COMMONWEALTH OF AUSTRALIA
National Health Act 1953
PHARMACEUTICAL BENEFITS
DETERMINATIONS UNDER SECTIONS 85, 85A AND 88
No. PB 45 of 2007
 
I, STEPHEN DELLAR, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing and Delegate of the Minister for Health and Ageing, pursuant to sections 85, 85A and 88 of the National Health Act 1953, hereby make the following Determinations:
1.          These Determinations commence on 1 July 2007.
2.          The Determinations (No. PB 31 of 2007) under sections 85, 85A and 88 of the National Health Act 1953, made on 30 March 2007 with effect from 1 May 2007, as amended on 26 April 2007 with effect from 1 June 2007 (No. PB 38 of 2007), are repealed.
3.          In these Determinations:
             “Act” means the National Health Act 1953;
             “base-priced drug” means —
(a)        in relation to ranitidine hydrochloride (tablet, effervescent, equivalent to 150 mg ranitidine or syrup equivalent to 150 mg ranitidine per 10 mL, 300 mL): cimetidine or famotidine or nizatidine or ranitidine hydrochloride (tablet equivalent to 150 mg ranitidine or tablet equivalent to 300 mg ranitidine); or
(b)        in relation to amlodipine besylate or lercanidipine hydrochloride or nifedipine (tablet 20 mg (controlled release)): 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 Second Schedule to these Determinations, 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.
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 specified in the column headed “Form” in the First or Second Schedule to these Determinations in relation to a drug or medicinal preparation referred to in subsection 85(2) of the Act the name of which is specified in that Schedule, those particulars refer to the form or forms of the drug or medicinal preparation that is or are allowable for the purposes of Part VII of the Act to the effect that the drug or medicinal preparation in that form or in each of those forms is a pharmaceutical benefit when prescribed by a medical practitioner.
4A.      For the purposes of subsection 85(3) of the Act, where a form is specified in the column headed “Form” in the Fourth Schedule to these Determinations, that particular refers to the form of a medicinal preparation, which is composed of one or more of the drugs or medicinal preparations specified in Schedule 4 to the Declaration under subsection 85(2) of the Act with or without the addition of one or more of the substances specified in Schedule 5 to that Declaration, that is allowable for the purposes of Part VII of the Act to the effect that the medicinal preparation in that form is a pharmaceutical benefit when prescribed by a medical practitioner.
5.          For the purposes of subsection 88(1A) of the Act, where the strength, type of unit, size of unit or other particulars of form are specified in the column headed “Form” in the Third Schedule to these Determinations in relation to a drug or medicinal preparation referred to in subsection 85(2) of the Act the name of which is specified in that Schedule, those particulars refer to the form or forms of the drug or medicinal preparation that is or are allowable for the purposes of Part VII of the Act to the effect that the drug or medicinal preparation in that form or in each of those forms is a pharmaceutical benefit referred to in subsection 88(1A) of the Act for the supply of which a participating dental practitioner is authorised to write a prescription.
6.          The purposes set out in the column headed “Purposes” in Part 2 of the First or Second Schedule to these Determinations are the only purposes for which a medical practitioner may prescribe the maximum quantities and numbers of repeats specified in that Part in relation to those pharmaceutical benefits specified in that same Part.
7.          The purposes set out in the column headed “Purposes” in Part 2 of the Third Schedule to these Determinations are the only purposes for which a participating dental practitioner may prescribe the maximum quantities specified in that Part in relation to those pharmaceutical benefits specified in that same Part.
8.          For the purposes of subsection 85A(2)(c) of the Act, the manner of administration, if any, set out in the column headed “Manner of administration” in relation to a pharmaceutical benefit, the name of which is specified in:                
(a)        the First or Second Schedule to these Determinations, is the only manner in which a medical practitioner may, in a prescription, direct the pharmaceutical benefit to be administered; or
(b)        the Third Schedule to these Determinations, 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)(a) of the Act, the maximum quantity or number of units of a pharmaceutical benefit that may, in one prescription, be directed to be supplied on any one occasion is:                
(a)        where the name of the pharmaceutical benefit is specified — 
(i)         in Part 1 of the First Schedule to these Determinations — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum quantity” in relation to the pharmaceutical benefit; or
(ii)        in Part 2 of the First Schedule to these Determinations and the 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 benefit; or
(iii)       in Part 1 of the Second Schedule to these Determinations — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum quantity” in relation to the pharmaceutical benefit; or
(iv)      in Part 2 of the Second Schedule to these Determinations and the 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 benefit; or
(v)       in Part 1 of the Third Schedule to these Determinations — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum quantity” in relation to the pharmaceutical benefit; or
(vi)      in Part 2 of the Third Schedule to these Determinations and the 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 benefit; or
(b)        in any other case — the quantity or number, if any, specified in the column headed “Maximum quantity” in the Fourth Schedule to these Determinations in relation to the form of the pharmaceutical benefit.
10.        For the purposes of subsection 85A(2)(b) 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 name of the pharmaceutical benefit is specified — 
(i)         in Part 1 of the First Schedule to these Determinations — 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 the First Schedule to these Determinations 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 the Second Schedule to these Determinations — 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 the Second Schedule to these Determinations 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 the Fourth Schedule to these Determinations in relation to the form of the pharmaceutical benefit.
11.        The following purposes are specified in relation to each pharmaceutical benefit the name of which is specified in Part 2 of the First or Second Schedule to these Determinations:
(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 subsubparagraph 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 the First Schedule 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 the First Schedule.
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 each pharmaceutical benefit the name of which is specified in Part 2 of the Third Schedule to these Determinations:
(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.
14.        For the purposes of subsection 85(6) of the Act, the name of the manufacturer or the names of manufacturers denoted in accordance with the following table by letters appearing in the column headed “Brand” in the First, Second or Third Schedule to these Determinations in relation to a drug or medicinal preparation the name of which is specified in that Schedule is or are the brand or brands under which the drug or medicinal preparation may be supplied under Part VII of the Act as a pharmaceutical benefit:

Letters
Manufacturer's Name
Letters
Manufacturer's Name

AB
Abbott Australasia Pty Ltd
AE
AFT Pharmaceuticals Pty Limited

AF
Alphapharm Pty Limited
AG
Allergan Australia Pty Ltd

AH
Altana Pharma Pty Ltd
AL
Alphapharm Medical A Division of Alphapharm Pty Limited

AN
Amgen Australia Pty Ltd
AP
AstraZeneca Pty Ltd

AQ
Alcon Laboratories (Australia) Pty Ltd
AS
Aspen Pharmacare Australia Pty Ltd

AV
Aventis Pharma Pty Limited
AW
Arrow Pharmaceuticals Pty Limited

AX
Sanofi Pasteur Pty Limited
BC
Bristol Laboratories A Division of Bristol-Myers Squibb Australia Pty Ltd

BD
Biogen Idec Australia Pty Ltd
BF
Bellwether Pharma Limited

BG
Biochemie Australia A Division of Sandoz Pty Ltd
BN
Bayer Australia Limited

BP
British Pharmaceuticals
BQ
Bristol-Myers Squibb Pharmaceuticals A Division of Bristol-Myers Squibb Australia Pty Ltd

BR
B. Braun Australia Pty Ltd
BU
Bausch & Lomb Surgical A Division of Bausch & Lomb (Australia) Pty Ltd

BX
Baxter Healthcare Pty Limited
BY
Boehringer Ingelheim Pty Limited

CF
CNS Pharma Pty Ltd
CH
Chem mart Pty Limited

CO
Chemists' Own Pty Ltd A member of Sigma Group of Companies
CR
Pharmacor Limited

CS
CSL Limited
CX
Contact Lens Centre Australia Pty Ltd

DB
Diabetes Association of Australia
DN
Digiland Pty Ltd

DR
DiaCare International Pty Ltd
DT
DermaTech Laboratories Pty Ltd

EO
Ego Pharmaceuticals Pty Ltd
EP
EpiPharm Pty Ltd

ES
EBOS Group Pty Ltd
EX
Essex Laboratories

FA
F.H. Faulding & Co. Limited
FB
Pierre Fabre Medicament Australia Pty Limited

FL
C. B. Fleet Co. (Aust.) Pty Ltd
FM
Fawns and McAllan Pty Ltd A member of Sigma Group of Companies

FP
Ferring Pharmaceuticals Pty Ltd
FR
Charles E. Frosst Division of Merck Sharp & Dohme (Australia) Pty Ltd

GC
GlaxoSmithKline Consumer Healthcare
GD
General Diabetes Services

GH
Goldshield Healthcare (Australia) Pty Ltd
GK
GlaxoSmithKline Australia Pty Ltd

GM
Genepharm Pty Ltd
GN
Genepharm Australasia Limited

GP
GP Laboratories A Division of Pfizer Pty Limited
GX
GenRx Pty Ltd

HA
Hamilton Laboratories Pty Ltd
HX
Hexal Australia Pty Ltd

IQ
Ioquin A Division of Alcon Laboratories (Australia) Pty Ltd
IT
InterPharma Pty Ltd

IZ
Intensive Care Products Pty Ltd
JC
Janssen-Cilag Pty Ltd

JT
Johnson & Johnson Pacific Pty Limited
KN
Knoll A Division of Abbott Australasia Pty Ltd

KR
Kenral Division of Pharmacia Australia Pty Limited
KY
Key Pharmaceuticals Pty Ltd

LB
Life Bioscience Pty Ltd
LF
Laboratoires Fournier S.A.

LM
Link Medical Products Pty Ltd
LN
Lennon Healthcare A Division of Aspen Pharmacare Australia Pty Ltd

LU
Lundbeck Australia Pty Ltd
LY
Eli Lilly Australia Pty Limited

MD
Macarthur Research Division of Roche Products Pty Ltd
ME
Menley & James Division of GlaxoSmithKline Australia Pty Ltd

MF
Mundipharma Pty Ltd
MK
Merck Sharp & Dohme (Australia) Pty Ltd

MM
3M Pharmaceuticals Australia Pty Ltd
MQ
Merck Pharmaceuticals

MS
Abbott Diagnostics Division (MediSense Products)
MX
Mayne Pharma Pty Ltd

NA
National Diagnostic Products
NE
Norgine Pty Limited

NF
FlexPen Products of Novo Nordisk Pharmaceuticals Pty Ltd
NI
InnoLet Products of Novo Nordisk Pharmaceuticals Pty Ltd

NL
NovoLet Products of Novo Nordisk Pharmaceuticals Pty Ltd
NM
Novartis Medicines A Division of Novartis Pharmaceuticals Australia Pty Ltd

NO
Novo Nordisk Pharmaceuticals Pty Ltd
NT
Nestlé Australia Ltd

NU
Nutricia Australia Pty Limited
NV
Novartis Pharmaceuticals Australia Pty Ltd

OA
Orphan Australia Pty Ltd
OR
Organon (Australia) Pty Limited

OZ
Medical Specialities Australia Pty Ltd
PC
Pfizer Consumer Healthcare Pty Ltd

PD
Parke Davis Pty Ltd
PE
Pacific EyeCare A Division of Allergan Australia Pty Ltd

PF
Pfizer Pty Limited
PH
Pharmacia Australia Pty Limited

PK
Pharmatel Fresenius Kabi Pty Ltd
PL
Pharmalab

PM
PMC Pharma A Division of AstraZeneca Pty Ltd
PP
Petrus Pharmaceuticals Pty Ltd

PU
Pharmacia & Upjohn Pty Limited
PX
Point of Care Diagnostics Australia Pty Ltd

RA
Ranbaxy Australia Pty Limited
RC
Reckitt Benckiser (Australia) Pty Limited

RD
Roche Diagnostics Australia Pty Ltd
RE
Real-RL Division of GlaxoSmithKline Australia Pty Ltd

RO
Roche Products Pty Ltd
SB
Scientific Hospital Supplies Australia Products

SC
Schering Pty Ltd Australian Subsidiary of Schering AG, Berlin
SE
Servier Laboratories (Aust.) Pty Ltd

SG
Serono Australia Pty Ltd
SH
Schering-Plough Pty Ltd

SI
Sigma Pharmaceuticals Pty Ltd
SJ
Sharpe Laboratories Pty Ltd

SM
Solvay Pharmaceuticals Division of Solvay Biosciences Pty Ltd
SN
Smith & Nephew Healthcare

SU
Sauter Laboratories (Aust.) Pty Ltd
SW
Sanofi-Synthelabo Australia Pty Limited

SY
Schering AG
SZ
Sandoz Pty Ltd

TM
Technipro Marketing Pty Ltd
TW
Terry White Chemists

UC
UCB Pharma A Division of UCB Australia Pty Ltd
VF
Vitaflo Australia Pty Ltd

VT
Valeant Pharmaceuticals Australasia Pty Ltd
WA
Winthrop Pharmaceuticals Division of Sanofi-Aventis Australia Pty Limited

WF
MedWatchDog Pty Limited
WT
Wyeth Consumer Healthcare Pty Ltd

WW
Wm R. Warner
WX
Wyeth Australia Pty Limited

WY
Wyeth Pharmaceuticals Division of Wyeth Australia Pty Limited
ZP
Spirit Pharmaceuticals Pty Ltd


Abciximab
I.V. injection 10 mg in 5 mL vial
Injection
3
..
LY

Acamprosate Calcium
Tablet 333 mg (enteric coated)
Oral
180
1
AF

Acarbose
Tablet 50 mg
Oral
90
5
BN

 
Tablet 100 mg
Oral
90
5
BN

Acetazolamide
Tablet 250 mg
Oral
100
3
SI

Acetylcysteine Sodium
Inhalation solution equivalent to 200 mg acetylcysteine per mL, 5 mL
Inhalation
30
3
BQ

Aciclovir
Tablet 200 mg
Oral
50
..
AF, GK, GM, GX, HX

 
Tablet 800 mg
Oral
35
..
AF, CR, GK, GM, GX, HX

 
Eye ointment 30 mg per g, 4.5 g
Application to the eye
1
..
GK

Acitretin
Capsule 10 mg
Oral
100
2
RO

 
Capsule 25 mg
Oral
100
2
RO

Adalimumab
Injection 40 mg in 0.8 mL pre-filled syringe
Injection
2
3
AB

Adrenaline
I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector
Injection
1
..
CS

 
I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector
Injection
1
..
CS

Adrenaline Acid Tartrate
Injection equivalent to adrenaline 1 in 1,000, 1 mL
Injection
5
1
AP

