBS-subsidised treatment under the above criteria once only
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of a course of initial PBS-subsidised treatment as systemic monotherapy, commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, who were receiving non-PBS-subsidised treatment with efalizumab prior to 10 November 2005, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
 
 
 
 

 
 
 
 (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
 
 
 
 

 
 
 
 (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with efalizumab; and
 
 
 
 

 
 
 
 (c) who have demonstrated an adequate response to their most recent course of treatment with efalizumab; and
 
 
 
 

 
 
 
 where biological agent means efalizumab or etanercept; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 an adequate response to efalizumab treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing:
 
 
 
 

 
 
 
 (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, after at least 12 weeks of efalizumab treatment, as compared to the baseline values established prior to biological agent treatment; or
 
 
 
 

 
 
 
 (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, after at least 12 weeks of efalizumab treatment, as compared to the baseline value established prior to biological agent treatment;
 
 
 
 

 
 
 
 the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score;
 
 
 
 

 
 
 
 patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
 
 
 
 

 
 
 
 (i) the assessment of response is conducted following at least 12 weeks of therapy, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course; and
 
 
 
 

 
 
 
 (ii) the response assessment is submitted to the Medicare Australia CEO no later than 1 month from the date that course of treatment ceased;
 
 
 
 

 
 
 
 the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

"EleCare"
Oral powder 400 g
 
In compliance with authority procedures set out in subparagraph 11 (d):
Continuing treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
Oral
8
5
EleCare

 
 
 
Treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged 2 years or over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
 
 
 
 

 
 
 
Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed
 
 
 
 

 
 
 
Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition
 
 
 
 

Enoxaparin
Injection containing enoxaparin sodium 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre-filled syringe
 
Haemodialysis
Injection
20
3
Clexane

 
Injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in 0.4 mL pre-filled syringe
 
Haemodialysis
Injection
20
3
Clexane

 
Injection containing enoxaparin sodium 60 mg (6,000 I.U. anti-Xa) in 0.6 mL pre-filled syringe
 
Haemodialysis
Injection
20
3
Clexane

Escitalopram
Oral solution 10 mg (as oxalate) per mL, 28 mL
 
In compliance with authority procedures set out in subparagraph 11 (d):
Major depressive disorders, where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
Oral
1
5
Lexapro

 
 
 
Major depressive disorders, where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Major depressive disorders, where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Major depressive disorders, where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
 
 
 
 

 
 
 
Major depressive disorders, where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
 
 
 
 

Esomeprazole
Tablet (enteric coated) 20 mg (as magnesium trihydrate)
 
Maintenance of healed gastro-oesophageal reflux disease
Oral
30
5
Nexium

Etanercept
Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:
Injection
2
3
Enbrel

 
 
 
 (a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with one of these drugs, has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and
 
 
 
 

 
 
 
 (b) who has at least 2 of the following:
 
 
 
 

 
 
 
 (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or
 
 
 
 

 
 
 
 (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or
 
 
 
 

 
 
 
 (iii) limitation of chest expansion relative to normal values for age and gender; and
 
 
 
 

 
 
 
 (c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and
 
 
 
 

 
 
 
 (d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
 
 
 
 

 
 
 
 where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 failure to achieve an adequate response is demonstrated by:
 
 
 
 

 
 
 
 (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and
 
 
 
 

 
 
 
 (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L;
 
 
 
 

 
 
 
 both ESR and CRP measurements are included in the authority application and are no more than 1 month old;
 
 
 
 

 
 
 
 if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied;
 
 
 
 

 
 
 
 the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;
 
 
 
 

 
 
 
 if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used;
 
 
 
 

 
 
 
 if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication;
 
 
 
 

 
 
 
 if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;
 
 
 
 

 
 
 
 an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;
 
 
 
 

 
 
 
 if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;
 
 
 
 

 
 
 
 the application for authorisation includes:
 
 
 
 

 
 
 
 (a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
 
 
 
 

 
 
 
 (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
 
 
 
 

 
 
 
 (ii) a completed BASDAI Assessment Form; and
 
 
 
 

 
 
 
 (iii) a signed patient acknowledgment form; and
 
 
 
 

 
 
 
 (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;
 
 
 
 

 
 
 
 a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS-subsidised therapy with etanercept; and
 
 
 
 

 
 
 
 where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 a patient who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment;
 
 
 
 

 
 
 
 the application is accompanied by the results of the patient's most recent course of PBS-subsidised adalimumab, etanercept or infliximab therapy, where:
 
 
 
 

 
 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and
 
 
 
 

 
 
 
 (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or
 
 
 
 

 
 
 
 (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;
 
 
 
 

 
 
 
 if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;
 
 
 
 

 
 
 
 a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with etanercept, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with etanercept; and
Injection
2
5
Enbrel

 
 
 
 where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 a patient who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;
 
 
 
 

 
 
 
 response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:
 
 
 
 

 
 
 
 (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or
 
 
 
 

 
 
 
 (b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or
 
 
 
 

 
 
 
 (c) an ESR or CRP measurement reduced by at least 20% from baseline;
 
 
 
 

 
 
 
 if the patient commenced treatment with etanercept prior to 1 July 2004, was commenced on PBS-subsidised treatment prior to 1 March 2007 and is continuing to receive PBS-subsidised treatment in their first treatment cycle, and where pre-treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, or no greater than 2, and 1 of the following:
 
 
 
 

 
 
 
 (a) an ESR measurement no greater than 25 mm per hour; or
 
 
 
 

 
 
 
 (b) a CRP measurement no greater than 10 mg per L;
 
 
 
 

 
 
 
 all measurements provided are no more than 1 month old at the time of application;
 
 
 
 

 
 
 
 the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient;
 
 
 
 

 
 
 
 patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
 
 
 
 

 
 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and
 
 
 
 

 
 
 
 (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or
 
 
 
 

 
 
 
 (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;
 
 
 
 

 
 
 
 the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

 
Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
 (1) have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and
Injection
2
3
Enbrel

 
 
 
 
 
 
 

 
 
 
 (2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and
 
 
 
 

 
 
 
 (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to achieve an adequate response to treatment with either methotrexate or sulfasalazine, at an adequate dose, for a minimum of 3 months; and
 
 
 
 

 
 
 
 (4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and
 
 
 
 

 
 
 
 (5) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
 
 
 
 

 
 
 
 if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
 
 
 
 

 
 
 
 if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form;
 
 
 
 

 
 
 
 a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment, or recommencement of treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
 
 
 
 

 
 
 
 (1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and
 
 
 
 

 
 
 
 (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and
 
 
 
 

 
 
 
 (3) have not failed treatment with etanercept during the current Treatment Cycle; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle;
 
 
 
 

 
 
 
 patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if:
 
 
 
 

 
 
 
 (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with etanercept, to their most recent course of PBS-subsidised etanercept treatment; and
 
 
 
 

 
 
 
 (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and
 
 
 
 

 
 
 
 (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and
 
 
 
 

 
 
 
 (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form;
 
 
 
 

 
 
 
 a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of etanercept for continuing treatment, by a rheumatologist or by an immunologist with expertise in the management of psoriatic arthritis, of adults who:
Injection
2
5
Enbrel

 
 
 
 (1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and
 
 
 
 

 
 
 
 (2) were receiving treatment with etanercept prior to 17 March 2005; and
 
 
 
 

 
 
 
 (3) have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and
 
 
 
 

 
 
 
 (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgement form;
 
 
 
 

 
 
 
 the course of treatment is limited to a maximum of 24 weeks of treatment;
 
 
 
 

 
 
 
 patients are eligible for PBS-subsidised treatment under the above criteria once only
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing treatment within an ongoing Biological Treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults:
 
 
 
 

 
 
 
 (1) who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status; and
 
 
 
 

 
 
 
 (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with etanercept; and
 
 
 
 

 
 
 
 (3) who, at the time of application, demonstrate an adequate response to treatment with etanercept; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 an adequate response to treatment with etanercept is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;
 
 
 
 

 
 
 
 if the most recent course of etanercept therapy was a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

 
Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Initial treatment commencing a biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
Injection
2
3
Enbrel

 
 
 
(a) have severe active rheumatoid arthritis; and
 
 
 
 

 
 
 
(b) have not previously received PBS-subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS-subsidised treatment with a bDMARD for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised bDMARD treatment for this condition was approved; and
 
 
 
 

 
 
 
(c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and
 
 
 
 

 
 
 
where bDMARD means adalimumab, anakinra, etanercept, infliximab or rituximab; and
 
 
 
 

 
 
 
where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
where the following conditions apply:
 
 
 
 

 
 
 
failure to achieve an adequate response to the treatment regimens specified at (c) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:
 
 
 
 

 
 
 
— elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
— shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
 
 
 
 

 
 
 
if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
 
 
 
 

 
 
 
if intolerance to treatment with the regimens specified at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
 
 
 
 

 
 
 
the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a signed patient acknowledgment;
 
 
 
 

 
 
 
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Continuation of initial treatment in a bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Initial treatment, or recommencement of treatment, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
 
 
 
 

 
 
 
(a) have a documented history of severe active rheumatoid arthritis; and
 
 
 
 

 
 
 
(b) have received prior PBS-subsidised treatment with a bDMARD for this condition in this Treatment Cycle and who are eligible to receive further bDMARD therapy within this Treatment Cycle; and
 
 
 
 

 
 
 
(c) have not failed previous PBS-subsidised treatment with etanercept during this Treatment Cycle; and
 
 
 
 

 
 
 
where bDMARD means adalimumab, anakinra, etanercept, infliximab or rituximab; and
 
 
 
 

 
 
 
where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
where the following conditions apply:
 
 
 
 

 
 
 
patients who commenced PBS-subsidised bDMARD treatment prior to 1 August 2007 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy;
 
 
 
 

 
 
 
patients are eligible to receive further bDMARD therapy within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this Treatment Cycle;
 
 
 
 

 
 
 
patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this bDMARD Treatment Cycle are eligible to recommence therapy with this drug within this same cycle provided that:
 
 
 
 

 
 
 
(i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment of rheumatoid arthritis, to their most recent course of PBS-subsidised etanercept treatment; and
 
 
 
 

 
 
 
(ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and
 
 
 
 

 
 
 
(iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and
 
 
 
 

 
 
 
(iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
 
 
 
 

 
 
 
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with etanercept are not eligible to commence treatment with etanercept until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
 
 
 
 

 
 
 
the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and, in the case of patients recommencing therapy with etanercept in this Treatment Cycle, evidence of the patient's response to their most recent course of PBS-subsidised etanercept therapy;
 
 
 
 

 
 
 
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Initial treatment, for up to 4 months, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, and who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against the predetermined response criteria does not support continuation of PBS-subsidised treatment; and
 
 
 
 

 
 
 
where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti-rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or leflunomide in combination with methotrexate or cyclosporin alone, unless treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and
 
 
 
 

 
 
 
where the following conditions apply:
 
 
 
 

 
 
 
failure to achieve an adequate response is demonstrated by an elevated erythrocyte sedimentation rate greater than 25 mm per hour or a C-reactive protein level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints or at least 4 active joints from the following list:
 
 
 
 

 
 
 
— elbow, wrist, knee or ankle (assessed as swollen and tender);
 
 
 
 

 
 
 
— shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
if the requirement to demonstrate an elevated erythrocyte sedimentation rate or C-reactive protein level cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
 
 
 
 

 
 
 
the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment;
 
 
 
 

 
 
 
where the patient is exempted from demonstrating an inadequate response to the treatment regimens specified above, the authority application includes details of the contraindication or intolerance, including the degree of toxicity
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Initial treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 4 months, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 4 months of uninterrupted therapy
 
 
 
 

 
Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing treatment with etanercept within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
Injection
2
5
Enbrel

 
 
 
 (a) who have a documented history of severe active rheumatoid arthritis; and
 
 
 
 

 
 
 
 (b) who have demonstrated an adequate response to treatment with etanercept; and
 
 
 
 

 
 
 
 (c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with etanercept; and
 
 
 
 

 
 
 
 where bDMARD means adalimumab, anakinra, etanercept, infliximab or rituximab; and
 
 
 
 

 
 
 
 where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 patients who commenced PBS-subsidised bDMARD treatment prior to 1 August 2007 are deemed to have commenced their first bDMARD treatment cycle with that therapy;
 
 
 
 

 
 
 
 an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
 
 
 
 

 
 
 
 a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
 
 
 
 

 
 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and
 
 
 
 

 
 
 
 (b) if the course of therapy is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;
 
 
 
 

 
 
 
 if the most recent course of etanercept therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
 
 
 
 

 
 
 
 the patient has not failed to demonstrate response to a course of PBS-subsidised etanercept in this Treatment Cycle;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial PBS-subsidised supply for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who were receiving treatment with etanercept prior to 1 December 2002, who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against predetermined response criteria does not support continuation of PBS-subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and where the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing PBS-subsidised treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who, at the time of application, demonstrate an adequate response to treatment with etanercept as manifested by an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and an active joint count of fewer than 10 active (swollen and tender) joints or a reduction in the active (swollen and tender) joint count by at least 50% from baseline or a reduction in the number of the following active joints, from at least 4, by at least 50%:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as swollen and tender);
 
 
 
 

 
 
 
 — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 the authority application includes sufficient information to determine the patient's response to treatment with etanercept according to the above criteria and the date of assessment of the patient;
 
 
 
 

 
 
 
 patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment;
 
 
 
 

 
 
 
 authority applications for re-treatment with etanercept following a break in PBS-subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course
 
 
 
 

 
Injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:
Injection
1
3
Enbrel

 
 
 
 (a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with one of these drugs, has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and
 
 
 
 

 
 
 
 (b) who has at least 2 of the following:
 
 
 
 

 
 
 
 (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or
 
 
 
 

 
 
 
 (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or
 
 
 
 

 
 
 
 (iii) limitation of chest expansion relative to normal values for age and gender; and
 
 
 
 

 
 
 
 (c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and
 
 
 
 

 
 
 
 (d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
 
 
 
 

 
 
 
 where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 failure to achieve an adequate response is demonstrated by:
 
 
 
 

 
 
 
 (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and
 
 
 
 

 
 
 
 (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L;
 
 
 
 

 
 
 
 both ESR and CRP measurements are included in the authority application and are no more than 1 month old;
 
 
 
 

 
 
 
 if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied;
 
 
 
 

 
 
 
 the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;
 
 
 
 

 
 
 
 if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used;
 
 
 
 

 
 
 
 if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication;
 
 
 
 

 
 
 
 if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;
 
 
 
 

 
 
 
 an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;
 
 
 
 

 
 
 
 if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;
 
 
 
 

 
 
 
 the application for authorisation includes:
 
 
 
 

 
 
 
 (a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
 
 
 
 

 
 
 
 (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
 
 
 
 

 
 
 
 (ii) a completed BASDAI Assessment Form; and
 
 
 
 

 
 
 
 (iii) a signed patient acknowledgment form; and
 
 
 
 

 
 
 
 (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;
 
 
 
 

 
 
 
 a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS-subsidised therapy with etanercept; and
 
 
 
 

 
 
 
 where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 a patient who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment;
 
 
 
 

 
 
 
 the application is accompanied by the results of the patient's most recent course of PBS-subsidised adalimumab, etanercept or infliximab therapy, where:
 
 
 
 

 
 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and
 
 
 
 

 
 
 
 (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or
 
 
 
 

 
 
 
 (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;
 
 
 
 

 
 
 
 if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;
 
 
 
 

 
 
 
 a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
Injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with etanercept, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with etanercept; and
Injection
1
5
Enbrel

 
 
 
 where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 a patient who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;
 
 
 
 

 
 
 
 response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:
 
 
 
 

 
 
 
 (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or
 
 
 
 

 
 
 
 (b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or
 
 
 
 

 
 
 
 (c) an ESR or CRP measurement reduced by at least 20% from baseline;
 
 
 
 

 
 
 
 if the patient commenced treatment with etanercept prior to 1 July 2004, was commenced on PBS-subsidised treatment prior to 1 March 2007 and is continuing to receive PBS-subsidised treatment in their first treatment cycle, and where pre-treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, or no greater than 2, and 1 of the following:
 
 
 
 

 
 
 
 (a) an ESR measurement no greater than 25 mm per hour; or
 
 
 
 

 
 
 
 (b) a CRP measurement no greater than 10 mg per L;
 
 
 
 

 
 
 
 all measurements provided are no more than 1 month old at the time of application;
 
 
 
 

 
 
 
 the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient;
 
 
 
 

 
 
 
 patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
 
 
 
 

 
 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and
 
 
 
 

 
 
 
 (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or
 
 
 
 

 
 
 
 (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;
 
 
 
 

 
 
 
 the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

 
Injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
 (1) have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and
Injection
1
3
Enbrel

 
 
 
 
 
 
 

 
 
 
 (2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and
 
 
 
 

 
 
 
 (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to achieve an adequate response to treatment with either methotrexate or sulfasalazine, at an adequate dose, for a minimum of 3 months; and
 
 
 
 

 
 
 
 (4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and
 
 
 
 

 
 
 
 (5) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
 
 
 
 

 
 
 
 if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
 
 
 
 

 
 
 
 if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form;
 
 
 
 

 
 
 
 a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment, or recommencement of treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
 
 
 
 

 
 
 
 (1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and
 
 
 
 

 
 
 
 (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and
 
 
 
 

 
 
 
 (3) have not failed treatment with etanercept during the current Treatment Cycle; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle;
 
 
 
 

 
 
 
 patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if:
 
 
 
 

 
 
 
 (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with etanercept, to their most recent course of PBS-subsidised etanercept treatment; and
 
 
 
 

 
 
 
 (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and
 
 
 
 

 
 
 
 (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and
 
 
 
 

 
 
 
 (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form;
 
 
 
 

 
 
 
 a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
Injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of etanercept for continuing treatment, by a rheumatologist or by an immunologist with expertise in the management of psoriatic arthritis, of adults who:
Injection
1
5
Enbrel

 
 
 
 (1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and
 
 
 
 

 
 
 
 (2) were receiving treatment with etanercept prior to 17 March 2005; and
 
 
 
 

 
 
 
 (3) have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and
 
 
 
 

 
 
 
 (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgement form;
 
 
 
 

 
 
 
 the course of treatment is limited to a maximum of 24 weeks of treatment;
 
 
 
 

 
 
 
 patients are eligible for PBS-subsidised treatment under the above criteria once only
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing treatment within an ongoing Biological Treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults:
 
 
 
 

 
 
 
 (1) who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status; and
 
 
 
 

 
 
 
 (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with etanercept; and
 
 
 
 

 
 
 
 (3) who, at the time of application, demonstrate an adequate response to treatment with etanercept; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 an adequate response to treatment with etanercept is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;
 
 
 
 

 
 
 
 if the most recent course of etanercept therapy was a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

 
Injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Initial treatment commencing a biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
Injection
1
3
Enbrel

 
 
 
 (a) have severe active rheumatoid arthritis; and
 
 
 
 

 
 
 
 (b) have not previously received PBS-subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS-subsidised treatment with a bDMARD for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised bDMARD treatment for this condition was approved; and
 
 
 
 

 
 
 
 (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and
 
 
 
 

 
 
 
 where bDMARD means adalimumab, anakinra, etanercept, infliximab or rituximab; and
 
 
 
 

 
 
 
 where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 failure to achieve an adequate response to the treatment regimens specified at (c) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
 
 
 
 

 
 
 
 if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
 
 
 
 

 
 
 
 if intolerance to treatment with the regimens specified at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a signed patient acknowledgment;
 
 
 
 

 
 
 
 a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment in a bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment, or recommencement of treatment, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
 
 
 
 

 
 
 
 (a) have a documented history of severe active rheumatoid arthritis; and
 
 
 
 

 
 
 
 (b) have received prior PBS-subsidised treatment with a bDMARD for this condition in this Treatment Cycle and who are eligible to receive further bDMARD therapy within this Treatment Cycle; and
 
 
 
 

 
 
 
 (c) have not failed previous PBS-subsidised treatment with etanercept during this Treatment Cycle; and
 
 
 
 

 
 
 
 where bDMARD means adalimumab, anakinra, etanercept, infliximab or rituximab; and
 
 
 
 

 
 
 
 where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 patients who commenced PBS-subsidised bDMARD treatment prior to 1 August 2007 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy;
 
 
 
 

 
 
 
 patients are eligible to receive further therapy with bDMARD within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this Treatment Cycle;
 
 
 
 

 
 
 
 patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this bDMARD Treatment Cycle are eligible to recommence therapy with this drug within this same cycle provided that:
 
 
 
 

 
 
 
 (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment of rheumatoid arthritis, to their most recent course of PBS-subsidised etanercept treatment; and
 
 
 
 

 
 
 
 (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and
 
 
 
 

 
 
 
 (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and
 
 
 
 

 
 
 
 (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
 
 
 
 

 
 
 
 patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with etanercept are not eligible to commence treatment with etanercept until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and, in the case of patients recommencing therapy with etanercept in this Treatment Cycle, evidence of the patient's response to their most recent course of PBS-subsidised etanercept therapy;
 
 
 
 

 
 
 
 a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment, for up to 4 months, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, and who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against the predetermined response criteria does not support continuation of PBS-subsidised treatment; and
 
 
 
 

 
 
 
 where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti-rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or leflunomide in combination with methotrexate or cyclosporin alone, unless treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 failure to achieve an adequate response is demonstrated by an elevated erythrocyte sedimentation rate greater than 25 mm per hour or a C-reactive protein level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints or at least 4 active joints from the following list:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as swollen and tender);
 
 
 
 

 
 
 
 — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 if the requirement to demonstrate an elevated erythrocyte sedimentation rate or C-reactive protein level cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
 
 
 
 

 
 
 
 the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment;
 
 
 
 

 
 
 
 where the patient is exempted from demonstrating an inadequate response to the treatment regimens specified above, the authority application includes details of the contraindication or intolerance, including the degree of toxicity
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Initial treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 4 months, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 4 months of uninterrupted therapy
 
 
 
 

 
Injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing treatment with etanercept within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
Injection
1
5
Enbrel

 
 
 
 (a) who have a documented history of severe active rheumatoid arthritis; and
 
 
 
 

 
 
 
 (b) who have demonstrated an adequate response to treatment with etanercept; and
 
 
 
 

 
 
 
 (c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with etanercept; and
 
 
 
 

 
 
 
 where bDMARD means adalimumab, anakinra, etanercept, infliximab or rituximab; and
 
 
 
 

 
 
 
 where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 patients who commenced PBS-subsidised bDMARD treatment prior to 1 August 2007 are deemed to have commenced their first bDMARD treatment cycle with that therapy;
 
 
 
 

 
 
 
 an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
 
 
 
 

 
 
 
 a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
 
 
 
 

 
 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and
 
 
 
 

 
 
 
 (b) if the course of therapy is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;
 
 
 
 

 
 
 
 if the most recent course of etanercept therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
 
 
 
 

 
 
 
 the patient has not failed to demonstrate response to a course of PBS-subsidised etanercept in this Treatment Cycle;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial PBS-subsidised supply for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who were receiving treatment with etanercept prior to 1 December 2002, who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against predetermined response criteria does not support continuation of PBS-subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and where the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing PBS-subsidised treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who, at the time of application, demonstrate an adequate response to treatment with etanercept as manifested by an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and an active joint count of fewer than 10 active (swollen and tender) joints or a reduction in the active (swollen and tender) joint count by at least 50% from baseline or a reduction in the number of the following active joints, from at least 4, by at least 50%:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as swollen and tender);
 
 
 
 

 
 
 
 — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 the authority application includes sufficient information to determine the patient's response to treatment with etanercept according to the above criteria and the date of assessment of the patient;
 
 
 
 

 
 
 
 patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment;
 
 
 
 

 
 
 
 authority applications for re-treatment with etanercept following a break in PBS-subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course
 
 
 
 

 
Injections 50 mg in 1 mL single use pre-filled syringes, 4
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:
Injection
1
3
Enbrel

 
 
 
 (a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with one of these drugs, has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and
 
 
 
 

 
 
 
 (b) who has at least 2 of the following:
 
 
 
 

 
 
 
 (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or
 
 
 
 

 
 
 
 (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or
 
 
 
 

 
 
 
 (iii) limitation of chest expansion relative to normal values for age and gender; and
 
 
 
 

 
 
 
 (c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and
 
 
 
 

 
 
 
 (d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
 
 
 
 

 
 
 
 where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 failure to achieve an adequate response is demonstrated by:
 
 
 
 

 
 
 
 (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and
 
 
 
 

 
 
 
 (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L;
 
 
 
 

 
 
 
 both ESR and CRP measurements are included in the authority application and are no more than 1 month old;
 
 
 
 

 
 
 
 if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied;
 
 
 
 

 
 
 
 the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;
 
 
 
 

 
 
 
 if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used;
 
 
 
 

 
 
 
 if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication;
 
 
 
 

 
 
 
 if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;
 
 
 
 

 
 
 
 an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;
 
 
 
 

 
 
 
 if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;
 
 
 
 

 
 
 
 the application for authorisation includes:
 
 
 
 

 
 
 
 (a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
 
 
 
 

 
 
 
 (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
 
 
 
 

 
 
 
 (ii) a completed BASDAI Assessment Form; and
 
 
 
 

 
 
 
 (iii) a signed patient acknowledgment form; and
 
 
 
 

 
 
 
 (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;
 
 
 
 

 
 
 
 a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS-subsidised therapy with etanercept; and
 
 
 
 

 
 
 
 where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 a patient who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment;
 
 
 
 

 
 
 
 the application is accompanied by the results of the patient's most recent course of PBS-subsidised adalimumab, etanercept or infliximab therapy, where:
 
 
 
 

 
 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and
 
 
 
 

 
 
 
 (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or
 
 
 
 

 
 
 
 (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;
 
 
 
 

 
 
 
 if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment;
 
 
 
 

 
 
 
 a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
Injections 50 mg in 1 mL single use pre-filled syringes, 4
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with etanercept, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with etanercept; and
Injection
1
5
Enbrel

 
 
 
 where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 a patient who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy;
 
 
 
 

 
 
 
 response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:
 
 
 
 

 
 
 
 (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or
 
 
 
 

 
 
 
 (b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or
 
 
 