Albendazole
Tablet 200 mg
Oral
6
..
GK

 
Tablet 400 mg
Oral
60
2
GK

Alendronate Sodium
Tablet equivalent to 70 mg alendronic acid
Oral
4
5
AW, MK

 
Tablet equivalent to 40 mg alendronic acid
Oral
30
5
MK

Alendronate Sodium with Colecalciferol
Tablet equivalent to 70 mg alendronic acid with 70 micrograms colecalciferol
Oral
4
5
MK

"Alfaré"
Oral powder 400 g
Oral
8
5
NT

Allopurinol
Tablet 100 mg
Oral
200
2
AF, CH, FM, GX, HX, SI, TW

 
Tablet 300 mg
Oral
60
2
AF, CH, FM, GX, HX, SI, TW

Alprazolam
Tablet 250 micrograms
Oral
50
..
AF, AW, HX, PH

 
Tablet 500 micrograms
Oral
50
..
AF, AW, HX, PH

 
Tablet 1 mg
Oral
50
2
AF, AW, CH, GM, GX, HX, PH, TW

 
Tablet 2 mg
Oral
50
2
AF, AW, CH, GM, GX, HX, PH, TW

Aluminium Hydroxide - Dried with Magnesium Hydroxide
Tablet 200 mg-200 mg
Oral suspension 200 mg-200 mg per 5 mL, 500 mL
Oral
Oral
200
2
5
5
PC, WW
PC, WW

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

Amantadine Hydrochloride
Capsule 100 mg
Oral
100
5
NV

Amiloride Hydrochloride
Tablet 5 mg
Oral
100
1
AF

Aminoglutethimide
Tablet 250 mg
Oral
100
5
NV

Amiodarone Hydrochloride
Tablet 100 mg
Oral
30
5
AF, AW, GX, HX, SW

 
Tablet 200 mg
Oral
30
5
AF, AW, CH, GX, HX, SW, TW

Amisulpride
Tablet 100 mg
Oral
30
5
SW

 
Tablet 200 mg
Oral
60
5
SW

 
Tablet 400 mg
Oral
60
5
SW

 
Oral solution 100 mg per mL, 60 mL
Oral
2
5
SW

Amitriptyline Hydrochloride
Tablet 10 mg
Oral
50
2
AF

 
Tablet 25 mg
Oral
50
2
AF

 
Tablet 50 mg
Oral
50
2
AF

Amlodipine Besylate
Tablet equivalent to 5 mg amlodipine
Oral
30
5
PF

 
Tablet equivalent to 10 mg amlodipine
Oral
30
5
PF

Amlodipine Besylate with Atorvastatin Calcium
Tablet equivalent to 5 mg amlodipine with 10 mg atorvastatin
Oral
30
5
PF

 
Tablet equivalent to 5 mg amlodipine with 20 mg atorvastatin
Oral
30
5
PF

 
Tablet equivalent to 5 mg amlodipine with 40 mg atorvastatin
Oral
30
5
PF

 
Tablet equivalent to 5 mg amlodipine with 80 mg atorvastatin
Oral
30
5
PF

 
Tablet equivalent to 10 mg amlodipine with 10 mg atorvastatin
Oral
30
5
PF

 
Tablet equivalent to 10 mg amlodipine with 20 mg atorvastatin
Oral
30
5
PF

 
Tablet equivalent to 10 mg amlodipine with 40 mg atorvastatin
Oral
30
5
PF

 
Tablet equivalent to 10 mg amlodipine with 80 mg atorvastatin
Oral
30
5
PF

Amoxycillin Trihydrate
Tablet, chewable, equivalent to 250 mg amoxycillin
Oral
20
1
GK

 
Tablet equivalent to 1 g amoxycillin
Oral
14
1
BG, GK, SZ

 
Capsule equivalent to 250 mg amoxycillin
Oral
20
1
AF, CH, GK, GM, GX, HX, SI, TW

 
Capsule equivalent to 500 mg amoxycillin
Oral
20
1
AF, CH, CS, GK, GM, GX, HX, SI, TW

 
Sachet containing oral powder equivalent to 3 g amoxycillin
Oral
1
..
GK

Amoxycillin Trihydrate with Potassium Clavulanate
Tablet equivalent to 500 mg amoxycillin-125 mg clavulanic acid
Oral
10
1
AL, AW, GK, HX, ME, SZ

 
Tablet equivalent to 875 mg amoxycillin-125 mg clavulanic acid
Oral
10
1
AL, AW, CH, GK, GX, HX, ME, SZ, TW

Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP
Powder for oral suspension equivalent to 125 mg amoxycillin-31.25 mg clavulanic acid per 5 mL, 75 mL
Oral
1
1
AL, GK, HX, ME

 
Powder for oral suspension equivalent to 400 mg amoxycillin-57 mg clavulanic acid per 5 mL, 60 mL
Oral
1
1
AL, GK, HX, ME

Amoxycillin Trihydrate with Water - Purified BP
Powder for paediatric oral drops equivalent to 100 mg amoxycillin per mL, 20 mL
Oral
1
1
GK

 
Powder for oral suspension equivalent to 125 mg amoxycillin per 5 mL, 100 mL
Oral
1
1
AF, CH, GK, GM, GX, HX, TW

 
Powder for oral suspension equivalent to 250 mg amoxycillin per 5 mL, 100 mL
Oral
1
1
AF, CH, GK, GM, GX, HX, SI, TW

 
Powder for oral suspension equivalent to 500 mg amoxycillin per 5 mL, 100 mL
Oral
1
1
SZ

Amphotericin
Lozenge 10 mg
Oral
20
1
BQ

 
Powder for injection 50 mg
Injection
1
..
BQ

Ampicillin Sodium
Powder for injection equivalent to 500 mg ampicillin
Injection
5
1
GM, LN

 
Powder for injection equivalent to 1 g ampicillin
Injection
5
1
AS, GM, LN

Ampicillin Trihydrate
Capsule equivalent to 250 mg ampicillin
Oral
24
1
AF

 
Capsule equivalent to 500 mg ampicillin
Oral
24
..
AF

Anakinra
Injection 100 mg in 0.67 mL single use pre-filled syringe
Injection
28
3
AN

Anastrozole
Tablet 1 mg
Oral
30
5
AP

Anecortave Acetate
Suspension for injection 15 mg in 0.5 mL
Posterior juxtascleral injection
1
..
AQ

Apraclonidine Hydrochloride
Eye drops equivalent to 5 mg apraclonidine per mL, 10 mL
Application to the eye
1
2
AQ

Aprepitant
Pack containing 1 capsule 125 mg and 2 capsules 80 mg
Oral
1
..
MK

Aripiprazole
Tablet 10 mg
Oral
30
5
BQ

 
Tablet 15 mg
Oral
30
5
BQ

 
Tablet 20 mg
Oral
30
5
BQ

 
Tablet 30 mg
Oral
30
5
BQ

Aspirin
Tablet 100 mg
Oral
112
1
FA, MX

 
Tablet, dispersible, 300 mg
Oral
96
1
RC

Atenolol
Tablet 50 mg
Oral
30
5
AF, AP, CH, GM, GX, SI, SZ, TW

Atomoxetine Hydrochloride
Capsule equivalent to 10 mg atomoxetine
Oral
56
5
LY

 
Capsule equivalent to 18 mg atomoxetine
Oral
56
5
LY

 
Capsule equivalent to 25 mg atomoxetine
Oral
56
5
LY

 
Capsule equivalent to 40 mg atomoxetine
Oral
56
5
LY

 
Capsule equivalent to 60 mg atomoxetine
Oral
56
5
LY

Atorvastatin Calcium
Tablet equivalent to 10 mg atorvastatin
Oral
30
5
PF

 
Tablet equivalent to 20 mg atorvastatin
Oral
30
5
PF

 
Tablet equivalent to 40 mg atorvastatin
Oral
30
5
PF

 
Tablet equivalent to 80 mg atorvastatin
Oral
30
5
PF

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

Atropine Sulfate
Injection 600 micrograms in 1 mL ampoule
Injection
10
1
AP

 
Eye drops 10 mg per mL, 15 mL
Application to the eye
1
2
SI

Auranofin
Tablet 3 mg
Oral
60
5
GH

Azathioprine
Tablet 25 mg
Oral
100
2
GK, HX

 
Tablet 50 mg
Oral
100
2
AF, AW, GK, GM, GX, HX

Azithromycin Dihydrate
Tablet equivalent to 500 mg azithromycin
Oral
2
..
PF

Azithromycin Dihydrate with Water - Purified BP
Powder for oral suspension equivalent to 200 mg azithromycin per 5 mL, 15 mL
Oral
1
..
PF

Baclofen
Tablet 10 mg
Oral
100
5
AF, AW, CH, GM, GX, HX, NV, TW

 
Tablet 25 mg
Oral
100
5
AF, AW, CH, GM, GX, HX, NV, TW

Balsalazide Sodium
Capsule 750 mg
Oral
180
5
PK

"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 administration
3
1
SW

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

Beclomethasone Dipropionate
Pressurised inhalation 50 micrograms per dose, 200 doses (CFC-free formulation)
Inhalation by mouth
1
5
MM

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

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

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

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

 
Powder for injection 900 mg
Injection
1
..
AS

Benzhexol Hydrochloride
Tablet 2 mg
Oral
200
2
SI

 
Tablet 5 mg
Oral
200
1
SI

Benztropine Mesylate
Tablet 2 mg
Oral
60
2
PL

 
Injection 2 mg in 2 mL ampoule
Injection
5
..
MK

Benzydamine Hydrochloride
Mouth and throat rinse 22.5 mg per 15 mL, 500 mL
Oral application
1
1
MM

Benzylpenicillin Sodium
Powder for injection equivalent to 600 mg benzylpenicillin
Injection
10
1
CS

 
Powder for injection equivalent to 3 g benzylpenicillin
Injection
10
..
CS

Betamethasone Acetate with Betamethasone Sodium Phosphate
Injection 3 mg-3.9 mg in 1 mL ampoule
Injection
5
..
SH

Betamethasone Dipropionate
Cream equivalent to 500 micrograms betamethasone per g, 15 g
Application
1
1
EX, SH

 
Ointment equivalent to 500 micrograms betamethasone per g, 15 g
Application
1
1
EX, SH

Betamethasone Valerate
Cream equivalent to 200 micrograms betamethasone per g, 100 g
Application
2
..
EX, FM, SH, SI

 
Cream equivalent to 500 micrograms betamethasone per g, 15 g
Application
1
1
FM, SI

 
Ointment equivalent to 200 micrograms betamethasone per g, 100 g
Application
2
..
EX, SH

 
Ointment equivalent to 500 micrograms betamethasone per g, 15 g
Application
1
1
FM, SI

Betaxolol Hydrochloride
Eye drops, suspension, equivalent to 2.5 mg betaxolol per mL, 5 mL
Application to the eye
1
5
AQ

 
Eye drops, solution, equivalent to 5 mg betaxolol per mL, 5 mL
Application to the eye
1
5
AQ, IQ

Bethanechol Chloride
Tablet 10 mg
Oral
100
2
HA

Bicalutamide
Tablet 50 mg
Oral
28
5
AP

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

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

Biperiden Hydrochloride
Tablet 2 mg
Oral
200
2
AB

Bisacodyl
Tablet 5 mg
Oral
200
2
AE, AS

 
Suppositories 10 mg, 10
Rectal
3
5
BY, PP

 
Suppositories 10 mg, 12
Rectal
3
4
FL, PP

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

Bisoprolol Fumarate
Tablet 2.5 mg
Oral
28
5
AL

 
Tablet 5 mg
Oral
28
5
AL

 
Tablet 10 mg
Oral
28
5
AL

Bivalirudin Trifluoroacetate
Powder for I.V. injection equivalent to 250 mg bivalirudin, vial
Injection
1
..
CS

Bleomycin Sulfate with any determined brand of Sodium Chloride Injection
Powder for injection 15,000 I.U. (with required solvent)
Injection
10
..
BQ, MX, SI

Brimonidine Tartrate
Eye drops 2 mg per mL, 5 mL
Application to the eye
1
5
AG, PE

Brimonidine Tartrate with Timolol Maleate
Eye drops 2 mg brimonidine tartrate with timolol maleate equivalent to 5 mg timolol per mL, 5 mL
Application to the eye
1
5
AG

Brinzolamide
Eye drops 10 mg per mL, 5 mL
Application to the eye
1
5
AQ, IQ

Bromocriptine Mesylate
Tablet equivalent to 2.5 mg bromocriptine
Oral
30
..
AF, NV

 
Capsule equivalent to 5 mg bromocriptine
Oral
60
5
AF, NV

 
Capsule equivalent to 10 mg bromocriptine
Oral
100
5
AF, NV

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

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

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

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

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

Budesonide with Eformoterol Fumarate Dihydrate
Powder for oral inhalation in breath actuated device 100 micrograms-6 micrograms per dose, 120 doses
Inhalation by mouth
1
5
AP

 
Powder for oral inhalation in breath actuated device 200 micrograms-6 micrograms per dose, 120 doses
Inhalation by mouth
1
5
AP

 
Powder for oral inhalation in breath actuated devices 400 micrograms-12 micrograms per dose, 60 doses, 2
Inhalation by mouth
1
5
AP

Buprenorphine
Transdermal patch 5 mg
Transdermal
2
..
MF

 
Transdermal patch 10 mg
Transdermal
2
..
MF

 
Transdermal patch 20 mg
Transdermal
2
..
MF

Bupropion Hydrochloride
Tablet 150 mg (sustained release)
Oral
30
..
AF, GK, HX, RE

Busulfan
Tablet 2 mg
Oral
100
..
GK

Cabergoline
Tablet 500 micrograms
Oral
2
..
PH

 
Tablet 1 mg
Oral
30
5
PU

 
Tablet 2 mg
Oral
30
5
PU

 
Tablet 4 mg
Oral
30
5
PU

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

Calcipotriol Monohydrate
Cream equivalent to 50 micrograms calcipotriol per g, 30 g
Application
1
1
CS

Calcitriol
Capsule 0.25 microgram
Oral
100
3
AF, AL, AW, GM, GX, HX, RO

Calcium Carbonate
Tablet, chewable, 1.25 g (equivalent to 500 mg calcium)
Oral
120
1
MM