 

 
 
 
 (c) an ESR or CRP measurement reduced by at least 20% from baseline;
 
 
 
 

 
 
 
 if the patient commenced treatment with etanercept prior to 1 July 2004, was commenced on PBS-subsidised treatment prior to 1 March 2007 and is continuing to receive PBS-subsidised treatment in their first treatment cycle, and where pre-treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, or no greater than 2, and 1 of the following:
 
 
 
 

 
 
 
 (a) an ESR measurement no greater than 25 mm per hour; or
 
 
 
 

 
 
 
 (b) a CRP measurement no greater than 10 mg per L;
 
 
 
 

 
 
 
 all measurements provided are no more than 1 month old at the time of application;
 
 
 
 

 
 
 
 the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient;
 
 
 
 

 
 
 
 patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
 
 
 
 

 
 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and
 
 
 
 

 
 
 
 (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or
 
 
 
 

 
 
 
 (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment;
 
 
 
 

 
 
 
 the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

 
Injections 50 mg in 1 mL single use pre-filled syringes, 4
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
Injection
1
3
Enbrel

 
 
 
 (1) have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and
 
 
 
 

 
 
 
 (2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and
 
 
 
 

 
 
 
 (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to achieve an adequate response to treatment with either methotrexate or sulfasalazine, at an adequate dose, for a minimum of 3 months; and
 
 
 
 

 
 
 
 (4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and
 
 
 
 

 
 
 
 (5) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
 
 
 
 

 
 
 
 if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
 
 
 
 

 
 
 
 if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form;
 
 
 
 

 
 
 
 a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment, or recommencement of treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
 
 
 
 

 
 
 
 (1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and
 
 
 
 

 
 
 
 (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and
 
 
 
 

 
 
 
 (3) have not failed treatment with etanercept during the current Treatment Cycle; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle;
 
 
 
 

 
 
 
 patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if:
 
 
 
 

 
 
 
 (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with etanercept, to their most recent course of PBS-subsidised etanercept treatment; and
 
 
 
 

 
 
 
 (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and
 
 
 
 

 
 
 
 (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and
 
 
 
 

 
 
 
 (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form;
 
 
 
 

 
 
 
 a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
Injections 50 mg in 1 mL single use pre-filled syringes, 4
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of etanercept for continuing treatment, by a rheumatologist or by an immunologist with expertise in the management of psoriatic arthritis, of adults who:
Injection
1
5
Enbrel

 
 
 
 (1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and
 
 
 
 

 
 
 
 (2) were receiving treatment with etanercept prior to 17 March 2005; and
 
 
 
 

 
 
 
 (3) have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and
 
 
 
 

 
 
 
 (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgement form;
 
 
 
 

 
 
 
 the course of treatment is limited to a maximum of 24 weeks of treatment;
 
 
 
 

 
 
 
 patients are eligible for PBS-subsidised treatment under the above criteria once only
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing treatment within an ongoing Biological Treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults:
 
 
 
 

 
 
 
 (1) who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status; and
 
 
 
 

 
 
 
 (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with etanercept; and
 
 
 
 

 
 
 
 (3) who, at the time of application, demonstrate an adequate response to treatment with etanercept; and
 
 
 
 

 
 
 
 where biological agent means adalimumab or etanercept or infliximab; and
 
 
 
 

 
 
 
 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 an adequate response to treatment with etanercept is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;
 
 
 
 

 
 
 
 if the most recent course of etanercept therapy was a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

 
Injections 50 mg in 1 mL single use pre-filled syringes, 4
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Initial treatment commencing a biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
Injection
1
3
Enbrel

 
 
 
 (a) have severe active rheumatoid arthritis; and
 
 
 
 

 
 
 
 (b) have not previously received PBS-subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS-subsidised treatment with a bDMARD for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised bDMARD treatment for this condition was approved; and
 
 
 
 

 
 
 
 (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and
 
 
 
 

 
 
 
 where bDMARD means adalimumab, anakinra, etanercept, infliximab or rituximab; and
 
 
 
 

 
 
 
 where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 failure to achieve an adequate response to the treatment regimens specified at (c) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
 
 
 
 

 
 
 
 if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
 
 
 
 

 
 
 
 if intolerance to treatment with the regimens specified at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a signed patient acknowledgment;
 
 
 
 

 
 
 
 a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment in a bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment, or recommencement of treatment, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
 
 
 
 

 
 
 
 (a) have a documented history of severe active rheumatoid arthritis; and
 
 
 
 

 
 
 
 (b) have received prior PBS-subsidised treatment with a bDMARD for this condition in this Treatment Cycle and who are eligible to receive further bDMARD therapy within this Treatment Cycle; and
 
 
 
 

 
 
 
 (c) have not failed previous PBS-subsidised treatment with etanercept during this Treatment Cycle; and
 
 
 
 

 
 
 
 where bDMARD means adalimumab, anakinra, etanercept, infliximab or rituximab; and
 
 
 
 

 
 
 
 where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 patients who commenced PBS-subsidised bDMARD treatment prior to 1 August 2007 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy;
 
 
 
 

 
 
 
 patients are eligible to receive further therapy with bDMARD within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this Treatment Cycle;
 
 
 
 

 
 
 
 patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this bDMARD Treatment Cycle are eligible to recommence therapy with this drug within this same cycle provided that:
 
 
 
 

 
 
 
 (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment of rheumatoid arthritis, to their most recent course of PBS-subsidised etanercept treatment; and
 
 
 
 

 
 
 
 (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and
 
 
 
 

 
 
 
 (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and
 
 
 
 

 
 
 
 (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
 
 
 
 

 
 
 
 patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with etanercept are not eligible to commence treatment with etanercept until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and, in the case of patients recommencing therapy with etanercept in this Treatment Cycle, evidence of the patient's response to their most recent course of PBS-subsidised etanercept therapy;
 
 
 
 

 
 
 
 a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial treatment, for up to 4 months, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, and who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against the predetermined response criteria does not support continuation of PBS-subsidised treatment; and
 
 
 
 

 
 
 
 where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti-rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or leflunomide in combination with methotrexate or cyclosporin alone, unless treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 failure to achieve an adequate response is demonstrated by an elevated erythrocyte sedimentation rate greater than 25 mm per hour or a C-reactive protein level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints or at least 4 active joints from the following list:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as swollen and tender);
 
 
 
 

 
 
 
 — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 if the requirement to demonstrate an elevated erythrocyte sedimentation rate or C-reactive protein level cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
 
 
 
 

 
 
 
 the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment;
 
 
 
 

 
 
 
 where the patient is exempted from demonstrating an inadequate response to the treatment regimens specified above, the authority application includes details of the contraindication or intolerance, including the degree of toxicity
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Initial treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 4 months, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 4 months of uninterrupted therapy
 
 
 
 

 
Injections 50 mg in 1 mL single use pre-filled syringes, 4
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing treatment with etanercept within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
Injection
1
5
Enbrel

 
 
 
 (a) who have a documented history of severe active rheumatoid arthritis; and
 
 
 
 

 
 
 
 (b) who have demonstrated an adequate response to treatment with etanercept; and
 
 
 
 

 
 
 
 (c) whose most recent course of PBS-subsidised bDMARD treatment in this bDMARD Treatment Cycle was with etanercept; and
 
 
 
 

 
 
 
 where bDMARD means adalimumab, anakinra, etanercept, infliximab or rituximab; and
 
 
 
 

 
 
 
 where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 patients who commenced PBS-subsidised bDMARD treatment prior to 1 August 2007 are deemed to have commenced their first bDMARD treatment cycle with that therapy;
 
 
 
 

 
 
 
 an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or
 
 
 
 

 
 
 
 — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
 
 
 
 

 
 
 
 the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response;
 
 
 
 

 
 
 
 a patient will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless:
 
 
 
 

 
 
 
 (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and
 
 
 
 

 
 
 
 (b) if the course of therapy is a 16-week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course;
 
 
 
 

 
 
 
 if the most recent course of etanercept therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
 
 
 
 

 
 
 
 the patient has not failed to demonstrate response to a course of PBS-subsidised etanercept in this Treatment Cycle;
 
 
 
 

 
 
 
 a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
 In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Initial PBS-subsidised supply for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who were receiving treatment with etanercept prior to 1 December 2002, who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against predetermined response criteria does not support continuation of PBS-subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and where the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing PBS-subsidised treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who, at the time of application, demonstrate an adequate response to treatment with etanercept as manifested by an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and an active joint count of fewer than 10 active (swollen and tender) joints or a reduction in the active (swollen and tender) joint count by at least 50% from baseline or a reduction in the number of the following active joints, from at least 4, by at least 50%:
 
 
 
 

 
 
 
 — elbow, wrist, knee or ankle (assessed as swollen and tender);
 
 
 
 

 
 
 
 — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and
 
 
 
 

 
 
 
 where the following conditions apply:
 
 
 
 

 
 
 
 the authority application includes sufficient information to determine the patient's response to treatment with etanercept according to the above criteria and the date of assessment of the patient;
 
 
 
 

 
 
 
 patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment;
 
 
 
 

 
 
 
 authority applications for re-treatment with etanercept following a break in PBS-subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course
 
 
 
 

Famciclovir
Tablet 250 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis
Oral
56
5
Famvir

 
Tablet 500 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes in immunocompromised patients, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis
Oral
56
5
Famvir

 
 
 
Episodic treatment of moderate to severe recurrent oral or labial herpes in a patient with human immunodeficiency virus infection and a CD4 cell count of less than 500 million per L, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis
 
 
 
 

 
 
 
Suppressive therapy of moderate to severe recurrent oral or labial herpes in a patient with human immunodeficiency virus infection and a CD4 cell count of less than 150 million per L, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis
 
 
 
 

 
 
 
Suppressive therapy of moderate to severe recurrent oral or labial herpes in a patient with human immunodeficiency virus infection and other opportunistic infections or Acquired Immunodeficiency Syndrome defining tumours, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis
 
 
 
 

Fentanyl
Transdermal patch 2.1 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Transdermal
10
..
Durogesic 12

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Transdermal patch 4.2 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Transdermal
10
..
Durogesic 25

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Transdermal patch 8.4 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Transdermal
10
..
Durogesic 50

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Transdermal patch 12.6 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Transdermal
10
..
Durogesic 75

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Transdermal patch 16.8 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Transdermal
10
..
Durogesic 100

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

Granisetron
Tablet 2 mg (as hydrochloride)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Management of nausea and vomiting associated with radiotherapy being used to treat malignancy
Oral
5
1
Kytril

 
Concentrated injection 3 mg (as hydrochloride) in 3 mL
 
In compliance with authority procedures set out in subparagraph 11 (d):
Management of nausea and vomiting associated with radiotherapy being used to treat malignancy
Injection
1
..
Kytril

Hydrocortisone
Injection 100 mg (as sodium succinate) with 2 mL solvent
 
For use in a hospital
Injection
6
..
Solu-Cortef

 
Injection 250 mg (as sodium succinate) with 2 mL solvent
 
For use in a hospital
Injection
6
..
Solu-Cortef

Hydromorphone
Tablet containing hydromorphone hydrochloride 2 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
40
..
Dilaudid

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Tablet containing hydromorphone hydrochloride 4 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
40
..
Dilaudid

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Tablet containing hydromorphone hydrochloride 8 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
40
..
Dilaudid

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 473 mL
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
2
..
Dilaudid

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

Ibuprofen
Tablet 400 mg
 
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
Oral
90
3
Brufen

Interferon Alfa-2a
Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe
 
In compliance with authority procedures set out in subparagraph 11 (d):
Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy
Injection
15
5
Roferon-A

 
Injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe
 
In compliance with authority procedures set out in subparagraph 11 (d):
Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy
Injection
5
5
Roferon-A

 
Injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe
 
In compliance with authority procedures set out in subparagraph 11 (d):
Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy
Injection
5
5
Roferon-A

 
Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe
 
In compliance with authority procedures set out in subparagraph 11 (d):
Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy
Injection
5
5
Roferon-A

Interferon Alfa-2b
Solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen
 
In compliance with authority procedures set out in subparagraph 11 (d):
Maintenance treatment of multiple myeloma once remission has been achieved with chemotherapy
Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy
Injection
3
5
Intron A Redipen

"Karicare De-Lact"
Oral powder 900 g
 
In compliance with authority procedures set out in subparagraph 11 (d):
Proven chronic lactose intolerance in patients up to the age of 12 months, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet
Oral
5
5
Karicare De-Lact

Ketoconazole
Tablet 200 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Oral candidiasis in severely immunocompromised persons where topical therapy has failed
Systemic or deep mycoses where other forms of therapy have failed
Oral
30
5
Nizoral

Lansoprazole
Capsule 30 mg
 
Gastro-oesophageal reflux disease
Scleroderma oesophagus
Oral
30
5
Zoton

 
Sachet containing granules for oral suspension, 30 mg per sachet
 
Gastro-oesophageal reflux disease
Scleroderma oesophagus
Oral
28
5
Zoton

 
Sachet containing granules for oral suspension, 30 mg per sachet
 
In compliance with authority procedures set out in subparagraph 11 (d):
Initial treatment of peptic ulcer, in patients unable to take a solid dose form of a proton pump inhibitor
Oral
28
1
Zoton

 
Sachet containing granules for oral suspension, 30 mg per sachet
 
In compliance with authority procedures set out in subparagraph 11 (d):
Gastro-oesophageal reflux disease, in patients unable to take a solid dose form of a proton pump inhibitor
Scleroderma oesophagus, in patients unable to take a solid dose form of a proton pump inhibitor
Oral
28
5
Zoton

Lercanidipine
Tablet containing lercanidipine hydrochloride 10 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Adverse effects occurring with all of the base-priced drugs
Oral
30
5
Zanidip

 
 
 
Drug interactions occurring with all of the base-priced drugs
 
 
 
 

 
 
 
Drug interactions expected to occur with all of the base-priced drugs
 
 
 
 

 
 
 
Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance
 
 
 
 

 
Tablet containing lercanidipine hydrochloride 20 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Adverse effects occurring with all of the base-priced drugs
Oral
30
5
Zanidip

 
 
 
Drug interactions occurring with all of the base-priced drugs
 
 
 
 

 
 
 
Drug interactions expected to occur with all of the base-priced drugs
 
 
 
 

 
 
 
Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance
 
 
 
 

Levetiracetam
Tablet 250 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
Oral
60
5
Keppra

 
 
 
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
 
 
 
 

 
 
 
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
 
 
 
 

 
Tablet 500 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
Oral
60
5
Keppra

 
 
 
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
 
 
 
 

 
 
 
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
 
 
 
 

 
Tablet 1 g
 
In compliance with authority procedures set out in subparagraph 11 (d):
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
Oral
60
5
Keppra

 
 
 
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
 
 
 
 

 
 
 
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
 
 
 
 

Medroxyprogesterone
Tablet containing medroxyprogesterone acetate 10 mg
 
Endometriosis
Oral
100
2
Provera
Ralovera

Methadone
Tablet containing methadone hydrochloride 10 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
40
..
Physeptone

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Injection containing methadone hydrochloride 10 mg in 1 mL
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Injection
10
..
Physeptone

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

Metronidazole
Tablet 400 mg
 
Treatment of anaerobic infections
Oral
21
1
Flagyl
Metrogyl 400
Metronide 400

Morphine
Tablet containing morphine sulfate 30 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
40
..
Anamorph

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Tablet containing morphine sulfate 5 mg (controlled release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Oral
40
..
MS Contin

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Tablet containing morphine sulfate 10 mg (controlled release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Oral
40
..
MS Contin

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Tablet containing morphine sulfate 15 mg (controlled release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Oral
40
..
MS Contin

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Tablet containing morphine sulfate 30 mg (controlled release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Oral
40
..
MS Contin

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Tablet containing morphine sulfate 60 mg (controlled release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Oral
40
..
MS Contin

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Tablet containing morphine sulfate 100 mg (controlled release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Oral
40
..
MS Contin

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Capsule containing morphine sulfate 10 mg (containing sustained release pellets)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Oral
40
..
Kapanol

 
 
 
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Capsule containing morphine sulfate 20 mg (containing sustained release pellets)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Oral
40
..
Kapanol

 
 
 
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Capsule containing morphine sulfate 30 mg (controlled release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Oral
20
..
MS Mono

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Capsule containing morphine sulfate 50 mg (containing sustained release pellets)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Oral
40
..
Kapanol

 
 
 
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Capsule containing morphine sulfate 60 mg (controlled release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Oral
20
..
MS Mono

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Capsule containing morphine sulfate 90 mg (controlled release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Oral
20
..
MS Mono

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Capsule containing morphine sulfate 100 mg (containing sustained release pellets)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Oral
40
..
Kapanol

 
 
 
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Capsule containing morphine sulfate 120 mg (controlled release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Oral
20
..
MS Mono

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Sachet containing controlled release granules for oral suspension, containing morphine sulfate 20 mg per sachet
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Oral
40
..
MS Contin Suspension 20 mg

 
 
 
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Sachet containing controlled release granules for oral suspension, containing morphine sulfate 30 mg per sachet
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Oral
40
..
MS Contin Suspension 30 mg

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Sachet containing controlled release granules for oral suspension, containing morphine sulfate 60 mg per sachet
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Oral
40
..
MS Contin Suspension 60 mg

 
 
 
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Sachet containing controlled release granules for oral suspension, containing morphine sulfate 100 mg per sachet
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Oral
40
..
MS Contin Suspension 100 mg

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Oral solution containing morphine hydrochloride 2 mg per mL, 200 mL
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
2
..
Ordine 2

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Oral solution containing morphine hydrochloride 5 mg per mL, 200 mL
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
2
..
Ordine 5

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Oral solution containing morphine hydrochloride 10 mg per mL, 200 mL
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
2
..
Ordine 10

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

Naratriptan
Tablet 2.5 mg (as hydrochloride)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where adverse events have occurred with other suitable PBS-listed drugs
Oral
4
5
Naramig

 
 
 
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where drug interactions have occurred with other suitable PBS-listed drugs
 
 
 
 

 
 
 
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where drug interactions are expected to occur with other suitable PBS-listed drugs
 
 
 
 

 
 
 
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where transfer to another suitable PBS-listed drug would cause patient confusion resulting in problems with compliance
 
 
 
 

 
 
 
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where transfer to another suitable PBS-listed drug is likely to result in adverse clinical consequences
 
 
 
 

"Neocate"
Oral powder 400 g
 
In compliance with authority procedures set out in subparagraph 11 (d):
Continuing treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
Oral
8
5
Neocate

 
 
 
Treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged 2 years or over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
 
 
 
 

 
 
 
Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed
 
 
 
 

 
 
 
Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition
 
 
 
 

"Neocate Advance"
Oral powder 400 g
 
In compliance with authority procedures set out in subparagraph 11 (d):
Continuing treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
Oral
8
5
Neocate Advance

 
 
 
Treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged 2 years or over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
 
 
 
 

 
 
 
Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed
 
 
 
 

 
 
 
Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition
 
 
 
 

"Neocate Advance Tropical Flavour"
Oral powder 400 g
 
In compliance with authority procedures set out in subparagraph 11 (d):
Continuing treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
Oral
8
5
Neocate Advance Tropical Flavour

 
 
 
Treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged 2 years or over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
 
 
 
 

 
 
 
Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed
 
 
 
 

 
 
 
Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition
 
 
 
 

"Neocate LCP"
Oral powder 400 g
 
In compliance with authority procedures set out in subparagraph 11 (d):
Continuing treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged less than 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
Oral
8
5
Neocate LCP

 
 
 
Treatment for combined intolerance (not infant colic) to cows' milk protein and protein hydrolysate formulae in a child aged 2 years or over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
 
 
 
 

 
 
 
Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed
 
 
 
 

 
 
 
Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition
 
 
 
 

Nifedipine
Tablet 20 mg (controlled release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Adverse effects occurring with all of the base-priced drugs
Oral
30
5
Adalat Oros 20mg

 
 
 
Drug interactions occurring with all of the base-priced drugs
 
 
 
 

 
 
 
Drug interactions expected to occur with all of the base-priced drugs
 
 
 
 

 
 
 
Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance
 
 
 
 

Nitrazepam
Tablet 5 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Myoclonic epilepsy
Oral
50
5
Alodorm
Mogadon

 
 
 
Malignant neoplasia (late stage)
 
 
 
 

 
 
 
For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
 
 
 
 

 
 
 
For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
 
 
 
 

Omeprazole
Tablet 20 mg
 
Gastro-oesophageal reflux disease
Scleroderma oesophagus
Zollinger-Ellison syndrome
Oral
30
5
Meprazol
Omeprazole Winthrop

 
Tablet 20 mg (as magnesium)
 
Gastro-oesophageal reflux disease
Scleroderma oesophagus
Zollinger-Ellison syndrome
Oral
30
5
Acimax Tablets
Losec Tablets
Omepral

 
Capsule 20 mg
 
Gastro-oesophageal reflux disease
Scleroderma oesophagus
Zollinger-Ellison syndrome
Oral
30
5
Probitor

Ondansetron
Tablet 4 mg (as hydrochloride dihydrate)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Management of nausea and vomiting associated with radiotherapy being used to treat malignancy
Oral
10
1
Ondansetron-RL
Ondaz
Onsetron 4
Zofran

 
Tablet 8 mg (as hydrochloride dihydrate)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Management of nausea and vomiting associated with radiotherapy being used to treat malignancy
Oral
10
1
Ondansetron-RL
Ondaz
Onsetron 8
Zofran

 
Wafer 4 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Management of nausea and vomiting associated with radiotherapy being used to treat malignancy
Oral
10
1
Ondansetron-RL Zydis
Ondaz Zydis
Zofran Zydis

 
Wafer 8 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Management of nausea and vomiting associated with radiotherapy being used to treat malignancy
Oral
10
1
Ondansetron-RL Zydis
Ondaz Zydis
Zofran Zydis

 
I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL
 
In compliance with authority procedures set out in subparagraph 11 (d):
Management of nausea and vomiting associated with radiotherapy being used to treat malignancy
Injection
1
..
Ondansetron-RL
Ondaz
Pfizer Pty Limited
Zofran

 
I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL
 
In compliance with authority procedures set out in subparagraph 11 (d):
Management of nausea and vomiting associated with radiotherapy being used to treat malignancy
Injection
1
..
Ondansetron-RL
Ondaz
Pfizer Pty Limited
Zofran

Oxazepam
Tablet 15 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Malignant neoplasia (late stage)
Oral
50
5
Alepam 15
Serepax

 
 
 
For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
 
 
 
 

 
 
 
For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
 
 
 
 

 
Tablet 30 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Malignant neoplasia (late stage)
Oral
50
5
Alepam 30
Murelax
Serepax

 
 
 
For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
 
 
 
 

 
 
 
For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
 
 
 
 

Oxycodone
Tablet containing oxycodone hydrochloride 5 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
40
..
Endone

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Capsule containing oxycodone hydrochloride 5 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
40
..
OxyNorm

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Capsule containing oxycodone hydrochloride 10 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
40
..
OxyNorm

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Capsule containing oxycodone hydrochloride 20 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
40
..
OxyNorm

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Oral solution containing oxycodone hydrochloride 5 mg per 5 mL, 250 mL
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Oral
2
..
OxyNorm Liquid 5mg/5mL

 
 
 
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Tablet containing oxycodone hydrochloride 5 mg (controlled release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Oral
40
..
OxyContin

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Tablet containing oxycodone hydrochloride 10 mg (controlled release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Oral
40
..
OxyContin

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Tablet containing oxycodone hydrochloride 20 mg (controlled release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Oral
40
..
OxyContin

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Tablet containing oxycodone hydrochloride 40 mg (controlled release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Oral
40
..
OxyContin

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Tablet containing oxycodone hydrochloride 80 mg (controlled release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Oral
40
..
OxyContin

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

 
Suppository 30 mg (as pectinate)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Rectal
24
..
Proladone

 
 
 
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
 
 
 
 

 
 
 
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
 
 
 
 

 
 
 
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
 
 
 
 

Pantoprazole
Tablet (enteric coated) 40 mg (as sodium sesquihydrate)
 
Gastro-oesophageal reflux disease
Scleroderma oesophagus
Zollinger-Ellison syndrome
Oral
30
5
Somac

Paracetamol
Tablet 500 mg
 
Chronic arthropathies
Oral
300
4
Chem mart Chemadol

 
 
 
 
 
 
 
Dymadon P

 
 
 
 
 
 
 
Febridol

 
 
 
 
 
 
 
Panamax

 
 
 
 
 
 
 
Parahexal

 
 
 
 
 
 
 
Paralgin

 
 
 
 
 
 
 
Parmol

 
 
 
 
 
 
 
Terry White Chemists Paracetamol

 
 
 
 
 
 
 
Tylenol

Pemetrexed
Powder for I.V. infusion 500 mg (as disodium heptahydrate)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where treatment with paclitaxel or docetaxel is contraindicated
Injection
2
2
Alimta

 
 
 
Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where intolerance to treatment with either docetaxel or paclitaxel has developed
 
 
 
 

 
 
 
Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where treatment with either docetaxel or paclitaxel has been unsuccessful
 
 
 
 

 
 
 
Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where transfer to docetaxel or paclitaxel is likely to result in adverse clinical consequences
 
 
 
 

Phenoxymethylpenicillin
Tablet 250 mg phenoxymethyl-penicillin (as potassium)
 
Prophylaxis of recurrent streptococcal infections (including rheumatic fever)
Oral
50
5
Abbocillin-VK Filmtab

 
Capsule 250 mg phenoxymethyl-penicillin (as potassium)
 
Prophylaxis of recurrent streptococcal infections (including rheumatic fever)
Oral
50
5
Cilicaine VK
Cilopen VK
LPV
Penhexal VK

Rabeprazole
Tablet containing rabeprazole sodium 20 mg (enteric coated)
 
Gastro-oesophageal reflux disease
Scleroderma oesophagus
Oral
30
5
Pariet

Ranibizumab
Solution for intravitreal injection 3 mg in 0.3 mL
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
 Continuing treatment by an ophthalmologist, as the sole PBS-subsidised therapy, of subfoveal choroidal neovascularisation due to age-related macular degeneration, where the patient has previously been granted an authority prescription for ranibizumab for treatment of the same eye
Injection
1
1
Lucentis