 
Tablet 1.5 g (equivalent to 600 mg calcium)
Oral
120
1
WT

Calcium Citrate
Tablet equivalent to 250 mg calcium
Oral
120
1
KY

Calcium Folinate
Tablet equivalent to 15 mg folinic acid
Oral
10
..
MX

 
Injection equivalent to 50 mg folinic acid in 5 mL
Injection
5
5
IT, MX, PF

 
Injection equivalent to 100 mg folinic acid in 10 mL
Injection
10
1
IT, PF

 
Injection equivalent to 300 mg folinic acid in 30 mL
Injection
4
1
MX

Candesartan Cilexetil
Tablet 4 mg
Oral
30
5
AP

 
Tablet 8 mg
Oral
30
5
AP

 
Tablet 16 mg
Oral
30
5
AP

 
Tablet 32 mg
Oral
30
5
AP

Candesartan Cilexetil with Hydrochlorothiazide
Tablet 16 mg-12.5 mg
Oral
30
5
AP

Capecitabine
Tablet 150 mg
Oral
60
2
RO

 
Tablet 500 mg
Oral
120
2
RO

"Caprilon"
Oral powder 420 g
Oral
8
5
SB

Captopril
Tablet 12.5 mg
Oral
90
5
AF, BQ, CH, FM, GM, GX, HX, TW

 
Tablet 25 mg
Oral
90
5
AF, BQ, CH, FM, GM, GX, HX, TW

 
Tablet 50 mg
Oral
90
5
AF, BQ, CH, FM, GM, GX, HX, TW

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

Carbamazepine
Tablet 100 mg
Oral
200
2
NV, SZ

 
Tablet 200 mg
Oral
200
2
AF, NV, SZ

 
Tablet 200 mg (controlled release)
Oral
200
2
NV

 
Tablet 400 mg (controlled release)
Oral
200
2
NV

 
Oral suspension 100 mg per 5 mL, 300 mL
Oral
1
5
NV

Carbimazole
Tablet 5 mg
Oral
200
2
RO

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

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

Carbomer 980
Ocular lubricating gel 2 mg per g, 10 g
Application to the eye
1
5
BU, NM, NV

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

Carboplatin
Solution for I.V. injection 50 mg in 5 mL
Injection
2
..
IT, MX, PU

 
Solution for I.V. injection 150 mg in 15 mL
Injection
6
..
IT, MX, PU

 
Solution for I.V. injection 450 mg in 45 mL
Injection
2
..
IT, MX, PU

Carmellose Sodium
Eye drops 5 mg per mL, 15 mL
Application to the eye
1
5
AG

 
Eye drops 10 mg per mL, 15 mL
Application to the eye
1
5
AG

 
Eye drops 2.5 mg per mL, single dose units 0.6 mL, 24
Application to the eye
4
5
CX

 
Eye drops 5 mg per mL, single dose units 0.4 mL, 30
Application to the eye
3
5
AG

 
Eye drops 10 mg per mL, single dose units 0.4 mL, 30
Application to the eye
3
5
AG

 
Ocular lubricating gel 10 mg per mL, single dose units 0.6 mL, 28
Application to the eye
3
5
CX

Carmustine
Implants 7.7 mg, 8
Intracranial
1
..
OA

Carvedilol
Tablet 3.125 mg
Oral
30
..
CH, GX, MD, RO, TW

 
Tablet 6.25 mg
Oral
60
5
CH, GX, MD, RO, TW

 
Tablet 12.5 mg
Oral
60
5
CH, GX, MD, RO, TW

 
Tablet 25 mg
Oral
60
5
CH, GX, MD, RO, TW

Cefaclor Monohydrate
Tablet (sustained release) equivalent to 375 mg cefaclor
Oral
10
1
AF, AS, CH, GM, GX, LN, RA, TW

Cefaclor Monohydrate with Water - Purified BP
Powder for oral suspension equivalent to 125 mg cefaclor per 5 mL, 100 mL
Oral
1
1
AF, AS, AW, CH, GX, TW

 
Powder for oral suspension equivalent to 250 mg cefaclor per  5 mL, 75 mL
Oral
1
1
AF, AS, AW, CH, GX, TW

Cefepime Hydrochloride with any determined brand of Sodium Chloride Injection
Powder for injection equivalent to 1 g cefepime (with required solvent)
Powder for injection equivalent to 2 g cefepime (with required solvent)
Injection
10
..
BQ

 
Injection
10
..
BQ

Cefotaxime Sodium
Powder for injection equivalent to 1 g cefotaxime
Injection
10
..
MX, SZ

 
Powder for injection equivalent to 2 g cefotaxime
Injection
10
..
MX, SZ

Ceftriaxone Sodium
Powder for injection equivalent to 500 mg ceftriaxone
Injection
1
..
IZ

 
Powder for injection equivalent to 1 g ceftriaxone
Injection
5
..
IZ, MX, RO, SZ

 
Powder for injection equivalent to 2 g ceftriaxone
Injection
5
..
IZ, MX, RO, SZ

Cefuroxime Axetil
Tablet equivalent to 250 mg cefuroxime
Oral
14
1
GK

Celecoxib
Capsule 100 mg
Oral
60
3
PH

 
Capsule 200 mg
Oral
30
3
PH

Cephalexin
Capsule 250 mg (anhydrous)
Oral
20
1
AF, AS, CH, GM, GX, HX, LN, RA, TW

 
Capsule 500 mg (anhydrous)
Oral
20
1
AF, AS, CH, GM, GX, HX, LN, RA, TW

Cephalexin with Water - Purified BP
Granules for oral suspension 125 mg per 5 mL, 100 mL
Oral
1
1
AF, AS, CH, GM, GX, LN, TW

 
Granules for oral suspension 250 mg per 5 mL, 100 mL
Oral
1
1
AF, AS, CH, GM, GX, LN, TW

Cephalothin Sodium
Powder for injection equivalent to 1 g cephalothin
Injection
10
1
AS, MX

Cephazolin Sodium
Powder for injection equivalent to 500 mg cephazolin
Injection
10
..
MX

 
Powder for injection equivalent to 1 g cephazolin
Injection
10
..
AS, MX, SZ

Chlorambucil
Tablet 2 mg
Oral
100
2
GK

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

 
Eye drops 5 mg per mL, 10 mL
Application to the eye
1
2
PF, SI

 
Eye ointment 10 mg per g, 4 g
Application to the eye
1
..
PF, SI

Chlorpromazine Hydrochloride
Tablet 10 mg
Tablet 25 mg
Oral
Oral
100
100
5
5
SW
SW

 
Tablet 100 mg
Oral
100
5
SW

 
Oral solution 25 mg per 5 mL, 100 mL
Oral
1
5
SW

 
Injection 50 mg in 2 mL ampoule
Injection
10
..
SW

Chlorthalidone
Tablet 25 mg
Oral
100
1
NV

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

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

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

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

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

Cimetidine
Tablet 200 mg
Oral
120
5
AF, GK

 
Tablet 400 mg
Oral
60
5
AF, GK, GX

 
Tablet 800 mg
Oral
30
5
AF, GX

Ciprofloxacin Hydrochloride
Tablet equivalent to 500 mg ciprofloxacin
Oral
14
..
AL, AW, BF, BG, BN, GM, GN, GX, HX

 
Tablet equivalent to 750 mg ciprofloxacin
Oral
14
..
AL, AW, BF, BN, GM, GN, GX, HX

 
Tablet equivalent to 250 mg ciprofloxacin
Oral
2
..
BN

 
Ear drops equivalent to 3 mg ciprofloxacin per mL, 5 mL
Application to the ear
1
1
AQ

 
Eye drops equivalent to 3 mg ciprofloxacin per mL, 5 mL
Application to the eye
2
..
AQ, IQ

Cisplatin
I.V. injection 10 mg in 10 mL
Injection
1
..
PU

 
I.V. injection 50 mg in 50 mL
Injection
1
..
MX, PU

 
I.V. injection 100 mg in 100 mL
Injection
1
..
IT, MX

Citalopram Hydrobromide
Tablet equivalent to 10 mg citalopram
Oral
28
5
AF

 
Tablet equivalent to 20 mg citalopram
Oral
28
5
AF, AW, CH, GM, GX, LU, RE, SZ, TW, WA

 
Tablet equivalent to 40 mg citalopram
Oral
28
5
AF, GX, SZ

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

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

Clarithromycin
Tablet 250 mg
Oral
14
1
AB, AF, AW, CH, GM, GX, HX, TW

Clindamycin Hydrochloride
Capsule equivalent to 150 mg clindamycin
Oral
25
..
KR, PH

Clomiphene Citrate
Tablet 50 mg
Oral
10
5
AW, GX, HX, SG, SW

Clomipramine Hydrochloride
Tablet 25 mg
Oral
50
2
AF, CH, GX, NV, TW

Clonazepam
Tablet 500 micrograms
Oral
200
2
AF, RO

 
Tablet 2 mg
Oral
200
2
AF, RO

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

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

Clonidine Hydrochloride
Tablet 100 micrograms
Oral
100
5
BY

 
Tablet 150 micrograms
Oral
100
5
BY

Clopidogrel Hydrogen Sulfate
Tablet equivalent to 75 mg clopidogrel
Oral
28
5
BQ, SW

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

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

Codeine Phosphate
Tablet 30 mg
Oral
20
..
FM

Codeine Phosphate with Paracetamol
Tablet 30 mg-500 mg
Oral
20
..
AL, AV, CO, FM, GK, SW

Colchicine
Tablet 500 micrograms
Oral
100
2
AS, LN

Colestipol Hydrochloride
Oral powder, sachets 5 g, 120
Oral
1
5
PH

Copper Sulfate
Tablets, diagnostic compound, 36
 
2
3
BN

Cortisone Acetate
Tablet 5 mg
Oral
50
4
AS

 
Tablet 25 mg
Oral
60
4
AS

Cyclophosphamide
Tablet 50 mg
Oral
50
2
PH

Cyclophosphamide with any determined brand of Sodium Chloride Injection 
Powder for injection 500 mg (anhydrous) (with required solvent)
Powder for injection 1 g (anhydrous) (with required solvent)
Injection
2
..
BX

 
Injection
1
..
BX

 
Powder for injection 2 g (anhydrous) (with required solvent)
Injection
1
..
BX

Cyclosporin
Capsule 10 mg
Oral
120
3
NV

 
Capsule 25 mg
Oral
60
3
HX, NV

 
Capsule 50 mg
Oral
60
3
HX, NV

 
Capsule 100 mg
Oral
60
3
HX, NV

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

Cyproheptadine Hydrochloride
Tablet 4 mg (anhydrous)
Oral
100
2
FR

Cyproterone Acetate
Tablet 50 mg
Oral
20
5
AF, GM, GX, HX, SC, SY

 
Tablet 100 mg
Oral
50
5
GM, GX, HX, SC, SY

Cytarabine
Injection 100 mg in 5 mL vial
Injection
10
1
PU

Dalteparin Sodium
Injection 2,500 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe
Injection
10
1
PH

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

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

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

Danazol
Capsule 100 mg
Oral
100
5
AF

 
Capsule 200 mg
Oral
100
5
AF

Dantrolene Sodium
Capsule 25 mg
Oral
100
2
PU

 
Capsule 50 mg
Oral
100
2
PU

Dapsone
Tablet 25 mg
Oral
100
1
LM

 
Tablet 100 mg
Oral
100
1
LM

Desmopressin Acetate
Intranasal solution 100 micrograms per mL, 2.5 mL dropper bottle
Nasal
5
5
FP

 
Tablet 200 micrograms
Oral
30
5
FP

 
Nasal spray (pump pack) 10 micrograms per actuation, 60 actuations, 6 mL
Nasal
1
5
FP

Dexamethasone
Tablet 500 micrograms
Oral
30
4
AS

 
Tablet 4 mg
Oral
30
4
AS

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

Dexamethasone Sodium Metasulfobenzoate with Framycetin Sulfate and Gramicidin
Ear drops 500 micrograms (dexamethasone)-5 mg-50 micrograms per mL, 8 mL
Application to the ear
1
2
AV, SW

Dexamethasone Sodium Phosphate
Injection equivalent to 4 mg dexamethasone phosphate in 1 mL ampoule
Injection
5
..
MX

 
Injection equivalent to 8 mg dexamethasone phosphate in 2 mL vial
Injection
5
1
MX

 
Injection equivalent to 120 mg dexamethasone phosphate in 5 mL vial
Injection
1
..
MX

Dexamphetamine Sulfate
Tablet 5 mg
Oral
100
5
SI

"Dialamine"
Oral powder 200 g
Oral
10
5
SB

Diazepam
Tablet 2 mg
Oral
50
..
AF, AW, RO, SU

 
Tablet 5 mg
Oral
50
..
AF, AW, GM, RO, SU

 
Injection 10 mg in 2 mL ampoule
Injection
5
..
MX

Diclofenac Sodium
Tablet 25 mg (enteric coated)
Oral
100
3
AF, AW, CH, GM, GX, HX, NV, TW

 
Tablet 50 mg (enteric coated)
Oral
50
3
AF, AW, CH, GM, GX, HX, NV, TW

 
Suppository 100 mg
Rectal
40
3
NV

Dicloxacillin Sodium
Capsule equivalent to 250 mg dicloxacillin
Oral
24
..
AF, BQ, SI

 
Capsule equivalent to 500 mg dicloxacillin
Oral
24
..
AF, BQ, SI

 
Powder for injection equivalent to 500 mg dicloxacillin
Injection
5
..
BQ

 
Powder for injection equivalent to 1 g dicloxacillin
Injection
5
1
BQ

"Digestelact"
Oral powder 900 g
Oral
3
1
SJ

Digoxin
Tablet 62.5 micrograms
Oral
200
1
FM, SI

 
Tablet 250 micrograms
Oral
100
1
FM, SI

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

Dihydroergotamine Mesylate
Injection 1 mg in 1 mL ampoule
Injection
5
..
NV

Diltiazem Hydrochloride
Tablet 60 mg
Oral
90
5
AF, AV, CH, GM, GX, HX, SW, TW

 
Capsule 180 mg (controlled delivery)
Oral
30
5
AV, CH, GM, GX, SW, TW

 
Capsule 240 mg (controlled delivery)
Oral
30
5
AV, CH, GM, GX, SW, TW

 
Capsule 360 mg (controlled delivery)
Oral
30
5
AV, SW

Diphenoxylate Hydrochloride with Atropine Sulfate
Tablet 2.5 mg-25 micrograms
Oral
20
..
KR, PH

Diphtheria and Tetanus Vaccine - Adsorbed
Injection 0.5 mL ampoule
Injection
3
..
CS

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

Dipivefrine Hydrochloride
Eye drops 1 mg per mL, 10 mL
Application to the eye
1
5
AG

Dipyridamole
Capsule 200 mg (sustained release)
Oral
60
5
BY

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

Disodium Etidronate
Tablet 200 mg
Oral
60
5
PU

Disodium Etidronate and Calcium Carbonate
Pack containing 28 tablets disodium etidronate 200 mg and 76 tablets calcium carbonate 1.25 g (equivalent to 500 mg calcium)
Oral
1
1
PU

Disodium Pamidronate
Concentrated injection 15 mg in 5 mL vial
Injection
4
..
MX

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

 
Concentrated injection 30 mg in 10 mL vial
Injection
2
..
MX

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

 
Concentrated injection 60 mg in 10 mL vial
Injection
1
..
MX

Disopyramide
Capsule 100 mg
Oral
100
5
SW

 
Capsule 150 mg
Oral
100
5
SW

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
..
SW

 
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
..
SW

Dolasetron Mesylate
Tablet 200 mg
Oral
2
..
SW

 
I.V. injection 100 mg in 5 mL ampoule
Injection
1
..
SW

Domperidone
Tablet 10 mg
Oral
25
..
JC

Donepezil Hydrochloride
Tablet 5 mg
Oral
28
5
PF

 
Tablet 10 mg
Oral
28
5
PF

Dorzolamide Hydrochloride
Eye drops equivalent to 20 mg dorzolamide per mL, 5 mL
Application to the eye
1
5
MK

Dorzolamide Hydrochloride with Timolol Maleate
Eye drops equivalent to 20 mg dorzolamide-5 mg timolol per mL, 5 mL
Application to the eye
1
5
MK

Dothiepin Hydrochloride
Capsule 25 mg
Oral
50
2
AB, AF

 
Tablet 75 mg
Oral
30
2
AB, AF

Doxepin Hydrochloride
Tablet equivalent to 50 mg doxepin
Oral
50
2
AF

 
Capsule equivalent to 10 mg doxepin
Oral
50
2
AF, PF

 
Capsule equivalent to 25 mg doxepin
Oral
50
2
AF, PF

Doxorubicin Hydrochloride
Solution for I.V. injection or intravesical administration 10 mg in 5 mL single dose vial
Injection or intravesical administration
4
..
IT, MX, PH

 
Solution for I.V. injection or intravesical administration 20 mg in 10 mL single dose vial
Injection or intravesical administration
4
..
PH

 
Solution for I.V. injection or intravesical administration 50 mg in 25 mL single dose vial
Injection or intravesical administration
3
..
IT, MX, PH

 
Solution for I.V. injection or intravesical administration 100 mg in 50 mL single dose vial
Injection or intravesical administration
1
..
IT

 
Solution for I.V. injection or intravesical administration 200 mg in 100 mL single dose vial
Injection or intravesical administration
1
..
IT

Doxorubicin Hydrochloride - Pegylated Liposomal
Suspension for I.V. infusion 20 mg in 10 mL vial
Injection
1
..
SH

 
Suspension for I.V. infusion 50 mg in 25 mL vial
Injection
1
..
SH

Doxycycline Hydrochloride
Tablet equivalent to 50 mg doxycycline
Oral
25
5
AF, GM, PF

 
Capsule equivalent to 50 mg doxycycline (containing enteric coated pellets)
Oral
25
5
FA, MX

 
Tablet equivalent to 100 mg doxycycline
Oral
7
1
AF, GM, PF, SI

 
Capsule equivalent to 100 mg doxycycline (containing enteric coated pellets)
Oral
7
1
FA, MX

Doxycycline Monohydrate
Tablet equivalent to 50 mg doxycycline
Oral
25
5
AW, CH, GX, SZ, TW

 
Tablet equivalent to 100 mg doxycycline
Oral
7
1
CH, GX, SZ, TW

Drotrecogin Alfa (activated)
Powder for I.V. infusion 5 mg, vial
Injection
1
..
LY

 
Powder for I.V. infusion 20 mg, vial
Injection
1
..
LY

"Duocal"
Oral powder 400 g
Oral
8
5
SB

Dydrogesterone
Tablet 10 mg
Oral
28
2
SM

"Easiphen"
Oral liquid 250 mL
Oral
90
5
SB

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

Eformoterol Fumarate Dihydrate
Capsule containing powder for oral inhalation 12 micrograms (for use in Foradile Aerolizer)
Inhalation by mouth
60
5
NV

 
Powder for oral inhalation in breath actuated device 6 micrograms per dose, 60 doses
Inhalation by mouth
1
5
AP

 
Powder for oral inhalation in breath actuated device 12 micrograms per dose, 60 doses
Inhalation by mouth
1
5
AP

"EleCare"
Oral powder 400 g
Oral
8
5
AB

Enalapril Maleate
Tablet 5 mg
Oral
30
5
AF, BF, CH, GM, GX, HX, MK, SI, TW, WA

 
Tablet 10 mg
Oral
30
5
AF, BF, CH, FR, GM, GX, HX, MK, SI, TW, WA

 
Tablet 20 mg
Oral
30
5
AF, BF, CH, FR, GM, GX, HX, MK, SI, TW, WA

Enalapril Maleate with Hydrochlorothiazide
Tablet 20 mg-6 mg
Oral
30
5
MK

"Energivit"
Oral powder 400 g
Oral
8
5
SB

Enoxaparin Sodium
Injection 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre-filled syringe
Injection
10
1
SW

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

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

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

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

Entacapone
Tablet 200 mg
Oral
200
4
NV

Epirubicin Hydrochloride
Solution for injection 10 mg in 5 mL
Injection or intravesical administration
4
..
IT, PH

 
Solution for injection 20 mg in 10 mL
Injection or intravesical administration
4
..
PH

 
Solution for injection 50 mg in 25 mL
Injection or intravesical administration
4
..
IT, MX, PH

 
Powder for injection 50 mg
Injection or intravesical administration
4
..
MX

 
Solution for injection 100 mg in 50 mL
Injection or intravesical administration
2
..
IT, MX

 
Solution for injection 200 mg in 100 mL
Injection or intravesical administration
1
..
IT

Eplerenone
Tablet 25 mg
Oral
30
5
PF

 
Tablet 50 mg
Oral
30
5
PF

Eprosartan Mesylate
Tablet equivalent to 400 mg eprosartan
Oral
56
5
SM

 
Tablet equivalent to 600 mg eprosartan
Oral
28
5
SM

Eprosartan Mesylate with Hydrochlorothiazide
Tablet equivalent to 600 mg eprosartan with 12.5 mg hydrochlorothiazide
Oral
28
5
SM

Eptifibatide Acetate
Solution for I.V. injection equivalent to 20 mg eptifibatide in 10 mL vial
Injection
2
..
SH

 
Solution for I.V. infusion equivalent to 75 mg eptifibatide in 100 mL vial
Injection
3
..
SH

Erythromycin
Capsule 250 mg (containing enteric coated pellets)
Oral
25
1
FA, MX

Erythromycin Ethyl Succinate
Tablet equivalent to 400 mg erythromycin
Oral
25
1
AB, AF

Erythromycin Ethyl Succinate with Water - Purified BP
Powder for oral liquid equivalent to 200 mg erythromycin per 5 mL, 100 mL
Oral
1
1
AB, AF

 
Powder for oral liquid equivalent to 400 mg erythromycin per 5 mL, 100 mL
Oral
1
1
AB, AF

Erythromycin Lactobionate
Powder for I.V. infusion equivalent to 1 g erythromycin, vial
Injection
5
..
AB

Escitalopram Oxalate
Tablet equivalent to 10 mg escitalopram
Oral
28
5
CF, LU

 
Tablet equivalent to 20 mg escitalopram
Oral
28
5
CF, LU

 
Oral solution equivalent to 10 mg escitalopram per mL, 28 mL
Oral
1
5
LU

Esomeprazole Magnesium Trihydrate
Tablet (enteric coated), equivalent to 20 mg esomeprazole
Oral
30
1
AP

 
Tablet (enteric coated), equivalent to 40 mg esomeprazole
Oral
30
1
AP

Esomeprazole Magnesium Trihydrate and Clarithromycin and Amoxycillin Trihydrate
Pack containing 14 tablets (enteric coated) esomeprazole magnesium trihydrate equivalent to 20 mg esomeprazole, 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin trihydrate equivalent to 500 mg amoxycillin
Oral
1
..
AP

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

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

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

Ethacrynic Acid
Tablet 25 mg
Oral
200
1
MK

Ethosuximide
Capsule 250 mg
Oral
200
2
PF

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

Etonogestrel
Subcutaneous implant 68 mg
Subcutaneous implantation
1
..
OR

Etoposide
Capsule 50 mg
Oral
20
..
BQ

 
Capsule 100 mg
Oral
10
..
BQ

 
Solution for I.V. infusion 100 mg in 5 mL vial
Injection
5
..
IT, MX

Etoposide Phosphate
Powder for I.V. infusion 113.6 mg, vial
Injection
5
..
BQ

 
Powder for I.V. infusion 1.136 g, vial
Injection
1
..
BQ

Everolimus
Tablet 0.25 mg
Oral
60
3
NV

 
Tablet 0.5 mg
Oral
60
3
NV

 
Tablet 0.75 mg
Oral
120
3
NV

Exemestane
Tablet 25 mg
Oral
30
5
PH

Ezetimibe
Tablet 10 mg
Oral
30
5
MK

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

 
Tablet 10 mg-80 mg
Oral
30
5
MK

Famciclovir
Tablet 125 mg
Oral
40
1
NV

 
Tablet 250 mg
Oral
21
..
NV

 
Tablet 500 mg
Oral
30
..
NV

Famotidine
Tablet 20 mg
Oral
60
5
AF, AW, CH, GM, GX, MK, SZ, TW

 
Tablet 40 mg
Oral
30
5
AF, AW, CH, GM, GX, MK, SZ, TW

Felodipine
Tablet 2.5 mg (extended release)
Oral
30
5
AL, AP

 
Tablet 5 mg (extended release)
Oral
30
5
AL, AP

 
Tablet 10 mg (extended release)
Oral
30
5
AL, AP

Fenofibrate
Tablet 48 mg
Oral
60
5
LF

 
Tablet 145 mg
Oral
30
5
LF

Fentanyl
Transdermal patch 2.1 mg
Transdermal
5
..
JC

 
Transdermal patch 4.2 mg
Transdermal
5
..
JC

 
Transdermal patch 8.4 mg
Transdermal
5
..
JC

 
Transdermal patch 12.6 mg
Transdermal
5
..
JC

 
Transdermal patch 16.8 mg
Transdermal
5
..
JC

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

Ferrous Sulfate
Oral liquid 30 mg per mL, 250 mL
Oral
1
2
AE

Flecainide Acetate
Tablet 50 mg
Oral
60
5
MM

 
Tablet 100 mg
Oral
60
5
AF, MM

Flucloxacillin Magnesium with Water - Purified BP
Powder for oral suspension equivalent to 125 mg flucloxacillin per 5 mL, 100 mL
Oral
1
..
GK

 
Powder for oral suspension equivalent to 250 mg flucloxacillin per 5 mL, 100 mL
Oral
1
..
CS, GK

Flucloxacillin Sodium
Capsule equivalent to 250 mg flucloxacillin
Oral
24
..
AF, CS, GK, SI

 
Capsule equivalent to 500 mg flucloxacillin
Oral
24
..
AF, CS, GK, SI

 
Powder for injection equivalent to 500 mg flucloxacillin
Injection
5
..
CS, GM

 
Powder for injection equivalent to 1 g flucloxacillin
Injection
5
1
AS, CS, GM, MX

Fluconazole
Capsule 50 mg
Oral
28
5
AF, AW, HX, MX, PF, RA

 
Capsule 100 mg
Oral
28
5
AF, HX, MX, PF, RA

 
Capsule 200 mg
Oral
28
5
AF, AW, HX, MX, PF, RA

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

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

Fludrocortisone Acetate
Tablet 100 micrograms
Oral
200
1
BQ

Fluorometholone
Eye drops 1 mg per mL, 5 mL
Application to the eye
1
5
AG, AQ

Fluorometholone Acetate
Eye drops 1 mg per mL, 5 mL
Application to the eye
1
2
AQ

Fluorouracil
Injection 500 mg in 10 mL
Injection
10
..
IT, MX

 
Injection 1000 mg in 20 mL
Injection
5
..
IT

Fluoxetine Hydrochloride
Tablet, dispersible, equivalent to 20 mg fluoxetine
Oral
28
5
AL, LY

 
Capsule equivalent to 20 mg fluoxetine
Oral
28
5
AF, AL, BF, CH, GM, GX, HX, LY, SI, TW

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

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

 
Oily I.M. injection 100 mg in 1 mL ampoule
Injection
5
..
LU

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

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

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

Flurbiprofen Sodium
Eye drops 300 micrograms per mL, single dose units 0.4 mL, 5
Application to the eye
1
..
AG

Flutamide
Tablet 250 mg
Oral
100
5
AF, SH

Fluticasone Propionate
Pressurised inhalation 50 micrograms per dose, 120 doses (CFC-free formulation)
Inhalation by mouth
1
5
GK

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

 
Pressurised inhalation 250 micrograms per dose, 120 doses (CFC-free formulation)
Inhalation by mouth
1
1
GK

 
Powder for oral inhalation in breath actuated device 100 micrograms per dose, 60 doses
Inhalation by mouth
1
5
GK

 
Powder for oral inhalation in breath actuated device 250 micrograms per dose, 60 doses
Inhalation by mouth
1
5
GK

 
Powder for oral inhalation in breath actuated device 500 micrograms per dose, 60 doses
Inhalation by mouth
1
1
GK

Fluticasone Propionate with Salmeterol Xinafoate
Pressurised inhalation 50 micrograms fluticasone propionate with salmeterol xinafoate equivalent to 25 micrograms salmeterol per dose, 120 doses (CFC-free formulation)
Inhalation by mouth
1
5
GK

 
Pressurised inhalation 125 micrograms fluticasone propionate with salmeterol xinafoate equivalent to 25 micrograms salmeterol per dose, 120 doses (CFC-free formulation)
Inhalation by mouth
1
5
GK

 
Pressurised inhalation 250 micrograms fluticasone propionate with salmeterol xinafoate equivalent to 25 micrograms salmeterol per dose, 120 doses (CFC-free formulation)
Inhalation by mouth
1
5
GK

 
Powder for oral inhalation in breath actuated device 100 micrograms fluticasone propionate with salmeterol xinafoate equivalent to 50 micrograms salmeterol per dose, 60 doses
Inhalation by mouth
1
5
GK