Ranitidine
Tablet, effervescent, 150 mg (as hydrochloride)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Adverse effects occurring with all of the base-priced drugs
Oral
60
5
Zantac

 
 
 
Drug interactions occurring with all of the base-priced drugs
 
 
 
 

 
 
 
Drug interactions expected to occur with all of the base-priced drugs
 
 
 
 

 
 
 
Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance
 
 
 
 

 
Syrup 150 mg (as hydrochloride) per 10 mL, 300 mL
 
In compliance with authority procedures set out in subparagraph 11 (d):
Adverse effects occurring with all of the base-priced drugs
Oral
2
5
Zantac Syrup

 
 
 
Drug interactions occurring with all of the base-priced drugs
 
 
 
 

 
 
 
Drug interactions expected to occur with all of the base-priced drugs
 
 
 
 

 
 
 
Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance
 
 
 
 

Rifampicin
Capsule 150 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Leprosy in adults
Oral
100
..
Rimycin 150

 
Capsule 300 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Leprosy in adults
Oral
100
..
Rimycin 300

Risperidone
Tablet 0.5 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Oral
60
5
Risperdal

 
 
1589
 Schizophrenia
 
 
 
 

 
Tablet 0.5 mg (orally disintegrating)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Oral
56
5
Risperdal Quicklet

 
 
1589
 Schizophrenia
 
 
 
 

 
Tablet 1 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Oral
60
5
Risperdal

 
 
1589
 Schizophrenia
 
 
 
 

 
 
2272
 Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder
 
 
 
 

 
Tablet 1 mg (orally disintegrating)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Oral
56
5
Risperdal Quicklet

 
 
1589
 Schizophrenia
 
 
 
 

 
 
2272
 Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder
 
 
 
 

 
Tablet 2 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Oral
60
5
Risperdal

 
 
1589
 Schizophrenia
 
 
 
 

 
 
2272
 Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder
 
 
 
 

 
Tablet 2 mg (orally disintegrating)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Oral
56
5
Risperdal Quicklet

 
 
1589
 Schizophrenia
 
 
 
 

 
 
2272
 Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder
 
 
 
 

Rituximab
Solution for I.V. infusion 100 mg in 10 mL
 
In compliance with authority procedures set out in subparagraph 11 (d):
Treatment of previously untreated, CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy
Treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B-cell non-Hodgkin's lymphoma, in combination with chemotherapy
Injection
2
7
Mabthera

 
Solution for I.V. infusion 500 mg in 50 mL
 
In compliance with authority procedures set out in subparagraph 11 (d):
Treatment of previously untreated, CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy
Treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B-cell non-Hodgkin's lymphoma, in combination with chemotherapy
Injection
1
7
Mabthera

"S-26 LF"
Infant formula powder 900 g
 
In compliance with authority procedures set out in subparagraph 11 (d):
Proven chronic lactose intolerance in patients up to the age of 12 months, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet
Oral
5
5
S-26 LF

Sertraline
Tablet 50 mg (as hydrochloride)
 
Obsessive-compulsive disorder
Panic disorder where other treatments have failed or are inappropriate
Oral
30
5
Eleva 50
Xydep 50
Zoloft

 
Tablet 100 mg (as hydrochloride)
 
Obsessive-compulsive disorder
Panic disorder where other treatments have failed or are inappropriate
Oral
30
5
Eleva 100
Xydep 100
Zoloft

Temazepam
Tablet 10 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Malignant neoplasia (late stage)
Oral
50
5
Normison
Temaze
Temtabs

 
 
 
For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
 
 
 
 

 
 
 
For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
 
 
 
 

Temozolomide
Capsule 5 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Recurrence of anaplastic astrocytoma following standard therapy
Oral
5
5
Temodal

 
 
 
Recurrence of glioblastoma multiforme following standard therapy
 
 
 
 

 
 
 
Glioblastoma multiforme following radiotherapy
 
 
 
 

 
Capsule 20 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Recurrence of anaplastic astrocytoma following standard therapy
Oral
5
5
Temodal

 
 
 
Recurrence of glioblastoma multiforme following standard therapy
 
 
 
 

 
 
 
Glioblastoma multiforme following radiotherapy
 
 
 
 

 
Capsule 100 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Recurrence of anaplastic astrocytoma following standard therapy
Oral
5
5
Temodal

 
 
 
Recurrence of glioblastoma multiforme following standard therapy
 
 
 
 

 
 
 
Glioblastoma multiforme following radiotherapy
 
 
 
 

Topiramate
Tablet 25 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
Oral
60
5
Topamax

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
 
 
 
 

 
Tablet 50 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
Oral
60
5
Topamax

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
 
 
 
 

 
Tablet 100 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
Oral
60
5
Topamax

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
 
 
 
 

 
Tablet 200 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
Oral
60
5
Topamax

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
 
 
 
 

 
Capsule 15 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
Oral
60
5
Topamax Sprinkle

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid form dose of topiramate, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
 
 
 
 

 
Capsule 25 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
Oral
60
5
Topamax Sprinkle

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid form dose of topiramate, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
 
 
 
 

 
Capsule 50 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
Oral
60
5
Topamax Sprinkle

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
 
 
 
 

 
 
 
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid form dose of topiramate, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
 
 
 
 

Tramadol
Capsule containing tramadol hydrochloride 50 mg
 
For dosage titration in chronic pain where aspirin or paracetamol alone is inappropriate or has failed
Oral
20
2
Chem mart Tramadol
GenRx Tramadol
Terry White Chemists Tramadol
Tramal
Tramedo
Zydol

 
 
 
 
 
 
 

 
 
 
 
 
 
 

 
 
 
 
 
 
 

 
 
 
 
 
 
 

 
 
 
 
 
 
 

 
Tablet containing tramadol hydrochloride 50 mg (sustained release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain not responding to non-narcotic analgesics
Oral
40
..
Tramal SR 50

 
Tablet containing tramadol hydrochloride 100 mg (sustained release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain not responding to non-narcotic analgesics
Oral
40
..
Tramahexal SR
Tramal SR 100
Zydol SR 100

 
Tablet containing tramadol hydrochloride 150 mg (sustained release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain not responding to non-narcotic analgesics
Oral
40
..
Tramahexal SR
Tramal SR 150
Zydol SR 150

 
Tablet containing tramadol hydrochloride 200 mg (sustained release)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain not responding to non-narcotic analgesics
Oral
40
..
Tramahexal SR
Tramal SR 200
Zydol SR 200

 
Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain not responding to non-narcotic analgesics
Oral
2
..
Tramal

Valaciclovir
Tablet 500 mg (as hydrochloride)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis
Oral
30
5
Valtrex

 
Tablet 500 mg (as hydrochloride)
 
In compliance with authority procedures set out in subparagraph 11 (d):
Treatment of patients with herpes zoster within 72 hours of the onset of the rash
Herpes zoster ophthalmicus
Oral
42
..
Valtrex

Vancomycin
Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)
 
Endophthalmitis
Use initiated in a hospital for infections where vancomycin hydrochloride is an appropriate antibiotic
Injection
5
..
Mayne Pharma Pty Ltd
Vancocin

Zolmitriptan
Tablet 2.5 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where adverse events have occurred with other suitable PBS-listed drugs
Oral
4
5
Zomig

 
 
 
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where drug interactions have occurred with other suitable PBS-listed drugs
 
 
 
 

 
 
 
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where drug interactions are expected to occur with other suitable PBS-listed drugs
 
 
 
 

 
 
 
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where transfer to another suitable PBS-listed drug would cause patient confusion resulting in problems with compliance
 
 
 
 

 
 
 
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where transfer to another suitable PBS-listed drug is likely to result in adverse clinical consequences
 
 
 
 


Benzydamine
Mouth and throat rinse containing benzydamine hydrochloride 22.5 mg per 15 mL, 500 mL
Oral application
1
..
Difflam

Bisacodyl
Tablet 5 mg
Oral
200
..
Bisalax
Lax-Tab

 
Suppositories 10 mg, 10
Rectal
3
..
Durolax
Petrus Bisacodyl Suppositories

 
Suppositories 10 mg, 12
Rectal
3
..
Fleet Laxative Suppositories
Petrus Bisacodyl Suppositories

 
Enemas 10 mg in 5 mL, 25
Rectal
1
..
Bisalax

Carmellose
Mouth spray containing carmellose sodium 10 mg per mL, 25 mL
Oral application
1
..
Aquae

 
Mouth spray containing carmellose sodium 10 mg per mL, 100 mL
Oral application
1
..
Aquae

Clonazepam
Tablet 500 micrograms
Oral
100
..
Paxam 0.5
Rivotril

 
Tablet 2 mg
Oral
100
..
Paxam 2
Rivotril

 
Oral liquid 2.5 mg per mL, 10 mL
Oral
2
..
Rivotril

Diazepam
Tablet 2 mg
Oral
50
..
Antenex 2

 
 
 
 
 
Ducene

 
 
 
 
 
Valium

 
 
 
 
 
Valpam 2

 
Tablet 5 mg
Oral
50
..
Antenex 5

 
 
 
 
 
Diazepam-DP

 
 
 
 
 
Ducene

 
 
 
 
 
Valium

 
 
 
 
 
Valpam 5

Diclofenac
Tablet (enteric coated) containing diclofenac sodium 25 mg
Oral
100
..
Chem mart Diclofenac

 
 
 
 
 
Clonac 25

 
 
 
 
 
Diclohexal

 
 
 
 
 
Dinac

 
 
 
 
 
Fenac 25

 
 
 
 
 
GenRx Diclofenac

 
 
 
 
 
Terry White Chemists Diclofenac

 
 
 
 
 
Voltaren 25

 
Tablet (enteric coated) containing diclofenac sodium 50 mg
Oral
50
..
Chem mart Diclofenac

 
 
 
 
 
Clonac 50

 
 
 
 
 
Diclohexal

 
 
 
 
 
Dinac

 
 
 
 
 
Fenac

 
 
 
 
 
GenRx Diclofenac

 
 
 
 
 
Terry White Chemists Diclofenac

 
 
 
 
 
Voltaren 50

 
Suppository containing diclofenac sodium 100 mg
Rectal
40
..
Voltaren 100

Glycerol
Suppositories 700 mg, 12
Rectal
3
..
Petrus Pharmaceuticals Pty Ltd

 
Suppositories 1.4 g, 12
Rectal
3
..
Petrus Pharmaceuticals Pty Ltd

 
Suppositories 2.8 g, 12
Rectal
3
..
Petrus Pharmaceuticals Pty Ltd

Hyoscine
Injection containing hyoscine butylbromide 20 mg in 1 mL
Injection
5
..
Buscopan

Ibuprofen
Tablet 200 mg
Oral
100
..
Rafen 200

 
Tablet 400 mg
Oral
90
..
Brufen

Indomethacin
Capsule 25 mg
Oral
100
..
Arthrexin
Indocid

 
Suppository 100 mg
Rectal
40
..
Indocid

Lactulose
Solution BP 3.34 g per 5 mL, 500 mL
Oral
1
..
Actilax

 
 
 
 
 
Duphalac

 
 
 
 
 
Genlac

 
 
 
 
 
GenRx Lactulose

 
 
 
 
 
Lac-Dol

 
 
 
 
 
Lactocur

Macrogol 3350
Sachets containing powder for oral solution 13.125 g with electrolytes, 30
Oral
1
..
Movicol

Methadone
Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL
Oral
1
..
GlaxoSmithKline Australia Pty Ltd

Morphine
Tablet containing morphine sulfate 10 mg
Oral
20
..
Sevredol

 
Tablet containing morphine sulfate 20 mg
Oral
20
..
Sevredol

 
Tablet containing morphine sulfate 200 mg (controlled release)
Oral
20
..
MS Contin

Naproxen
Tablet containing naproxen sodium 550 mg
Oral
50
..
Anaprox 550
Crysanal

 
Tablet 250 mg
Oral
100
..
Inza 250
Naprosyn

 
Tablet 500 mg
Oral
50
..
Inza 500
Naprosyn

 
Tablet 750 mg (sustained release)
Oral
28
..
Naprosyn SR750
Proxen SR 750

 
Tablet 1 g (sustained release)
Oral
28
..
Naprosyn SR1000
Proxen SR 1000

 
Oral suspension 125 mg per 5 mL, 474 mL
Oral
1
..
Naprosyn

Nitrazepam
Tablet 5 mg
Oral
50
..
Alodorm
Mogadon

Oxazepam
Tablet 15 mg
Oral
50
..
Alepam 15
Serepax

 
Tablet 30 mg
Oral
50
..
Alepam 30
Murelax
Serepax

Paracetamol
Tablet 665 mg (modified release)
Oral
192
..
Duatrol SR
Panadol Osteo

 
Suppositories 500 mg, 24
Rectal
1
..
Panadol

Promethazine
Tablet containing promethazine hydrochloride 10 mg
Oral
50
..
Phenergan

 
Tablet containing promethazine hydrochloride 25 mg
Oral
50
..
Phenergan

 
Oral liquid containing promethazine hydrochloride 5 mg per 5 mL, 100 mL
Oral
1
..
Phenergan

Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate
Enemas 3.125 g-450 mg-45 mg in 5 mL, 12
Rectal
2
..
Microlax

Sterculia with Frangula Bark
Granules 620 mg-80 mg per g, 500 g
Oral
1
..
Normacol Plus

Sulindac
Tablet 100 mg
Oral
100
..
Aclin

 
Tablet 200 mg
Oral
50
..
Aclin 200

Temazepam
Tablet 10 mg
Oral
50
..
Normison
Temaze
Temtabs


Benzydamine
Mouth and throat rinse containing benzydamine hydrochloride 22.5 mg per 15 mL, 500 mL
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where a painful mouth is a problem
Continuing supply for palliative care patients where a painful mouth is a problem, and where consultation with a palliative care specialist or service has occurred
Oral application
1
3
Difflam

Bisacodyl
Tablet 5 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
200
3
Bisalax
Lax-Tab

 
Suppositories 10 mg, 10
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Rectal
3
3
Durolax
Petrus Bisacodyl Suppositories

 
Suppositories 10 mg, 12
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Rectal
3
3
Fleet Laxative Suppositories
Petrus Bisacodyl Suppositories

 
Enemas 10 mg in 5 mL, 25
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Rectal
1
3
Bisalax

Carmellose
Mouth spray containing carmellose sodium 10 mg per mL, 25 mL
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where dry mouth is a symptom
Continuing supply for palliative care patients where dry mouth is a symptom, and where consultation with a palliative care specialist or service has occurred
Oral application
1
3
Aquae

 
Mouth spray containing carmellose sodium 10 mg per mL, 100 mL
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where dry mouth is a symptom
Continuing supply for palliative care patients where dry mouth is a symptom, and where consultation with a palliative care specialist or service has occurred
Oral application
1
3
Aquae

Clonazepam
Tablet 500 micrograms
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients for the prevention of epilepsy
Continuing supply for palliative care patients for the prevention of epilepsy, where consultation with a palliative care specialist or service has occurred
Oral
100
3
Paxam 0.5
Rivotril

 
Tablet 2 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients for the prevention of epilepsy
Continuing supply for palliative care patients for the prevention of epilepsy, where consultation with a palliative care specialist or service has occurred
Oral
100
3
Paxam 2
Rivotril

 
Oral liquid 2.5 mg per mL, 10 mL
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients for the prevention of epilepsy
Continuing supply for palliative care patients for the prevention of epilepsy, where consultation with a palliative care specialist or service has occurred
Oral
2
3
Rivotril

Diazepam
Tablet 2 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem
Continuing supply for palliative care patients where anxiety is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
50
3
Antenex 2
Ducene
Valium
Valpam 2

 
Tablet 5 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem
Continuing supply for palliative care patients where anxiety is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
50
3
Antenex 5
Diazepam-DP
Ducene
Valium
Valpam 5

 

Diclofenac
Tablet (enteric coated) containing diclofenac sodium 25 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
100
3
Chem mart Diclofenac
Clonac 25
Diclohexal
Dinac
Fenac 25
GenRx Diclofenac
Terry White Chemists Diclofenac
Voltaren 25

 
 
 
 
 
 

 
 
 
 
 
 

 
 
 
 
 
 

 
 
 
 
 
 

 
 
 
 
 
 

 
 
 
 
 
 

 
Tablet (enteric coated) containing diclofenac sodium 50 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
50
3
Chem mart Diclofenac
Clonac 50
Diclohexal
Dinac
Fenac
GenRx Diclofenac
Terry White Chemists Diclofenac
Voltaren 50

 
 
 
 
 
 

 
 
 
 
 
 

 
 
 
 
 
 

 
 
 
 
 
 

 
 
 
 
 
 

 
 
 
 
 
 

 
Suppository containing diclofenac sodium 100 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Rectal
40
3
Voltaren 100

Glycerol
Suppositories 700 mg, 12
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Rectal
3
3
Petrus Pharmaceuticals Pty Ltd

 
Suppositories 1.4 g, 12
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Rectal
3
3
Petrus Pharmaceuticals Pty Ltd

 
Suppositories 2.8 g, 12
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Rectal
3
3
Petrus Pharmaceuticals Pty Ltd

Hyoscine
Injection containing hyoscine butylbromide 20 mg in 1 mL
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where colicky pain is a symptom
Continuing supply for palliative care patients where colicky pain is a symptom, and where consultation with a palliative care specialist or service has occurred
Injection
5
3
Buscopan

Ibuprofen
Tablet 200 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
100
3
Rafen 200

 
Tablet 400 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
90
3
Brufen

Indomethacin
Capsule 25 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
100
3
Arthrexin
Indocid

 
Suppository 100 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Rectal
40
3
Indocid

Lactulose
Solution BP 3.34 g per 5 mL, 500 mL
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
1
3
Actilax
Duphalac
Genlac
GenRx Lactulose
Lac-Dol
Lactocur

Macrogol 3350
Sachets containing powder for oral solution 13.125 g with electrolytes, 30
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
1
3
Movicol

Methadone
Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non-narcotic analgesics
Continuing supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non-narcotic analgesics, and where consultation with a palliative care specialist or service has occurred
Oral
1
2
GlaxoSmithKline Australia Pty Ltd

Morphine
Tablet containing morphine sulfate 10 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 3 months, for palliative care patients with severe disabling pain not responding to non-narcotic analgesics
Continuing supply, for up to 3 months, for palliative care patients with severe disabling pain not responding to non-narcotic analgesics, and where consultation with a palliative care specialist or service has occurred
Oral
20
2
Sevredol

 
Tablet containing morphine sulfate 20 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 3 months, for palliative care patients with severe disabling pain not responding to non-narcotic analgesics
Continuing supply, for up to 3 months, for palliative care patients with severe disabling pain not responding to non-narcotic analgesics, and where consultation with a palliative care specialist or service has occurred
Oral
20
2
Sevredol

 
Tablet containing morphine sulfate 200 mg (controlled release)
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non-narcotic analgesics
Continuing supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non-narcotic analgesics, and where consultation with a palliative care specialist or service has occurred
Oral
20
2
MS Contin

Naproxen
Tablet 250 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
100
3
Inza 250
Naprosyn

 
Tablet containing naproxen sodium 550 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
50
3
Anaprox 550
Crysanal

 
Tablet 500 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
50
3
Inza 500
Naprosyn

 
Tablet 750 mg (sustained release)
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
28
3
Naprosyn SR750
Proxen SR 750

 
Tablet 1 g (sustained release)
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
28
3
Naprosyn SR1000
Proxen SR 1000

 
Oral suspension 125 mg per 5 mL, 474 mL
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem in patients unable to take a solid dose form of a non-steroidal anti-inflammatory agent
Continuing supply for palliative care patients where severe pain is a problem in patients unable to take a solid dose form of a non-steroidal anti-inflammatory agent, and where consultation with a palliative care specialist or service has occurred
Oral
1
3
Naprosyn

Nitrazepam
Tablet 5 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where insomnia is a problem
Continuing supply for palliative care patients where insomnia is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
50
3
Alodorm
Mogadon

Oxazepam
Tablet 15 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem
Continuing supply for palliative care patients where anxiety is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
50
3
Alepam 15
Serepax

 
Tablet 30 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem
Continuing supply for palliative care patients where anxiety is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
50
3
Alepam 30
Murelax
Serepax

Paracetamol
Tablet 665 mg (modified release)
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated
Continuing supply for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated, and where consultation with a palliative care specialist or service has occurred
Oral
192
3
Duatrol SR
Panadol Osteo

 
Suppositories 500 mg, 24
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated
Continuing supply for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated, and where consultation with a palliative care specialist or service has occurred
Rectal
1
3
Panadol

Promethazine
Tablet containing promethazine hydrochloride 10 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where nausea and/or vomiting is a problem
Continuing supply for palliative care patients where nausea and/or vomiting is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
50
3
Phenergan

 
Tablet containing promethazine hydrochloride 25 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where nausea and/or vomiting is a problem
Continuing supply for palliative care patients where nausea and/or vomiting is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
50
3
Phenergan

 
Oral liquid containing promethazine hydrochloride 5 mg per 5 mL, 100 mL
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where nausea and/or vomiting is a problem
Continuing supply for palliative care patients where nausea and/or vomiting is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
1
3
Phenergan

Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate
Enemas 3.125 g-450 mg-45 mg in 5 mL, 12
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Rectal
2
3
Microlax

Sterculia with Frangula Bark
Granules 620 mg-80 mg per g, 500 g
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
1
3
Normacol Plus

Sulindac
Tablet 100 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
100
3
Aclin

 
Tablet 200 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
50
3
Aclin 200

Temazepam
Tablet 10 mg
In compliance with authority procedures set out in subparagraph 11 (d):
Initial supply, for up to 4 months, for palliative care patients where insomnia is a problem
Continuing supply for palliative care patients where insomnia is a problem, and where consultation with a palliative care specialist or service has occurred
Oral
50
3
Normison
Temaze
Temtabs


Adrenaline
Injection 1 mg (as acid tartrate) in 1 mL (1 in 1,000)
Injection
5
..
AstraZeneca Pty Ltd

Amoxycillin
Tablet, chewable, 250 mg (as trihydrate)
Oral
20
..
Amoxil

 
Capsule 250 mg (as trihydrate)
Oral
20
..
Alphamox 250

 
 
 
 
 
Amohexal

 
 
 
 
 
Amoxil

 
 
 
 
 
Amoxycillin-DP

 
 
 
 
 
Chem mart Amoxycillin

 
 
 
 
 
Cilamox

 
 
 
 
 
GenRx Amoxycillin

 
 
 
 
 
Terry White Chemists Amoxycillin

 
Capsule 500 mg (as trihydrate)
Oral
20
..
Alphamox 500

 
 
 
 
 
Amohexal

 
 
 
 
 
Amoxil

 
 
 
 
 
Amoxycillin-DP

 
 
 
 
 
Chem mart Amoxycillin

 
 
 
 
 
Cilamox

 
 
 
 
 
GenRx Amoxycillin

 
 
 
 
 
Moxacin

 
 
 
 
 
Terry White Chemists Amoxycillin

 
Sachet containing oral powder 3 g (as trihydrate)
Oral
1
..
Amoxil

 
Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL
Oral
1
..
Amoxil

 
Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL
Oral
1
..
Alphamox 125
Amohexal
Amoxil
Bgramin
Chem mart Amoxycillin
GenRx Amoxycillin
Terry White Chemists Amoxycillin

 
 
 
 
 

 
 
 
 
 

 
 
 
 
 

 
 
 
 
 

 
 
 
 
 

 
 
 
 
 

 
Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL
Oral
1
..
Alphamox 250
Amohexal
Amoxil Forte
Bgramin
Chem mart Amoxycillin

 
 
 
 
 

 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
Cilamox

 
 
 
 
 
GenRx Amoxycillin

 
 
 
 
 
Terry White Chemists Amoxycillin

 
Powder for oral suspension 500 mg (as trihydrate) per 5 mL, 100 mL
Oral
1
..
Maxamox

Amoxycillin with Clavulanic Acid
Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
Oral
10
..
Augmentin Duo
Clamohexal Duo 500mg/125mg
Clamoxyl Duo
Clavulin Duo
Curam 500/125
Moxiclav Duo 500/125

 
 
 
 
 

 
 
 
 
 

 
 
 
 
 

 
 
 
 
 

 
Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
Oral
10
..
Augmentin Duo forte
Chem mart Amoxycillin and Clavulanic Acid

 
 
 
 
 

 
 
 
 
 
Clamohexal Duo Forte 875mg/125mg

 
 
 
 
 
Clamoxyl Duo forte

 
 
 
 
 
Clavulin Duo Forte

 
 
 
 
 
Clavycillin 875/125

 
 
 
 
 
Curam 875/125

 
 
 
 
 
GenRx Amoxycillin and Clavulanic Acid

 
 
 
 
 
Moxiclav Duo Forte 875/125

 
 
 
 
 
Terry White Chemists Amoxycillin and Clavulanic Acid

 
Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL
Oral
1
..
Augmentin
Clamohexal 125mg/31.25mg/5mL
Clamoxyl
Clavulin

 
 
 
 
 

 
 
 
 
 

 
Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL
Oral
1
..
Augmentin Duo 400
Clamohexal Duo 400mg/57mg/5mL
Clamoxyl Duo 400

 
 
 
 
 

 
 
 
 
 
Clavulin Duo 400

Amphotericin
Lozenge 10 mg
Oral
20
..
Fungilin

Ampicillin
Capsule 250 mg (as trihydrate)
Oral
24
..
Alphacin 250

 
Capsule 500 mg (as trihydrate)
Oral
24
..
Alphacin 500

 
Powder for injection 500 mg (as sodium)
Injection
5
..
Austrapen
Ibimicyn

 
Powder for injection 1 g (as sodium)
Injection
5
..
Aspen Ampicyn
Austrapen
Ibimicyn

Aspirin
Tablet, dispersible, 300 mg
Oral
96
..
Solprin

Atropine
Injection containing atropine sulfate 600 micrograms in 1 mL
Injection
10
..
AstraZeneca Pty Ltd

Benzathine Penicillin
Injection 900 mg in 2 mL cartridge-needle unit (for use with Tubex Injector)
Injection
1
..
Bicillin L-A Tubex

 
Powder for injection 900 mg
Injection
1
..
Pan Benzathine Benzylpenicillin

Benztropine
Injection containing benztropine mesylate 2 mg in 2 mL
Injection
5
..
Cogentin