 
Powder for oral inhalation in breath actuated device 250 micrograms fluticasone propionate with salmeterol xinafoate equivalent to 50 micrograms salmeterol per dose, 60 doses
Inhalation by mouth
1
5
GK

 
Powder for oral inhalation in breath actuated device 500 micrograms fluticasone propionate with salmeterol xinafoate equivalent to 50 micrograms salmeterol per dose, 60 doses
Inhalation by mouth
1
5
GK

Fluvastatin Sodium
Capsule equivalent to 20 mg fluvastatin
Oral
28
5
NM, NV

 
Capsule equivalent to 40 mg fluvastatin
Oral
28
5
NM, NV

 
Tablet (prolonged release) equivalent to 80 mg fluvastatin
Oral
28
5
NV

Fluvoxamine Maleate
Tablet 50 mg
Oral
30
5
AL, AW, HX, SM

 
Tablet 100 mg
Oral
30
5
AF, AW, HX, SM

Folic Acid
Tablet 500 micrograms
Oral
200
..
AF

 
Tablet 5 mg
Oral
200
1
AF

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

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

 
Injection 300 I.U. in 0.5 mL multi-dose cartridge
Injection
3
5
SG

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

 
Injection 450 I.U. in 0.75 mL multi-dose cartridge
Injection
3
5
SG

 
Injection 900 I.U. in 1.5 mL multi-dose cartridge
Injection
2
5
SG

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

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

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

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

Fondaparinux Sodium
Injection 2.5 mg in 0.5 mL single dose pre-filled syringe
Injection
7
..
GK

Fosinopril Sodium
Tablet 10 mg
Oral
30
5
AF, AW, BQ, GX, SZ

 
Tablet 20 mg
Oral
30
5
AF, AW, BQ, GX, SZ

Fosinopril Sodium with Hydrochlorothiazide
Tablet 10 mg-12.5 mg
Oral
30
5
BQ

 
Tablet 20 mg-12.5 mg
Oral
30
5
BQ

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

Framycetin Sulfate
Eye or ear drops 5 mg per mL, 8 mL
Application to the eye or ear
1
2
SW

Frusemide
Tablet 20 mg
Oral
100
1
CH, FM, GM, GX, SW, TW

 
Tablet 40 mg
Oral
100
1
AF, CH, FM, GM, GX, HX, SW, TW

 
Tablet 500 mg
Oral
50
3
FM

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

 
Injection 20 mg in 2 mL
Injection
5
..
HX, SW

Gabapentin
Capsule 100 mg
Oral
100
5
AF, AW, MX, PF

 
Capsule 300 mg
Oral
100
5
AF, AL, AW, CR, GM, GX, HX, MX, PF

 
Capsule 400 mg
Oral
100
5
AF, AL, AW, CR, GM, GX, HX, MX, PF

 
Tablet 600 mg
Oral
100
5
PF

 
Tablet 800 mg
Oral
100
5
AF, AW, PF

Galantamine Hydrobromide
Capsule (prolonged release) equivalent to 8 mg galantamine
Oral
28
5
JC

 
Capsule (prolonged release) equivalent to 16 mg galantamine
Oral
28
5
JC

 
Capsule (prolonged release) equivalent to 24 mg galantamine
Oral
28
5
JC

Gefitinib
Tablet 250 mg
Oral
30
1
AP

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

Gemcitabine Hydrochloride
Powder for I.V. infusion equivalent to 200 mg gemcitabine
Injection
4
2
LY

 
Powder for I.V. infusion equivalent to 1 g gemcitabine
Injection
2
2
LY

Gemfibrozil
Tablet 600 mg
Oral
60
5
AF, CH, GM, GX, HX, PF, SI, TW

Gentamicin Sulfate
Injection equivalent to 80 mg gentamicin in 2 mL ampoule
Injection
10
1
MX, PU

 
Eye drops equivalent to 3 mg gentamicin per mL, 5 mL
Application to the eye
1
2
AG

Gestrinone
Capsule 2.5 mg
Oral
8
5
SW

Glatiramer Acetate
Injection 20 mg in 1 mL single dose pre-filled syringe
Injection
28
5
SW

Glibenclamide
Tablet 5 mg
Oral
100
5
AF, SW

Gliclazide
Tablet 30 mg (modified release)
Oral
100
5
RA, SE

 
Tablet 80 mg
Oral
100
5
AF, AW, CH, GX, HX, SE, TW

Glimepiride
Tablet 1 mg
Oral
30
5
AF, AV, AW, SW, SZ

 
Tablet 2 mg
Oral
30
5
AF, AV, AW, SW, SZ

 
Tablet 3 mg
Oral
30
5
AF, AV, AW, SW, SZ

 
Tablet 4 mg
Oral
30
5
AF, AV, AW, SW, SZ

Glipizide
Tablet 5 mg
Oral
100
5
AF, PH

Glucagon Hydrochloride
Injection set containing 1 mg (1 I.U.) and 1 mL solvent in disposable syringe
Injection
1
1
NO

Glucose
I.V. infusion 278 mmol (anhydrous) per L, 1 L
Injection
5
1
BX

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

 
Reagent strips, 50 (Keto-Diastix)
 
2
2
BN

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

 
Electrode strips, 50 (Advantage II)
 
2
5
RD

 
Electrode strips, 50 (Ascensia Elite)
 
2
5
BN

 
Electrode strips, 50 (Freestyle Papillon)
 
2
5
MS

 
Electrode strips, 50 (Glucoboy)
 
2
5
DB

 
Electrode strips, 50 (Glucocard 01 Sensor)
 
2
5
OZ

 
Electrode strips, 50 (GlucoCare)
 
2
5
OZ

 
Electrode strips, 50 (GlucoCare Super Sensor)
 
2
5
OZ

 
Electrode strips, 50 (GlucoMen Sensor)
 
2
5
GD

 
Electrode strips, 50 (MWD Pen Sensor Strips)
 
2
5
WF

 
Electrode strips, 50 (Omnitest EZ)
 
2
5
BR

 
Electrode strips, 50 (Omnitest Plus)
 
2
5
BR

 
Electrode strips, 50 (Touch-In Plus)
 
2
5
DN

 
Electrode strips, 50 (TrueTrack)
 
2
5
DR

 
Discs containing electrode sensors, 10 sensors per disc, 5
 
2
5
BN

 
Electrode strips, 100 (Optium glucose)
 
1
5
MS

 
Electrode strips, 100 (Precision Plus)
 
1
5
MS

 
Electrode strips, 100 (SofTact)
 
1
5
MS

 
Electrode strips, 100 (TrueSense)
 
1
5
MS

 
Reagent strips, 50 (Accu-Chek Active)
 
2
5
RD

 
Reagent strips, 50 (Accu-Chek Go)
 
2
5
RD

 
Reagent strips, 51 (Accu-Chek Integra)
 
2
5
RD

 
Reagent strips, 50 (Betachek)
 
2
5
NA

 
Reagent strips, 50 (Betachek G5)
 
2
5
NA

 
Reagent strips, 50 (CareSens)
 
2
5
LB

 
Reagent strips, 50 (Glucoflex-R)
 
2
5
NA

 
Reagent strips, 50 (Glucostix)
 
2
5
BN

 
Reagent strips, 50 (SensoCard)
 
2
5
PX

Glucose Indicator—Urine
Reagent strips, 50 (Clinistix)
 
2
2
BN

 
Reagent strips, 50 (Diastix)
 
2
2
BN

Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate
Oral rehydration salts 3.56 g-470 mg-300 mg-530 mg per sachet, 10
Oral
1
..
AS, CH, GM, SW, TW

Glycerol
Suppositories 700 mg, 12
Rectal
3
5
PP

 
Suppositories 1.4 g, 12
Rectal
3
5
PP

 
Suppositories 2.8 g, 12
Rectal
3
5
PP

Glyceryl Trinitrate
Tablets 600 micrograms, 100
Oral
1
5
FM, SI

 
Buccal/sublingual spray (pump pack) 400 micrograms per dose, 200 doses
Buccal/sublingual
1
5
SW

 
Transdermal patch 18 mg
Transdermal
30
5
MM

 
Transdermal patch 25 mg
Transdermal
30
5
NV

 
Transdermal patch 40 mg
Transdermal
30
5
SH

 
Transdermal patch 36 mg
Transdermal
30
5
MM

 
Transdermal patch 50 mg
Transdermal
30
5
NV

 
Transdermal patch 80 mg
Transdermal
30
5
SH

 
Transdermal patch 54 mg
Transdermal
30
5
MM

 
Transdermal patch 120 mg
Transdermal
30
5
SH

Goserelin Acetate
Subcutaneous implant equivalent to 3.6 mg goserelin in pre-filled injection syringe
Subcutaneous implantation
1
5
AP

 
Subcutaneous implant (long acting) equivalent to 10.8 mg goserelin in pre-filled injection syringe
Subcutaneous implantation
1
1
AP

Goserelin Acetate and Bicalutamide
Pack containing 1 subcutaneous implant equivalent to 3.6 mg goserelin in pre-filled injection syringe and 28 tablets bicalutamide 50 mg
Subcutaneous implantation (implant) and oral (tablets)
1
5
AP

 
Pack containing 1 subcutaneous implant equivalent to 10.8 mg goserelin in pre-filled injection syringe and 28 tablets bicalutamide 50 mg
Subcutaneous implantation (implant) and oral (tablets)
1
..
AP

 
Pack containing 1 subcutaneous implant equivalent to 10.8 mg goserelin in pre-filled injection syringe and 84 tablets bicalutamide 50 mg
Subcutaneous implantation (implant) and oral (tablets)
1
1
AP

Granisetron Hydrochloride
Tablet equivalent to 2 mg granisetron
Oral
2
..
MX

 
Concentrated injection equivalent to 3 mg granisetron in 3 mL ampoule
Injection
1
..
MX

Griseofulvin
Tablet 125 mg
Oral
100
2
SI

 
Tablet 500 mg
Oral
28
2
SI

Haloperidol
Tablet 500 micrograms
Oral
100
5
SI

 
Tablet 1.5 mg
Oral
100
5
SI

 
Tablet 5 mg
Oral
50
5
SI

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

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

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

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

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

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

Heparin Sodium
Injection 5,000 units in 0.2 mL ampoule
Injection
5
5
MX

 
Injection (preservative-free) 5,000 I.U. in 5 mL ampoule
Injection
50
5
PU

 
Injection 35,000 units in 35 mL vial
Injection
12
5
MX

Hexamine Hippurate
Tablet 1 g
Oral
100
5
MM

Homatropine Hydrobromide
Eye drops 20 mg per mL, 15 mL
Application to the eye
1
2
AQ

Hydralazine Hydrochloride
Tablet 25 mg
Oral
200
2
AF

 
Tablet 50 mg
Oral
200
2
AF

Hydrochlorothiazide
Tablet 25 mg
Oral
100
1
PL

Hydrochlorothiazide with Amiloride Hydrochloride
Tablet 50 mg-5 mg
Oral
100
1
AF, MK

Hydrochlorothiazide with Triamterene
Tablet 25 mg-50 mg
Oral
100
1
AF

Hydrocortisone
Tablet 4 mg
Oral
50
4
AF

 
Tablet 20 mg
Oral
60
4
AF

 
Cream 10 mg per g, 50 g
Application
1
1
EO

Hydrocortisone Acetate
Eye ointment 5 mg per g, 5 g
Application to the eye
1
..
SI

 
Eye ointment 10 mg per g, 5 g
Application to the eye
1
..
SI

 
Cream 10 mg per g, 30 g
Application
1
1
FM, SI

 
Cream 10 mg per g, 50 g
Application
1
1
DT, FM, SI

 
Ointment 10 mg per g, 30 g
Application
1
1
FM, SI

 
Ointment 10 mg per g, 50 g
Application
1
1
FM, SI

 
Rectal foam 90 mg per applicatorful, 14 applications, aerosol 21.1 g
Rectal
2
3
GC

Hydrocortisone Sodium Succinate
Injection equivalent to 100 mg hydrocortisone with 2 mL solvent
Injection
2
..
PH

 
Injection equivalent to 250 mg hydrocortisone with 2 mL solvent
Injection
1
..
PH

Hydromorphone Hydrochloride
Tablet 2 mg
Tablet 4 mg
Oral
Oral
20
20
..
..
AB
AB

 
Tablet 8 mg
Oral
20
..
AB

 
Oral liquid 1 mg per mL, 473 mL
Oral
1
..
AB

 
Injection 2 mg in 1 mL ampoule
Injection
5
..
AB

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

 
Injection 50 mg in 5 mL ampoule
Injection
5
..
AB

 
Injection 500 mg in 50 mL vial
Injection
1
..
AB

Hydroxocobalamin
Injection 1 mg in 1 mL ampoule
Injection
2
..
MX

 
Injection 1 mg in 1 mL
Injection
3
..
MX

Hydroxocobalamin Acetate
Injection equivalent to 1 mg hydroxocobalamin in 1 mL
Injection
5
..
MX

Hydroxychloroquine Sulfate
Tablet 200 mg
Oral
100
1
SW

Hydroxyurea
Capsule 500 mg
Oral
100
..
BQ

Hypromellose
Eye drops 3 mg per mL, 15 mL
Application to the eye
1
5
NM, NV

 
Eye drops 5 mg per mL, 15 mL
Application to the eye
1
5
AQ, SI

Hypromellose 2900 with Dextran 70
Eye drops 3 mg-1 mg per mL, single dose units 0.4 mL, 28
Application to the eye
3
5
AQ

Hypromellose 4500 with Dextran 70
Eye drops 3 mg-1 mg per mL, 15 mL
Application to the eye
1
5
AQ, IQ

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

Ibuprofen
Tablet 200 mg
Oral
100
3
AF

 
Tablet 400 mg
Oral
30
..
AB

Idarubicin Hydrochloride
Capsule 5 mg
Oral
3
..
PH

 
Capsule 10 mg
Oral
3
..
PH

 
Solution for I.V. injection 5 mg in 5 mL single use vial
Injection
3
..
PH

 
Solution for I.V. injection 10 mg in 10 mL single use vial
Injection
6
..
PH

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

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

Imipramine Hydrochloride
Tablet 10 mg
Oral
50
2
LN, NV

 
Tablet 25 mg
Oral
50
2
LN, NV

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

Indapamide Hemihydrate
Tablet 1.5 mg (sustained release)
Oral
90
1
SE

 
Tablet 2.5 mg
Oral
90
1
AF, CH, GM, GX, HX, SE, SI, TW

Indomethacin
Capsule 25 mg
Oral
100
3
AF, MK

 
Suppository 100 mg
Rectal
40
3
MK

Influenza Vaccine (Split Virion) - Inactivated
Injection containing 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
..
AX, CS, GK, SM