Benzydamine
Mouth and throat rinse containing benzydamine hydrochloride 22.5 mg per 15 mL, 500 mL
Oral application
1
..
Difflam

Benzylpenicillin
Powder for injection 600 mg (as sodium)
Injection
10
..
BenPen

 
Powder for injection 3 g (as sodium)
Injection
10
..
BenPen

Betamethasone
Injection containing betamethasone acetate 3 mg with betamethasone sodium phosphate 3.9 mg in 1 mL
Injection
5
..
Celestone Chronodose

Carbamazepine
Tablet 100 mg
Oral
200
..
Carbamazepine Sandoz
Tegretol 100

 
Tablet 200 mg
Oral
200
..
Carbamazepine Sandoz
Tegretol 200
Teril

 
Tablet 200 mg (controlled release)
Oral
200
..
Tegretol CR 200

 
Tablet 400 mg (controlled release)
Oral
200
..
Tegretol CR 400

 
Oral suspension 100 mg per 5 mL, 300 mL
Oral
1
..
Tegretol Liquid

Cefaclor
Tablet (sustained release) 375 mg (as monohydrate)
Oral
10
..
Ceclor CD

 
 
 
 
 
Chem mart Cefaclor CD

 
 
 
 
 
Douglas Cefaclor-CD

 
 
 
 
 
GenRx Cefaclor CD

 
 
 
 
 
Karlor CD

 
 
 
 
 
Keflor CD

 
 
 
 
 
Ozcef

 
 
 
 
 
Terry White Chemists Cefaclor CD

 
Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL
Oral
1
..
Aclor 125
Ceclor
Chem mart Cefaclor
GenRx Cefaclor
Keflor
Terry White Chemists Cefaclor

 
 
 
 
 

 
 
 
 
 

 
 
 
 
 

 
 
 
 
 

 
Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL
Oral
1
..
Aclor 250
Ceclor
Chem mart Cefaclor
GenRx Cefaclor
Keflor
Terry White Chemists Cefaclor

 
 
 
 
 

 
 
 
 
 

 
 
 
 
 

 
 
 
 
 

Cefotaxime
Powder for injection 1 g (as sodium)
Injection
10
..
Cefotaxime Sandoz
Mayne Pharma Pty Ltd

 
Powder for injection 2 g (as sodium)
Injection
10
..
Cefotaxime Sandoz
Mayne Pharma Pty Ltd

Cefuroxime
Tablet 250 mg (as axetil)
Oral
14
..
Zinnat

Cephalexin
Capsule 250 mg (anhydrous)
Oral
20
..
Chem mart Cephalexin

 
 
 
 
 
Cilex

 
 
 
 
 
GenRx Cephalexin

 
 
 
 
 
Ialex

 
 
 
 
 
Ibilex 250

 
 
 
 
 
Keflex

 
 
 
 
 
Rancef

 
 
 
 
 
Sporahexal

 
 
 
 
 
Terry White Chemists Cephalexin

 
Capsule 500 mg (anhydrous)
Oral
20
..
Chem mart Cephalexin

 
 
 
 
 
Cilex

 
 
 
 
 
GenRx Cephalexin

 
 
 
 
 
Ialex

 
 
 
 
 
Ibilex 500

 
 
 
 
 
Keflex

 
 
 
 
 
Rancef

 
 
 
 
 
Sporahexal

 
 
 
 
 
Terry White Chemists Cephalexin

 
Granules for oral suspension 125 mg per 5 mL, 100 mL
Oral
1
..
Chem mart Cephalexin

 
 
 
 
 
Cilex

 
 
 
 
 
GenRx Cephalexin

 
 
 
 
 
Ialex

 
 
 
 
 
Ibilex 125

 
 
 
 
 
Keflex

 
 
 
 
 
Terry White Chemists Cephalexin

 
Granules for oral suspension 250 mg per 5 mL, 100 mL
Oral
1
..
Chem mart Cephalexin

 
 
 
 
 
Cilex

 
 
 
 
 
GenRx Cephalexin

 
 
 
 
 
Ialex

 
 
 
 
 
Ibilex 250

 
 
 
 
 
Keflex

 
 
 
 
 
Terry White Chemists Cephalexin

Cephalothin
Powder for injection 1 g (as sodium)
Injection
10
..
Keflin Neutral
Mayne Pharma Pty Ltd

Chloramphenicol
Eye drops 5 mg per mL, 10 mL
Application to the eye
1
..
Chloromycetin
Chlorsig

Clindamycin
Capsule 150 mg (as hydrochloride)
Oral
25
..
Cleocin
Dalacin C

Codeine
Tablet containing codeine phosphate 30 mg
Oral
20
..
Fawns and McAllan Pty Ltd

Codeine with Paracetamol
Tablet containing codeine phosphate 30 mg with paracetamol 500 mg
Oral
20
..
Codalgin Forte
Codapane Forte
Dolaforte
Dymadon Forte
Panadeine Forte
Prodeine Forte

 
 
 
 
 

 
 
 
 
 

 
 
 
 
 

 
 
 
 
 

Diazepam
Tablet 2 mg
Oral
50
..
Antenex 2

 
 
 
 
 
Ducene

 
 
 
 
 
Valium

 
 
 
 
 
Valpam 2

 

 
Tablet 5 mg
Oral
50
..
Antenex 5

 
 
 
 
 
Diazepam-DP

 
 
 
 
 
Ducene

 
 
 
 
 
Valium

 
 
 
 
 
Valpam 5

 
Injection 10 mg in 2 mL ampoule
Injection
5
..
Mayne Pharma Pty Ltd

Diclofenac
Tablet (enteric coated) containing diclofenac sodium 25 mg
Oral
100
..
Chem mart Diclofenac

 
 
 
 
 
Clonac 25

 
 
 
 
 
Diclohexal

 
 
 
 
 
Dinac

 
 
 
 
 
Fenac 25

 
 
 
 
 
GenRx Diclofenac

 
 
 
 
 
Terry White Chemists Diclofenac

 
 
 
 
 
Voltaren 25

 
Tablet (enteric coated) containing diclofenac sodium 50 mg
Oral
50
..
Chem mart Diclofenac

 
 
 
 
 
Clonac 50

 
 
 
 
 
Diclohexal

 
 
 
 
 
Dinac

 
 
 
 
 
Fenac

 
 
 
 
 
GenRx Diclofenac

 
 
 
 
 
Terry White Chemists Diclofenac

 
 
 
 
 
Voltaren 50

 
Suppository containing diclofenac sodium 100 mg
Rectal
40
..
Voltaren 100

Dicloxacillin
Capsule 250 mg (as sodium)
Oral
24
..
Diclocil
Dicloxsig
Distaph 250

 
Capsule 500 mg (as sodium)
Oral
24
..
Diclocil
Dicloxsig
Distaph 500

 
Powder for injection 500 mg (as sodium)
Injection
5
..
Diclocil

 
Powder for injection 1 g (as sodium)
Injection
5
..
Diclocil

 

Doxycycline
Tablet 100 mg (as hydrochloride)
Oral
7
..
Doxsig

 
 
 
 
 
Doxy-100

 
 
 
 
 
Doxylin 100

 
 
 
 
 
Vibramycin

 
Tablet 100 mg (as monohydrate)
Oral
7
..
Chem mart Doxycycline

 
 
 
 
 
Doxyhexal

 
 
 
 
 
GenRx Doxycycline

 
 
 
 
 
Terry White Chemists Doxycycline

 
Capsule 100 mg (as hydrochloride) (containing enteric coated pellets)
Oral
7
..
DBL Doxycycline
Doryx

Erythromycin
Tablet 400 mg (as ethyl succinate)
Oral
25
..
E.E.S. 400 Filmtab
E-Mycin

 
Capsule 250 mg (containing enteric coated pellets)
Oral
25
..
DBL Erythromycin
Eryc

 
Powder for oral liquid 200 mg (as ethyl succinate) per 5 mL, 100 mL
Oral
1
..
E.E.S. 200
E-Mycin 200

 
Powder for oral liquid 400 mg (as ethyl succinate) per 5 mL, 100 mL
Oral
1
..
E.E.S. Granules
E-Mycin 400

 
Powder for I.V. infusion 1 g (as lactobionate)
Injection
5
..
Erythrocin-I.V.

Flucloxacillin
Capsule 250 mg (as sodium)
Oral
24
..
Flopen
Floxapen
Staphylex 250

 
Capsule 500 mg (as sodium)
Oral
24
..
Flopen
Floxapen
Staphylex 500

 
Powder for oral suspension 125 mg (as magnesium) per 5 mL, 100 mL
Oral
1
..
Floxapen

 
Powder for oral suspension 250 mg (as magnesium) per 5 mL, 100 mL
Oral
1
..
Flopen
Floxapen

 
Powder for injection 500 mg (as sodium)
Injection
5
..
Flopen
Flubiclox

 
Powder for injection 1 g (as sodium)
Injection
5
..
Aspen Flucil

 
 
 
 
 
Flopen

 
 
 
 
 
Flubiclox

 
 
 
 
 
Mayne Pharma Pty Ltd

Glucagon
Injection set containing glucagon hydrochloride 1 mg (1 I.U.) and 1 mL solvent in disposable syringe
Injection
1
..
GlucaGen Hypokit

Glucose
I.V. infusion 278 mmol (anhydrous) per L, 1 L
Injection
5
..
Baxter Healthcare Pty Limited

Glyceryl Trinitrate
Tablets 600 micrograms, 100
Buccal/sublingual
1
..
Anginine Stabilised
Lycinate

Hydrocortisone
Injection 100 mg (as sodium succinate) with 2 mL solvent
Injection
6
..
Solu-Cortef

 
Injection 250 mg (as sodium succinate) with 2 mL solvent
Injection
6
..
Solu-Cortef

 
Cream containing hydrocortisone acetate 10 mg per g, 30 g
Application
1
..
Cortic-DS 1%
Sigmacort

 
Cream containing hydrocortisone acetate 10 mg per g, 50 g
Application
1
..
Cortef
Cortic-DS 1%
Sigmacort

 
Ointment containing hydrocortisone acetate 10 mg per g, 30 g
Application
1
..
Cortic-DS 1%
Sigmacort

 
Ointment containing hydrocortisone acetate 10 mg per g, 50 g
Application
1
..
Cortic-DS 1%
Sigmacort

Hydromorphone
Tablet containing hydromorphone hydrochloride 2 mg
Oral
20
..
Dilaudid

 
Tablet containing hydromorphone hydrochloride 4 mg
Oral
20
..
Dilaudid

 
Tablet containing hydromorphone hydrochloride 8 mg
Oral
20
..
Dilaudid

 
Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 473 mL
Oral
1
..
Dilaudid

 
Injection containing hydromorphone hydrochloride 2 mg in 1 mL
Injection
5
..
Dilaudid

 
Injection containing hydromorphone hydrochloride 10 mg in 1 mL
Injection
5
..
Dilaudid-HP

 
Injection containing hydromorphone hydrochloride 50 mg in 5 mL
Injection
5
..
Dilaudid-HP

Ibuprofen
Tablet 200 mg
Oral
100
..
Rafen 200

 
Tablet 400 mg
Oral
30
..
Brufen

Indomethacin
Capsule 25 mg
Oral
100
..
Arthrexin
Indocid

 
Suppository 100 mg
Rectal
40
..
Indocid

Ketoprofen
Capsule 200 mg (sustained release)
Oral
28
..
Orudis SR 200
Oruvail SR

 
Suppository 100 mg
Rectal
40
..
Orudis

Lignocaine
Injection containing lignocaine hydrochloride 100 mg in 5 mL
Injection
5
..
Pfizer Pty Limited

Lincomycin
Injection 600 mg (as hydrochloride) in 2 mL
Injection
5
..
Lincocin

Methylprednisolone
Injection containing methylprednisolone acetate 40 mg in 1 mL
Injection
5
..
Depo-Medrol
Depo-Nisolone

Metoclopramide
Tablet containing metoclopramide hydrochloride 10 mg
Oral
25
..
Maxolon
Pramin

 
Injection containing metoclopramide hydrochloride 10 mg in 2 mL
Injection
10
..
Maxolon

Metronidazole
Tablet 200 mg
Oral
21
..
Flagyl
Metrogyl 200
Metronide 200

 
Tablet 400 mg
Oral
5
..
Metrogyl 400

 
Oral suspension containing metronidazole benzoate 320 mg per 5 mL, 100 mL
Oral
1
..
Flagyl S

 
I.V. infusion 500 mg in 100 mL
Injection
5
..
Baxter Healthcare Pty Limited

 
Suppositories 500 mg, 10
Rectal
1
..
Flagyl

Morphine
Tablet containing morphine sulfate 30 mg
Oral
20
..
Anamorph

 
Tablet containing morphine sulfate 5 mg (controlled release)
Oral
20
..
MS Contin

 
Tablet containing morphine sulfate 10 mg (controlled release)
Oral
20
..
MS Contin

 
Tablet containing morphine sulfate 15 mg (controlled release)
Oral
20
..
MS Contin

 
Tablet containing morphine sulfate 30 mg (controlled release)
Oral
20
..
MS Contin

 
Tablet containing morphine sulfate 60 mg (controlled release)
Oral
20
..
MS Contin

 
Tablet containing morphine sulfate 100 mg (controlled release)
Oral
20
..
MS Contin