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
..
ES

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
..
ES

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
..
ES

Insulin Aspart
Injection (human analogue) 100 units per mL, 10 mL vial
Injection
5
2
NO

 
Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5
Injection
5
1
NF, NO

Insulin Aspart with Insulin Aspart Protamine Suspension
Injections (human analogue), cartridges, 30 units-70 units per mL, 3 mL, 5
Injection
5
1
NF, NO

Insulin Detemir
Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5
Injection
5
1
NF, NO

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

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

Insulin - Isophane
Injection (bovine) 100 units per mL, 10 mL vial
Injection
5
2
AS

 
Injection (human) 100 units per mL, 10 mL vial
Injection
5
2
LY, NO

 
Injections (human), cartridges, 100 units per mL, 3 mL, 5
Injection
5
1
LY, NI, NL, NO

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

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

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

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

Insulin - Neutral
Injection (bovine) 100 units per mL, 10 mL vial
Injection
5
2
AS

 
Injection (human) 100 units per mL, 10 mL vial
Injection
5
2
LY, NO

 
Injections (human), cartridges, 100 units per mL, 3 mL, 5
Injection
5
1
LY, NO

Insulin - Neutral with Insulin - Isophane
Injection (human) 30 units-70 units per mL, 10 mL vial
Injection
5
2
LY, NO

 
Injection (human) 50 units-50 units per mL, 10 mL vial
Injection
5
2
NO

 
Injections (human), cartridges, 20 units-80 units per mL, 3 mL, 5
Injection
5
1
NO

 
Injections (human), cartridges, 30 units-70 units per mL, 3 mL, 5
Injection
5
1
LY, NI, NO

 
Injections (human), cartridges, 50 units-50 units per mL, 3 mL, 5
Injection
5
1
NO

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

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

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

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

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

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

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

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

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

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

Ipratropium Bromide
Pressurised inhalation 21 micrograms per dose, 200 doses (CFC-free formulation)
Inhalation by mouth
2
5
BY

 
Nebuliser solution 250 micrograms (anhydrous) in 1 mL single dose units, 30
Inhalation
2
5
AF, AW, BY, CH, GM, GX, PU, TW

 
Nebuliser solution 500 micrograms (anhydrous) in 1 mL single dose units, 30
Inhalation
2
5
AF, AW, BY, CH, GM, GX, PU, TW

 
Nebuliser solution 250 micrograms (anhydrous) per mL, 20 mL
Inhalation
2
2
BY

Irbesartan
Tablet 75 mg
Oral
30
5
BQ, SW

 
Tablet 150 mg
Oral
30
5
BQ, SW

 
Tablet 300 mg
Oral
30
5
BQ, SW

Irbesartan with Hydrochlorothiazide
Tablet 150 mg-12.5 mg
Tablet 300 mg-12.5 mg
Oral
Oral
30
30
5
5
BQ, SW
BQ, SW

Irinotecan Hydrochloride Trihydrate
I.V. injection 40 mg in 2 mL vial
I.V. injection 100 mg in 5 mL vial
Injection
Injection
1
2
3
3
MX, PU
MX, PU

Iron Polymaltose Complex
Injection 100 mg (iron) in 2 mL ampoule
Injection
5
..
AS, SI

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

Isoniazid
Tablet 100 mg
Oral
100
2
FM

Isosorbide Dinitrate
Tablet 10 mg
Oral
200
2
AF, SI

 
Tablet 5 mg (sublingual)
Oral
200
2
SI

Isosorbide Mononitrate
Tablet 60 mg (sustained release)
Oral
30
5
AF, AP, CH, GM, GX, HX, PM, TW

 
Tablet 120 mg (sustained release)
Oral
30
5
AP, PM

Isotretinoin
Capsule 10 mg
Oral
60
3
GM, GX, RO

 
Capsule 20 mg
Oral
60
3
CH, GM, GX, HX, RO, TW

 
Capsule 40 mg
Oral
30
3
GM

Itraconazole
Capsule 100 mg
Oral
60
5
JC

Ivermectin
Tablet 3 mg
Oral
4
..
MK

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

Ketoconazole
Tablet 200 mg
Oral
10
..
JC

 
Cream 20 mg per g, 30 g
Application
1
2
JC

 
Shampoo 10 mg per g, 100 mL
Application
1
1
JC

 
Shampoo 20 mg per g, 60 mL
Application
1
1
JC

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

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

Ketoprofen
Capsule 200 mg (sustained release)
Oral
28
3
AV, SW

 
Suppository 100 mg
Rectal
40
3
SW

"Kindergen"
Oral powder 400 g
Oral
16
5
SB

Labetalol Hydrochloride
Tablet 100 mg
Oral
100
5
AF, SI

 
Tablet 200 mg
Oral
100
5
AF, SI

Lactulose
Solution BP 3.34 g per 5 mL, 500 mL
Oral
1
5
AF, AW, GM, GX, HX, SM

Lamotrigine
Tablet 5 mg
Oral
56
5
AF, AW, GK, HX, ME

 
Tablet 25 mg
Oral
56
5
AF, AW, GK, GM, GX, HX, ME, RA

 
Tablet 50 mg
Oral
56
5
AF, AW, GK, GM, GX, HX, ME, RA

 
Tablet 100 mg
Oral
56
5
AF, AW, GK, GM, GX, HX, ME, RA

 
Tablet 200 mg
Oral
56
5
AF, AW, GK, GM, GX, HX, ME, RA

Lansoprazole
Capsule 30 mg
Oral
30
1
WY

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

 
Capsule 15 mg
Oral
30
5
WY

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

Latanoprost with Timolol Maleate
Eye drops 50 micrograms latanoprost with timolol maleate equivalent to 5 mg timolol per mL, 2.5 mL
Application to the eye
1
5
PF

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

 
Tablet 10 mg
Oral
30
5
AV, SW

 
Tablet 20 mg
Oral
30
5
AV, SW

Lercanidipine Hydrochloride
Tablet 10 mg
Oral
30
5
SM

 
Tablet 20 mg
Oral
30
5
SM

Letrozole
Tablet 2.5 mg
Oral
30
5
NV

Leuprorelin Acetate
I.M. injection (modified release), powder for injection 7.5 mg with diluent in pre-filled dual-chamber syringe
Injection
1
5
AB

 
Suspension for subcutaneous injection (modified release), 7.5 mg injection set
Injection
1
5
MX

 
I.M. injection (modified release), powder for injection 22.5 mg with diluent in pre-filled dual-chamber syringe
Injection
1
1
AB

 
Suspension for subcutaneous injection (modified release), 22.5 mg injection set
Injection
1
1
MX

 
I.M. injection (modified release), powder for injection 30 mg with diluent in pre-filled dual-chamber syringe
Injection
1
1
AB

 
Suspension for subcutaneous injection (modified release), 30 mg injection set
Injection
1
1
MX

 
Suspension for subcutaneous injection (modified release), 45 mg injection set
Injection
1
..
MX

Levetiracetam
Tablet 250 mg
Oral
60
5
UC

 
Tablet 500 mg
Oral
60
5
UC

 
Tablet 1 g
Oral
60
5
UC

Levobunolol Hydrochloride
Eye drops 2.5 mg per mL, 5 mL
Application to the eye
1
5
AG

Levodopa with Benserazide Hydrochloride
Dispersible tablet 50 mg-12.5 mg (benserazide)
Oral
100
5
RO

 
Dispersible tablet 100 mg-25 mg (benserazide)
Oral
100
5
RO

 
Tablet 100 mg-25 mg (benserazide)
Oral
100
5
RO

 
Tablet 200 mg-50 mg (benserazide)
Oral
100
5
RO

 
Capsule 50 mg-12.5 mg (benserazide)
Oral
100
5
RO

 
Capsule 100 mg-25 mg (benserazide)
Oral
100
5
RO

 
Capsule 100 mg-25 mg (benserazide) (sustained release)
Oral
100
5
RO

 
Capsule 200 mg-50 mg (benserazide)
Oral
100
5
RO

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

 
Tablet 100 mg-25 mg (anhydrous)
Oral
100
5
AF, MK

 
Tablet 250 mg-25 mg (anhydrous)
Oral
100
5
HX, MK

Levodopa with Carbidopa and Entacapone
Tablet 50 mg-12.5 mg-200 mg
Tablet 100 mg-25 mg-200 mg
Oral
Oral
200
200
4
4
NV
NV

 
Tablet 150 mg-37.5 mg-200 mg
Oral
200
4
NV

Levonorgestrel
Tablets 30 micrograms, 28
Oral
4
2
SC, WY

 
Intrauterine drug delivery system 52 mg
Intrauterine
1
..
SC

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

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

 
Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets
Oral
4
2
SC, SY, WX, WY

 
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
SC, SY, WX, WY

Lignocaine Hydrochloride
Injection 100 mg in 5 mL
Injection
5
..
PF

 
Infusion 500 mg in 5 mL ampoule
Injection
10
..
AP

Lincomycin Hydrochloride
Injection equivalent to 600 mg lincomycin in 2 mL vial
Injection
5
..
PH

Liothyronine Sodium
Tablet 20 micrograms
Oral
100
2
SI

Lisinopril
Tablet 5 mg
Oral
30
5
AF, AP, AW, BF, CH, CR, GM, GX, HX, MK, TW

 
Tablet 10 mg
Oral
30
5
AF, AP, AW, BF, CH, CR, GM, GX, HX, MK, TW

 
Tablet 20 mg
Oral
30
5
AF, AP, AW, BF, CH, CR, GM, GX, HX, MK, TW

Lithium Carbonate
Tablet 250 mg
Oral
200
2
AS

 
Tablet 450 mg (slow release)
Oral
200
2
GK

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

Loperamide Hydrochloride
Capsule 2 mg
Oral
12
..
AS, JC

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

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

Lumiracoxib
Tablet 200 mg
Oral
30
3
NV

Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride
Sachets containing powder for oral solution 13.125 g-350.7 mg-178.5 mg-46.6 mg, 30
Oral
1
5
NE

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

Medroxyprogesterone Acetate
Tablet 500 mg
Tablet 100 mg
Oral
Oral
30
100
2
2
PH
PH

 
Tablet 200 mg
Oral
60
2
PH

 
Tablet 250 mg
Oral
60
2
PH

 
Tablet 5 mg
Oral
56
2
KR, PH

 
Tablet 10 mg
Oral
30
2
HX, KR, PH

 
Injection 50 mg in 1 mL vial
Injection
1
1
PH

 
Injection 150 mg in 1 mL vial
Injection
1
1
KR, PH

Mefenamic Acid
Capsule 250 mg
Oral
50
2
PD

Megestrol Acetate
Tablet 160 mg
Oral
30
2
BQ

Meloxicam
Tablet 7.5 mg
Oral
30
3
AW, BY

 
Tablet 15 mg
Oral
30
3
AW, BY

 
Capsule 7.5 mg
Oral
30
3
BY

 
Capsule 15 mg
Oral
30
3
BY

Melphalan
Tablet 2 mg
Oral
25
1
GK

Mercaptopurine
Tablet 50 mg
Oral
100
2
GK

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

 
Tablet 500 mg (enteric coated)
Oral
100
5
OA

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

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

 
Suppositories 1 g, 28
Rectal
1
..
FP

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

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

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

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

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

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

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

Metformin Hydrochloride
Tablet 500 mg
Oral
100
5
AF, AL, AW, BF, CH, CR, GM, GN, GX, HX, MQ, TW

 
Tablet 500 mg (extended release)
Oral
90
5
AL

 
Tablet 850 mg
Oral
60
5
AF, AL, AW, BF, CH, CR, GM, GN, GX, HX, MQ, TW

 
Tablet 1 g
Oral
90
5
AF, AL, AW

Metformin Hydrochloride with Glibenclamide
Tablet 250 mg-1.25 mg
Tablet 500 mg-2.5 mg
Oral
Oral
90
90
5
5
AL
AL

 
Tablet 500 mg-5 mg
Oral
90
5
AL

Methadone Hydrochloride
Tablet 10 mg
Oral
20
..
GK

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

Methotrexate
Tablet 2.5 mg
Oral
30
5
MX, PH

 
Tablet 10 mg
Oral
50
2
PH

 
Injection 5 mg in 2 mL vial
Injection
5
..
MX

 
Injection 50 mg in 2 mL vial
Injection
5
..
MX, PU

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

 
Solution concentrate for I.V. infusion 500 mg in 20 mL vial
Injection
1
..
MX

 
Solution concentrate for I.V. infusion 1000 mg in 10 mL vial
Injection
1
..
IT, MX

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

Methyldopa
Tablet 250 mg
Oral
100
5
AF, MK

Methylphenidate Hydrochloride
Tablet 10 mg
Oral
100
5
AF, NV

 
Tablet 18 mg (extended release)
Oral
30
5
JC

 
Tablet 36 mg (extended release)
Oral
30
5
JC

 
Tablet 54 mg (extended release)
Oral
30
5
JC

Methylprednisolone Aceponate
Cream 1 mg per g, 15 g
Ointment 1 mg per g, 15 g
Application
Application
1
1
..
..
CS
CS

 
Fatty ointment 1 mg per g, 15 g
Application
1
..
CS

 
Lotion 1 mg per g, 20 g
Application
1
..
CS

Methylprednisolone Acetate
Injection 40 mg in 1 mL vial
Injection
5
..
KR, PH

Methylprednisolone Sodium Succinate
Powder for injection equivalent to 40 mg methylprednisolone with diluent
Injection
5
..
PF

 
Powder for injection equivalent to 1 g methylprednisolone with diluent
Injection
1
..
PF

Methysergide Maleate
Tablet equivalent to 1 mg methysergide
Oral
100
2
NV

Metoclopramide Hydrochloride
Tablet 10 mg
Injection 10 mg in 2 mL ampoule
Oral
Injection
25
10
..
..
AF, VT
VT

Metoprolol Succinate
Pack containing 15 tablets 23.75 mg (controlled release), 15 tablets 47.5 mg (controlled release) and 15 tablets 95 mg (controlled release)
Oral
1
..
AP

 
Tablet 23.75 mg (controlled release)
Oral
15
..
AP

 
Tablet 47.5 mg (controlled release)
Oral
30
5
AP

 
Tablet 95 mg (controlled release)
Oral
30
5
AP

 
Tablet 190 mg (controlled release)
Oral
30
5
AP

Metoprolol Tartrate
Tablet 50 mg
Oral
100
5
AF, AP, AW, CH, GM, GX, HX, NV, TW

 
Tablet 100 mg
Oral
60
5
AF, AP, AW, CH, GM, GX, HX, NV, TW

Metronidazole
Tablet 200 mg
Oral
21
1
AF, AV, SW

 
Tablet 400 mg
Oral
5
2
AF

 
I.V. infusion 500 mg in 100 mL
Injection
5
1
BX

 
Suppositories 500 mg, 10
Rectal
1
..
SW

Metronidazole Benzoate
Oral suspension 320 mg per 5 mL, 100 mL
Oral
1
..
SW

Mexiletine Hydrochloride
Capsule 50 mg
Oral
100
5
BY

 
Capsule 200 mg
Oral
100
5
BY

Mianserin Hydrochloride
Tablet 10 mg
Oral
50
5
AF, OR

 
Tablet 20 mg
Oral
50
5
AF, OR

Miconazole
Tincture 20 mg per mL, 30 mL
Application
1
2
JC

Miconazole Nitrate
Cream 20 mg per g, 15 g
Application
2
3
JC

 
Cream 20 mg per g, 30 g
Application
1
2
JC

 
Cream 20 mg per g, 70 g
Application
1
1
JC

 
Powder 20 mg per g, 30 g
Application
1
2
JC

 
Lotion 20 mg per mL, 30 g
Application
1
2
JC

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

Minocycline Hydrochloride
Tablet equivalent to 50 mg minocycline
Oral
60
5
AF, SI

 
Capsule equivalent to 100 mg minocycline
Oral
11
..
AF

Minoxidil
Tablet 10 mg
Oral
100
5
PH

Mirtazapine
Tablet 15 mg (orally disintegrating)
Oral
30
5
BP

 
Tablet 30 mg
Oral
30
5
AF, AW, BP, GM, OR, SZ

 
Tablet 30 mg (orally disintegrating)
Oral
30
5
BP

 
Tablet 45 mg
Oral
30
5
AW, BP, SZ

 
Tablet 45 mg (orally disintegrating)
Oral
30
5
BP

Misoprostol
Tablet 200 micrograms
Oral
120
2
PH

Mitozantrone Hydrochloride
Injection equivalent to 10 mg mitozantrone in 5 mL
Injection
1
..
PU

 
Injection equivalent to 20 mg mitozantrone in 10 mL
Injection
1
..
BX, MX, PU

 
Injection equivalent to 25 mg mitozantrone in 12.5 mL
Injection
1
..
BX, PU

Moclobemide
Tablet 150 mg
Oral
60
5
AF, AL, CH, GM, GX, RO, SZ, TW

 
Tablet 300 mg
Oral
60
5
AF, AL, CH, GM, GX, RO, SI, SZ, TW

Modafinil
Tablet 100 mg
Oral
120
5
CS

Mometasone Furoate
Cream 1 mg per g, 15 g
Application
1
..
EX, SH

 
Ointment 1 mg per g, 15 g
Application
1
..
EX, SH

 
Lotion 1 mg per g, 30 mL
Application
1
..
EX, SH

"Monogen"
Oral powder 400 g
Oral
8
5
SB

Montelukast Sodium
Tablet, chewable, equivalent to 4 mg montelukast
Oral
28
5
MK

 
Tablet, chewable, equivalent to 5 mg montelukast
Oral
28
5
MK

Morphine Hydrochloride
Oral solution 2 mg per mL, 200 mL
Oral
1
..
MF

 
Oral solution 5 mg per mL, 200 mL
Oral
1
..
MF

 
Oral solution 10 mg per mL, 200 mL
Oral
1
..
MF

Morphine Sulfate
Tablet 10 mg
Oral
20
..
MF

 
Tablet 20 mg
Oral
20
..
MF

 
Tablet 30 mg
Oral
20
..
FM

 
Tablet 5 mg (controlled release)
Oral
20
..
MF

 
Tablet 10 mg (controlled release)
Oral
20
..
MF

 
Tablet 15 mg (controlled release)
Oral
20
..
MF

 
Tablet 30 mg (controlled release)
Oral
20
..
MF

 
Tablet 60 mg (controlled release)
Oral
20
..
MF

 
Tablet 100 mg (controlled release)
Oral
20
..
MF

 
Tablet 200 mg (controlled release)
Oral
20
..
MF

 
Capsule 10 mg (containing sustained release pellets)
Oral
20
..
GK

 
Capsule 20 mg (containing sustained release pellets)
Oral
20
..
GK

 
Capsule 30 mg (controlled release)
Oral
10
..
MF

 
Capsule 50 mg (containing sustained release pellets)
Oral
20
..
GK

 
Capsule 60 mg (controlled release)
Oral
10
..
MF

 
Capsule 90 mg (controlled release)
Oral
10
..
MF

 
Capsule 100 mg (containing sustained release pellets)
Oral
20
..
GK

 
Capsule 120 mg (controlled release)
Oral
10
..
MF

 
Sachet containing controlled release granules for oral suspension, 20 mg per sachet
Oral
20
..
MF

 
Sachet containing controlled release granules for oral suspension, 30 mg per sachet
Oral
20
..
MF

 
Sachet containing controlled release granules for oral suspension, 60 mg per sachet
Oral
20
..
MF

 
Sachet containing controlled release granules for oral suspension, 100 mg per sachet
Oral
20
..
MF

 
Sachet containing controlled release granules for oral suspension, 200 mg per sachet
Oral
20
..
MF

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

 
Injection 15 mg in 1 mL ampoule
Injection
5
..
MX

 
Injection 30 mg in 1 mL ampoule
Injection
5
..
MX

Morphine Tartrate
Injection 120 mg in 1.5 mL ampoule
Injection
5
..
MX

Moxonidine
Tablet 200 micrograms
Oral
30
5
SM

 
Tablet 400 micrograms
Oral
30
5
SM

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

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

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

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

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

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

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

Mycophenolate Mofetil
Capsule 250 mg
Oral
300
3
RO

 
Tablet 500 mg
Oral
150
3
RO

Mycophenolate Mofetil with Water - Purified BP
Powder for oral suspension 1 g per 5 mL, 165 mL
Oral
1
3
RO

Mycophenolate Sodium
Tablet (enteric coated) equivalent to 180 mg mycophenolic acid
Oral
120
3
NV

 
Tablet (enteric coated) equivalent to 360 mg mycophenolic acid
Oral
120
3
NV

Nafarelin Acetate
Nasal spray (pump pack) equivalent to 200 micrograms nafarelin per dose, 60 doses
Nasal
1
5
PH

Naloxone Hydrochloride
Injection 800 micrograms in 2 mL disposable injection set
Injection
1
..
CS

 
Injection 2 mg in 5 mL disposable injection set
Injection
1
..
CS

Naltrexone Hydrochloride
Tablet 50 mg
Oral
30
1
BQ

Nandrolone Decanoate
Injection 50 mg in 1 mL disposable syringe
Injection
1
7
OR

Naproxen
Tablet 250 mg
Oral
100
3
AF, RO

 
Tablet 500 mg
Oral
50
3
AF, RO

 
Tablet 750 mg (sustained release)
Oral
28
3
MD, RO

 
Tablet 1 g (sustained release)
Oral
28
3
MD, RO

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

Naproxen Sodium
Tablet 550 mg
Oral
50
3
MD, RO

Naratriptan Hydrochloride
Tablet equivalent to 2.5 mg naratriptan
Oral
4
5
GK

Nedocromil Sodium
Pressurised inhalation 2 mg per dose, 112 doses (CFC-free formulation)
Inhalation by mouth
1
5
SW

"Neocate"
Oral powder 400 g
Oral
8
5
SB

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

Neomycin Sulfate
Tablet 500 mg
Oral
25
1
AF

Neomycin Undecenoate with Bacitracin Zinc
Ear ointment 12 mg (3.5 mg neomycin)-400 units per g, 10 g
Application to the ear
1
..
HA

Nicorandil
Tablets 10 mg, 60
Oral
1
5
SW

 
Tablets 20 mg, 60
Oral
1
5
SW

Nifedipine
Tablet 10 mg
Oral
60
5
AF, AW, BN

 
Tablet 20 mg
Oral
60
5
AF, AW, BN, CH, GM, GX, HX, TW

 
Tablet 20 mg (controlled release)
Oral
30
5
BN

 
Tablet 30 mg (controlled release)
Oral
30
5
AF, AW, BN

 
Tablet 60 mg (controlled release)
Oral
30
5
AF, AW, BN

Nilutamide
Tablet 150 mg
Oral
30
5
SW

Nitrazepam
Tablet 5 mg
Oral
25
..
AF, VT

Nitrofurantoin
Capsule 50 mg
Oral
30
1
PU

 
Capsule 100 mg
Oral
30
1
PU

Nizatidine
Capsule 150 mg
Oral
60
5
AF, AS, LN

 
Capsule 300 mg
Oral
30
5
AF, AS, LN

Norethisterone
Tablets 350 micrograms, 28
Oral
4
2
JC, KR, PH

 
Tablet 5 mg
Oral
30
2
SC

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

 
Pack containing 21 tablets 500 micrograms-35 micrograms and 7 inert tablets
Oral
4
2
KR, PH

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

 
Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets
Oral
4
2
KR, PH

 
Pack containing 12 tablets 500 micrograms-35 micrograms, 9 tablets 1 mg-35 micrograms and 7 inert tablets
Oral
4
2
KR, PH

Norethisterone with Mestranol
Tablets 1 mg-50 micrograms, 21
Pack containing 21 tablets 1 mg-50 micrograms and 7 inert tablets
Oral
4
2
PH

 
Oral
4
2
PH

Norfloxacin
Tablet 400 mg
Oral
14
1
AF, AW, CH, GM, GX, HX, MK, TW

Nortriptyline Hydrochloride
Tablet equivalent to 10 mg nortriptyline
Oral
50
2
AS

 
Tablet equivalent to 25 mg nortriptyline
Oral
50
2
AS

Nystatin
Tablet 500,000 units
Oral
50
..
SI

 
Capsule 500,000 units
Oral
50
..
SI

 
Oral suspension 100,000 units per mL, 24 mL
Oral
1
1
BQ, SI

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

Oestradiol
Tablet 2 mg
Oral
56
2
SM

 
Transdermal patches 390 micrograms, 8
Transdermal
1
5
NV

 
Transdermal patches 2 mg, 4
Transdermal
1
5
MM, SC

 
Transdermal patches 2 mg, 8
Transdermal
1
5
NV

 
Transdermal patches 585 micrograms, 8
Transdermal
1
5
NV

 
Transdermal patches 3.28 mg, 8
Transdermal
1
5
NV

 
Transdermal patches 3.8 mg, 4
Transdermal
1
5
MM, SC

 
Transdermal patches 4 mg, 8
Transdermal
1
5
NV

 
Transdermal patches 780 micrograms, 8
Transdermal
1
5
NV

 
Transdermal patches 4.33 mg, 8
Transdermal
1
5
NV

 
Transdermal patches 5.7 mg, 4
Transdermal
1
5
SC

 
Transdermal patches 1.17 mg, 8
Transdermal
1
5
NV

 
Transdermal patches 6.57 mg, 8
Transdermal
1
5
NV

 
Transdermal patches 7.6 mg, 4
Transdermal
1
5
MM, SC

 
Transdermal patches 8 mg, 8
Transdermal
1
5
NV

 
Transdermal patches 1.56 mg, 8
Transdermal
1
5
NV

 
Transdermal patches 8.66 mg, 8
Transdermal
1
5
NV

 
Vaginal tablets 25 micrograms, 15
Vaginal
1
2
NO

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
SM

Oestradiol and Oestradiol with Norethisterone Acetate
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
NO

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

Oestradiol Hemihydrate
Nasal spray 150 micrograms per actuation, 60 actuations, 4.2 mL
Nasal
1
5
SE

 
Transdermal gel equivalent to 1 mg oestradiol in 1 g sachet, 28
Transdermal
1
5
OR

 
Transdermal patches equivalent to 750 micrograms oestradiol, 8
Transdermal
1
5
NV

 
Transdermal patches equivalent to 1.5 mg oestradiol, 8
Transdermal
1
5
NV

 
Transdermal patches equivalent to 3 mg oestradiol, 8
Transdermal
1
5
NV

Oestradiol Hemihydrate and Oestradiol Hemihydrate with Norethisterone Acetate
Pack containing 4 transdermal patches equivalent to 4.33 mg oestradiol and 4 transdermal patches equivalent to 620 micrograms oestradiol with 2.7 mg norethisterone acetate
Transdermal
1
5
NV

 
Pack containing 4 transdermal patches equivalent to 4.33 mg oestradiol and 4 transdermal patches equivalent to 510 micrograms oestradiol with 4.8 mg norethisterone acetate
Transdermal
1
5
NV

Oestradiol Hemihydrate with Norethisterone Acetate
Tablets equivalent to 1 mg oestradiol with 500 micrograms norethisterone acetate, 28
Oral
1
5
NO

 
Tablets equivalent to 2 mg oestradiol with 1 mg norethisterone acetate, 28
Oral
1
5
NO

 
Transdermal patches equivalent to 620 micrograms oestradiol with 2.7 mg norethisterone acetate, 8
Transdermal
1
5
NV

 
Transdermal patches equivalent to 510 micrograms oestradiol with 4.8 mg norethisterone acetate, 8
Transdermal
1
5
NV

Oestradiol Valerate
Tablet 1 mg
Oral
56
2
SC

 
Tablet 2 mg
Oral
56
2
SC

Oestriol
Pessaries 500 micrograms, 15
Vaginal
1
2
OR

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

Oestrogens—Conjugated
Tablet 300 micrograms
Oral
56
2
WY

 
Tablet 625 micrograms
Oral
56
2
WY

Oestrogens—Conjugated with Medroxyprogesterone Acetate
Tablets 625 micrograms-2.5 mg, 28
Tablets 625 micrograms-5 mg, 28
Oral
Oral
1
1
5
5
WY
WY

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

Olanzapine
Tablet 2.5 mg
Oral
28
5
LY

 
Tablet 5 mg
Oral
28
5
LY

 
Tablet 7.5 mg
Oral
28
5
LY

 
Tablet 10 mg
Oral
28
5
LY

 
Wafer 5 mg
Oral
28
5
LY

 
Wafer 10 mg
Oral
28
5
LY

Olmesartan Medoxomil
Tablet 20 mg
Oral
30
5
SH

 
Tablet 40 mg
Oral
30
5
SH

Olmesartan Medoxomil with Hydrochlorothiazide
Tablet 20 mg-12.5 mg
Tablet 40 mg-12.5 mg
Oral
Oral
30
30
5
5
SH
SH