 
Capsule containing morphine sulfate 10 mg (containing sustained release pellets)
Oral
20
..
Kapanol

 
Capsule containing morphine sulfate 20 mg (containing sustained release pellets)
Oral
20
..
Kapanol

 
Capsule containing morphine sulfate 30 mg (controlled release)
Oral
10
..
MS Mono

 
Capsule containing morphine sulfate 50 mg (containing sustained release pellets)
Oral
20
..
Kapanol

 
Capsule containing morphine sulfate 60 mg (controlled release)
Oral
10
..
MS Mono

 
Capsule containing morphine sulfate 90 mg (controlled release)
Oral
10
..
MS Mono

 
Capsule containing morphine sulfate 100 mg (containing sustained release pellets)
Oral
20
..
Kapanol

 
Capsule containing morphine sulfate 120 mg (controlled release)
Oral
10
..
MS Mono

 
Sachet containing controlled release granules for oral suspension, containing morphine sulfate 20 mg per sachet
Oral
20
..
MS Contin Suspension 20 mg

 
Sachet containing controlled release granules for oral suspension, containing morphine sulfate 30 mg per sachet
Oral
20
..
MS Contin Suspension 30 mg

 
Sachet containing controlled release granules for oral suspension, containing morphine sulfate 60 mg per sachet
Oral
20
..
MS Contin Suspension 60 mg

 
Sachet containing controlled release granules for oral suspension, containing morphine sulfate 100 mg per sachet
Oral
20
..
MS Contin Suspension 100 mg

 
Oral solution containing morphine hydrochloride 2 mg per mL, 200 mL
Oral
1
..
Ordine 2

 
Oral solution containing morphine hydrochloride 5 mg per mL, 200 mL
Oral
1
..
Ordine 5

 
Oral solution containing morphine hydrochloride 10 mg per mL, 200 mL
Oral
1
..
Ordine 10

 
Injection containing morphine sulfate 10 mg in 1 mL
Injection
5
..
Mayne Pharma Pty Ltd

 
Injection containing morphine sulfate 15 mg in 1 mL
Injection
5
..
Mayne Pharma Pty Ltd

 
Injection containing morphine sulfate 30 mg in 1 mL
Injection
5
..
Mayne Pharma Pty Ltd

Naloxone
Injection containing naloxone hydrochloride 800 micrograms in 2 mL disposable injection set
Injection
1
..
Naloxone Min-I-Jet

 
Injection containing naloxone hydrochloride 2 mg in 5 mL disposable injection set
Injection
1
..
Naloxone Min-I-Jet

Naproxen
Tablet 250 mg
Oral
100
..
Inza 250
Naprosyn

 
Tablet containing naproxen sodium 550 mg
Oral
50
..
Anaprox 550
Crysanal

 
Tablet 500 mg
Oral
50
..
Inza 500
Naprosyn

 
Tablet 750 mg (sustained release)
Oral
28
..
Naprosyn SR750
Proxen SR 750

 
Tablet 1 g (sustained release)
Oral
28
..
Naprosyn SR1000
Proxen SR 1000

Nitrazepam
Tablet 5 mg
Oral
25
..
Alodorm
Mogadon

Nystatin
Tablet 500,000 units
Oral
50
..
Nilstat

 
Capsule 500,000 units
Oral
50
..
Nilstat

 
Oral suspension 100,000 units per mL, 24 mL
Oral
1
..
Mycostatin
Nilstat

Oxazepam
Tablet 15 mg
Oral
25
..
Alepam 15
Serepax

 
Tablet 30 mg
Oral
25
..
Alepam 30
Murelax
Serepax

Oxycodone
Tablet containing oxycodone hydrochloride 5 mg
Oral
20
..
Endone

 
Capsule containing oxycodone hydrochloride 5 mg
Oral
20
..
OxyNorm

 
Capsule containing oxycodone hydrochloride 10 mg
Oral
20
..
OxyNorm

 
Capsule containing oxycodone hydrochloride 20 mg
Oral
20
..
OxyNorm

 
Oral solution containing oxycodone hydrochloride 5 mg per 5 mL, 250 mL
Oral
1
..
OxyNorm Liquid 5mg/5mL

 
Tablet containing oxycodone hydrochloride 5 mg (controlled release)
Oral
20
..
OxyContin

 
Tablet containing oxycodone hydrochloride 10 mg (controlled release)
Oral
20
..
OxyContin

 
Tablet containing oxycodone hydrochloride 20 mg (controlled release)
Oral
20
..
OxyContin

 
Tablet containing oxycodone hydrochloride 40 mg (controlled release)
Oral
20
..
OxyContin

 
Tablet containing oxycodone hydrochloride 80 mg (controlled release)
Oral
20
..
OxyContin

 
Suppository 30 mg (as pectinate)
Rectal
12
..
Proladone

Paracetamol
Tablet 500 mg
Oral
100
..
Chem mart Chemadol

 
 
 
 
 
Dymadon P

 
 
 
 
 
Febridol

 
 
 
 
 
Panamax

 
 
 
 
 
Parahexal

 
 
 
 
 
Paralgin

 
 
 
 
 
Parmol

 
 
 
 
 
Terry White Chemists Paracetamol

 
 
 
 
 
Tylenol

 
Oral liquid 120 mg per 5 mL, 100 mL
Oral
1
..
Panamax

 
Oral liquid 240 mg per 5 mL, 200 mL
Oral
1
..
Panamax 240 Elixir

Phenoxymethylpenicillin
Tablet 250 mg phenoxymethylpenicillin (as potassium)
Oral
50
..
Abbocillin-VK Filmtab

 
Tablet 500 mg phenoxymethylpenicillin (as potassium)
Oral
50
..
Abbocillin-VK Filmtab

 
Capsule 250 mg phenoxymethylpenicillin (as potassium)
Oral
50
..
Cilicaine VK

 
 
 
 
 
Cilopen VK

 
 
 
 
 
LPV

 
 
 
 
 
Penhexal VK

 
Capsule 500 mg phenoxymethylpenicillin (as potassium)
Oral
50
..
Cilicaine VK

 
 
 
 
 
Cilopen VK

 
 
 
 
 
LPV

 
 
 
 
 
Penhexal VK

 
Oral suspension 125 mg (as benzathine) per 5 mL, 100 mL
Oral
2
..
Abbocillin-V
Cilicaine V

 
Oral suspension 250 mg (as benzathine) per 5 mL, 100 mL
Oral
2
..
Abbocillin-V
Cilicaine V

Piroxicam
Dispersible tablet 10 mg
Oral
50
..
Feldene-D

 
 
 
 
 
GenRx Piroxicam Dispersible

 
 
 
 
 
Mobilis D-10

 
 
 
 
 
Pirohexal-D

 
Dispersible tablet 20 mg
Oral
25
..
Chem mart Piroxicam Dispersible

 
 
 
 
 
Feldene-D

 
 
 
 
 
GenRx Piroxicam Dispersible

 
 
 
 
 
Mobilis D-20

 
 
 
 
 
Pirohexal-D

 
 
 
 
 
Terry White Chemists Piroxicam Dispersible

 
Capsule 10 mg
Oral
50
..
Chem mart Piroxicam

 
 
 
 
 
Feldene

 
 
 
 
 
GenRx Piroxicam

 
 
 
 
 
Mobilis 10

 
 
 
 
 
Terry White Chemists Piroxicam

 
Capsule 20 mg
Oral
25
..
Chem mart Piroxicam

 
 
 
 
 
Feldene

 
 
 
 
 
GenRx Piroxicam

 
 
 
 
 
Mobilis 20

 
 
 
 
 
Terry White Chemists Piroxicam

Procaine Penicillin
Injection 1.5 g in disposable syringe
Injection
5
..
Cilicaine

Prochlorperazine
Tablet containing prochlorperazine maleate 5 mg
Oral
25
..
Stemetil
Stemzine

 
Injection containing prochlorperazine mesylate 12.5 mg in 1 mL
Injection
10
..
Stemetil

 
Suppositories 3 mg, equivalent to 5 mg prochlorperazine maleate, 5
Rectal
1
..
Stemetil

 
Suppositories 15 mg, equivalent to 25 mg prochlorperazine maleate, 5
Rectal
1
..
Stemetil

Promethazine
Injection containing promethazine hydrochloride 50 mg in 2 mL
Injection
10
..
Mayne Pharma Pty Ltd

Sodium Chloride
Injection 9 mg per mL, 10 mL
Injection
5
..
Pfizer Pty Limited

 
I.V. infusion 154 mmol per L, 1 L
Injection
5
..
Baxter Healthcare Pty Limited

 
I.V. infusion 513 mmol per L, 1 L
Injection
2
..
Baxter Healthcare Pty Limited

Sodium Chloride with Glucose
I.V. infusion 31 mmol-222 mmol (anhydrous) per L, 1 L
Injection
5
..
Baxter Healthcare Pty Limited

 
I.V. infusion 19 mmol-104 mmol (anhydrous) per 500 mL, 500 mL
Injection
5
..
Baxter Healthcare Pty Limited

 
I.V. infusion 39 mmol-69 mmol (anhydrous) per 500 mL, 500 mL
Injection
5
..
Baxter Healthcare Pty Limited

Sulindac
Tablet 100 mg
Oral
100
..
Aclin

 
Tablet 200 mg
Oral
50
..
Aclin 200

Temazepam
Tablet 10 mg
Oral
25
..
Normison
Temaze
Temtabs

Ticarcillin with Clavulanic Acid
Powder for injection containing ticarcillin 3 g (as sodium) with 100 mg clavulanic acid (as potassium clavulanate) (with any determined brand of sodium chloride injection as the required solvent)
Injection
10
..
Timentin

Tramadol
Capsule containing tramadol hydrochloride 50 mg
Oral
20
..
Chem mart Tramadol

 
 
 
 
 
GenRx Tramadol

 
 
 
 
 
Terry White Chemists Tramadol

 
 
 
 
 
Tramal

 
 
 
 
 
Tramedo

 
 
 
 
 
Zydol

 
Tablet containing tramadol hydrochloride 50 mg (sustained release)
Oral
20
..
Tramal SR 50

 
Tablet containing tramadol hydrochloride 100 mg (sustained release)
Oral
20
..
Tramahexal SR
Tramal SR 100
Zydol SR 100

 
Tablet containing tramadol hydrochloride 150 mg (sustained release)
Oral
20
..
Tramahexal SR
Tramal SR 150
Zydol SR 150

 
Tablet containing tramadol hydrochloride 200 mg (sustained release)
Oral
20
..
Tramahexal SR
Tramal SR 200
Zydol SR 200

 
Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL
Oral
1
..
Tramal

 
Injection containing tramadol hydrochloride 100 mg in 2 mL
Injection
5
..
Tramahexal
Tramal 100

Triamcinolone
Injection containing triamcinolone acetonide 10 mg in 1 mL
Injection
5
..
Kenacort-A10

Trimethoprim with Sulfamethoxazole
Tablet 80 mg-400 mg
Oral
10
..
Resprim
Septrin

 
Tablet 160 mg-800 mg
Oral
10
..
Bactrim DS

 
 
 
 
 
Chem mart Trimethoprim with Sulfamethoxazole DS

 
 
 
 
 
GenRx Trimethoprim with Sulfamethoxazole DS

 
 
 
 
 
Resprim Forte

 
 
 
 
 
Septrin Forte

 
 
 
 
 
Terry White Chemists Trimethoprim with Sulfamethoxazole DS

 
Paediatric oral suspension 40 mg-200 mg per 5 mL, 100 mL
Oral
1
..
Bactrim
Resprim
Septrin

Vancomycin
Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)
Injection
2
..
Mayne Pharma Pty Ltd
Vancocin


Ibuprofen
Tablet 400 mg
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
Oral
90
..
Brufen

Metronidazole
Tablet 400 mg
Treatment of anaerobic infections
Oral
21
..
Flagyl
Metrogyl 400
Metronide 400

Paracetamol
Tablet 500 mg
Chronic arthropathies
Oral
300
..
Chem mart Chemadol

 
 
 
 
 
 
Dymadon P

 
 
 
 
 
 
Febridol

 
 
 
 
 
 
Panamax

 
 
 
 
 
 
Parahexal

 
 
 
 
 
 
Paralgin

 
 
 
 
 
 
Parmol

 
 
 
 
 
 
Terry White Chemists Paracetamol

 
 
 
 
 
 
Tylenol


Creams
100 g
1

Dusting Powders
100 g
1

Ear Drops
15 mL
2

Eye Drops containing Cocaine Hydrochloride BP
15 mL
..

Eye Drops, Other
15 mL
5

Eye Lotions
200 mL
2

Inhalations
50 mL
1

Linctuses containing Codeine Phosphate BP
100 mL
..

Linctuses, Other
100 mL
2

Lotions
200 mL
2

Mixtures containing Codeine Phosphate BP
200 mL
..

Mixtures, Other
200 mL
4

Mixtures for Children containing Codeine Phosphate BP
100 mL
..

Mixtures for Children, Other
100 mL
4

Mouth Washes
200 mL
1

Nasal Instillations
15 mL
2

Ointments, Waxes
100 g
1

Paints
25 mL
1

Pastes containing Cocaine Hydrochloride BP
25 g
..

Pastes, Other
100 g
1

Powders for Internal Use
100 g
2

Solutions
200 mL
2