 
Tablet 40 mg-25 mg
Oral
30
5
SH

Olsalazine Sodium
Capsule 250 mg
Oral
100
5
UC

 
Tablet 500 mg
Oral
100
5
UC

Omeprazole
Tablet 20 mg
Oral
30
1
HX, WA

 
Capsule 20 mg
Oral
30
1
SZ

Omeprazole and Clarithromycin and Amoxycillin Trihydrate
Pack containing 14 capsules omeprazole 20 mg, 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin trihydrate equivalent to 500 mg amoxycillin
Oral
1
..
AB

Omeprazole Magnesium
Tablet equivalent to 20 mg omeprazole
Oral
30
1
AL, AP, PM

 
Tablet equivalent to 10 mg omeprazole
Oral
30
5
AP

Ondansetron
Wafer 4 mg
Oral
4
..
GK, HX, RE

 
Wafer 8 mg
Oral
4
..
GK, HX, RE

Ondansetron Hydrochloride Dihydrate
Tablet equivalent to 4 mg ondansetron
Oral
4
..
AW, GK, HX, RE

 
Tablet equivalent to 8 mg ondansetron
Oral
4
..
AW, GK, HX, RE

 
Syrup equivalent to 4 mg ondansetron per 5 mL, 50 mL
Oral
1
1
GK

 
I.V. injection equivalent to 4 mg ondansetron in 2 mL ampoule
Injection
1
..
GK, HX, RE

 
I.V. injection equivalent to 8 mg ondansetron in 4 mL ampoule
Injection
1
..
GK, HX, RE

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

 
Powder for I.V. infusion 50 mg
Injection
1
2
IT, MX, WA, ZP

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

 
Powder for I.V. infusion 100 mg
Injection
1
2
IT, MX, WA, ZP

Oxazepam
Tablet 15 mg
Oral
25
..
AF, SI

 
Tablet 30 mg
Oral
25
..
AF, FM, SI

Oxcarbazepine
Tablet 150 mg
Oral
100
5
NV

 
Tablet 300 mg
Oral
100
5
NV

 
Tablet 600 mg
Oral
100
5
NV

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

Oxprenolol Hydrochloride
Tablet 20 mg
Oral
100
5
AF

 
Tablet 40 mg
Oral
100
5
AF

Oxybutynin Hydrochloride
Tablet 5 mg
Oral
100
5
SW

Oxycodone Hydrochloride
Tablet 5 mg
Oral
20
..
SI

 
Capsule 5 mg
Oral
20
..
MF

 
Capsule 10 mg
Oral
20
..
MF

 
Capsule 20 mg
Oral
20
..
MF

 
Oral solution 5 mg per 5 mL, 250 mL
Oral
1
..
MF

 
Tablet 5 mg (controlled release)
Oral
20
..
MF

 
Tablet 10 mg (controlled release)
Oral
20
..
MF

 
Tablet 20 mg (controlled release)
Oral
20
..
MF

 
Tablet 40 mg (controlled release)
Oral
20
..
MF

 
Tablet 80 mg (controlled release)
Oral
20
..
MF

Oxycodone Pectinate
Suppository equivalent to 30 mg oxycodone
Rectal
12
..
PL

Paclitaxel
Solution concentrate for I.V. infusion 30 mg in 5 mL vial
Injection
5
..
BQ, IT, MX

 
Solution concentrate for I.V. infusion 100 mg in 16.7 mL vial
Injection
2
..
BQ, IT, MX

 
Solution concentrate for I.V. infusion 150 mg in 25 mL vial
Injection
2
..
BQ, IT, MX

 
Solution concentrate for I.V. infusion 300 mg in 50 mL vial
Injection
1
..
BQ, IT, MX

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

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

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

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

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

Pantoprazole Sodium Sesquihydrate
Tablet (enteric coated), equivalent to 40 mg pantoprazole
Oral
30
2
AH

 
Tablet (enteric coated), equivalent to 20 mg pantoprazole
Oral
30
5
AH

Paracetamol
Tablet 500 mg
Oral
100
1
AW, CH, FM, GM, HX, JT, PC, SW, TW

 
Tablet 665 mg (modified release)
Oral
192
5
GC, ME

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

 
Oral liquid 240 mg per 5 mL, 200 mL
Oral
1
2
SW

Paraffin - Soft White with Paraffin - Liquid
Eye ointment, compound, 3.5 g
Application to the eye
2
5
AQ, IQ

 
Pack containing 2 tubes eye ointment, compound, 3.5 g
Application to the eye
1
5
AG, IQ, PE

Paroxetine Hydrochloride
Tablet equivalent to 20 mg paroxetine
Oral
30
5
AF, AW, CH, CR, GK, GM, GX, SZ, TW

Pemetrexed Disodium Heptahydrate
Powder for I.V. infusion equivalent to 500 mg pemetrexed, vial
Injection
2
2
LY

Penicillamine
Tablet 125 mg
Oral
100
1
AL

 
Tablet 250 mg
Oral
100
1
AL

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

Pergolide Mesylate
Tablet equivalent to 50 micrograms pergolide
Oral
100
..
AS

 
Tablet equivalent to 250 micrograms pergolide
Oral
100
5
AS

 
Tablet equivalent to 1 mg pergolide
Oral
100
5
AS

Perhexiline Maleate
Tablet 100 mg
Oral
100
5
SI

Pericyazine
Tablet 2.5 mg
Oral
100
5
SW

 
Tablet 10 mg
Oral
100
5
SW

Perindopril Arginine
Tablet 2.5 mg
Oral
30
5
SE

 
Tablet 5 mg
Oral
30
5
SE

 
Tablet 10 mg
Oral
30
5
SE

Perindopril Arginine with Indapamide Hemihydrate
Tablet 5 mg-1.25 mg
Oral
30
5
SE

Perindopril Erbumine
Tablet 2 mg
Oral
30
5
AF, CH, CR, GX, TW

 
Tablet 4 mg
Oral
30
5
AF, CH, CR, GX, TW

 
Tablet 8 mg
Oral
30
5
AF, CH, CR, GX, TW

Perindopril Erbumine with Indapamide Hemihydrate
Tablet 4 mg-1.25 mg
Oral
30
5
SE

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

Phenelzine Sulfate
Tablet equivalent to 15 mg phenelzine
Oral
100
1
LM

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

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

 
Oral powder 400 g
Oral
8
5
AB

Phenobarbitone
Tablet 30 mg
Oral
200
4
SI

Phenobarbitone Sodium
Injection 200 mg in 1 mL ampoule
Injection
5
..
FM

Phenoxybenzamine Hydrochloride
Capsule 10 mg
Oral
100
5
GH

Phenoxymethylpenicillin Benzathine
Oral suspension equivalent to 125 mg phenoxymethylpenicillin per 5 mL, 100 mL
Oral
2
..
FM, SI

 
Oral suspension equivalent to 250 mg phenoxymethylpenicillin per 5 mL, 100 mL
Oral
2
..
FM, SI

Phenoxymethylpenicillin Potassium
Tablet equivalent to 250 mg phenoxymethylpenicillin
Oral
50
..
SI

 
Tablet equivalent to 500 mg phenoxymethylpenicillin
Oral
50
..
SI

 
Capsule equivalent to 250 mg phenoxymethylpenicillin
Oral
50
..
CS, FM, GM, HX

 
Capsule equivalent to 500 mg phenoxymethylpenicillin
Oral
50
..
CS, FM, GM, HX

Phenytoin
Tablet 50 mg
Oral
200
2
PF

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

Phenytoin Sodium
Capsule 30 mg
Oral
200
2
PF

 
Capsule 100 mg
Oral
200
2
PF

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

 
Tablets 1 g, 75
Oral
24
5
SB

 
Bars 42 g, 20
Oral
10
5
SB

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

Pilocarpine Hydrochloride
Eye drops 5 mg per mL, 15 mL
Application to the eye
1
5
AG, PE

 
Eye drops 10 mg per mL, 15 mL
Application to the eye
1
5
AG, AQ, PE

 
Eye drops 20 mg per mL, 15 mL
Application to the eye
1
5
AG, AQ, PE

 
Eye drops 40 mg per mL, 15 mL
Application to the eye
1
5
AG, AQ, PE

 
Eye drops 60 mg per mL, 15 mL
Application to the eye
1
5
AG, PE

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

Pindolol
Tablet 5 mg
Oral
100
5
AF, NV

 
Tablet 15 mg
Oral
50
5
AF, NV

Pioglitazone Hydrochloride
Tablet equivalent to 15 mg pioglitazone
Oral
28
5
LY

 
Tablet equivalent to 30 mg pioglitazone
Oral
28
5
LY

 
Tablet equivalent to 45 mg pioglitazone
Oral
28
5
LY

Piperazine Oestrone Sulfate
Tablet 730 micrograms
Oral
56
2
KR, PH

 
Tablet 1.46 mg
Oral
56
2
KR, PH

Piroxicam
Dispersible tablet 10 mg
Oral
50
3
AF, GX, HX, PF

 
Dispersible tablet 20 mg
Oral
25
3
AF, CH, GX, HX, PF, TW

 
Capsule 10 mg
Oral
50
3
AF, CH, GX, PF, TW

 
Capsule 20 mg
Oral
25
3
AF, CH, GX, PF, TW

Pizotifen Malate
Tablet equivalent to 500 micrograms pizotifen
Oral
100
2
NV

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

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

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

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

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

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

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

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

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

Polyvinyl Alcohol
Eye drops 14 mg per mL, 15 mL
Application to the eye
1
5
AG, PE

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

 
Eye drops 30 mg per mL, 15 mL
Application to the eye
1
5
AG, PE

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

Potassium Chloride
Tablet 600 mg (sustained release)
Oral
200
1
AS, NM, NV

Potassium Chloride with Potassium Bicarbonate
Tablet, effervescent, 14 mmol K+ and 8 mmol Cl-
Oral
60
1
AS, LN

Pravastatin Sodium
Tablet 10 mg
Oral
30
5
AF, AW, BQ, CH, CR, GM, GX, RE, SZ, TW, WA

 
Tablet 20 mg
Oral
30
5
AF, AW, BQ, CH, CR, GM, GX, RE, SZ, TW, WA

 
Tablet 40 mg
Oral
30
5
AF, AW, BQ, CH, CR, GM, GX, RE, SZ, TW, WA

 
Tablet 80 mg
Oral
30
5
AW, BQ

Prazosin Hydrochloride
Tablet equivalent to 1 mg prazosin
Oral
100
5
AF, CH, GX, PF, TW

 
Tablet equivalent to 2 mg prazosin
Oral
100
5
AF, CH, GX, PF, TW

 
Tablet equivalent to 5 mg prazosin
Oral
100
5
AF, CH, GX, PF, TW

Prednisolone
Tablet 1 mg
Oral
100
4
AS, LN

 
Tablet 5 mg
Oral
60
4
AS, FM

 
Tablet 25 mg
Oral
30
4
AS, FM

Prednisolone Acetate with Phenylephrine Hydrochloride
Eye drops 10 mg-1.2 mg per mL, 10 mL
Application to the eye
1
2
AG

Prednisolone Sodium Phosphate
Oral solution equivalent to 5 mg prednisolone per mL, 30 mL
Oral
1
5
AS, LN

 
Enema, retention, equivalent to 20 mg prednisolone in 100 mL
Rectal
28
3
SI

 
Suppositories equivalent to 5 mg prednisolone, 10
Rectal
3
3
SI

Prednisone
Tablet 1 mg
Oral
100
4
AS, LN

 
Tablet 5 mg
Oral
60
4
AS, FM

 
Tablet 25 mg
Oral
30
4
AS, FM

Primidone
Tablet 250 mg
Oral
200
2
LM

Probenecid
Tablet 500 mg
Oral
100
5
PL

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

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

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

Prochlorperazine Maleate
Tablet 5 mg
Oral
25
..
AV, SW

Prochlorperazine Mesylate
Injection 12.5 mg in 1 mL ampoule
Injection
10
..
SW

Promethazine Hydrochloride
Injection 50 mg in 2 mL ampoule
Injection
10
..
MX

Propantheline Bromide
Tablet 15 mg
Oral
200
5
SI

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

Propranolol Hydrochloride
Tablet 10 mg
Oral
100
5
AF, AP

 
Tablet 40 mg
Oral
100
5
AF, AP

 
Tablet 160 mg
Oral
50
5
AF

Propylthiouracil
Tablet 50 mg
Oral
200
2
PL

Pyrantel Embonate
Tablet equivalent to 125 mg pyrantel
Oral
6
..
AF

 
Tablet equivalent to 250 mg pyrantel
Oral
6
..
AF

Pyridostigmine Bromide
Tablet 10 mg
Oral
100
5
VT

 
Tablet 60 mg
Oral
150
5
VT

 
Tablet 180 mg (modified release)
Oral
100
5
VT

Pyrimethamine
Tablet 25 mg
Oral
50
..
GK

Quetiapine Fumarate
Tablet equivalent to 25 mg quetiapine
Oral
60
5
AP

 
Tablet equivalent to 100 mg quetiapine
Oral
90
5
AP

 
Tablet equivalent to 200 mg quetiapine
Oral
60
5
AP

 
Tablet equivalent to 300 mg quetiapine
Oral
60
5
AP

Quinagolide Hydrochloride
Pack containing 3 tablets equivalent to 25 micrograms quinagolide and 3 tablets equivalent to 50 micrograms quinagolide
Oral
1
..
FP

 
Tablet equivalent to 75 micrograms quinagolide
Oral
30
5
FP

Quinapril Hydrochloride
Tablet equivalent to 5 mg quinapril
Oral
30
5
AF, AW, PF

 
Tablet equivalent to 10 mg quinapril
Oral
30
5
AF, AW, PF

 
Tablet equivalent to 20 mg quinapril
Oral
30
5
AF, AW, PF

Quinapril Hydrochloride with Hydrochlorothiazide
Tablet equivalent to 10 mg quinapril with 12.5 mg hydrochlorothiazide
Oral
30
5
PF

 
Tablet equivalent to 20 mg quinapril with 12.5 mg hydrochlorothiazide
Oral
30
5
PF

Quinine Bisulfate
Tablet 300 mg
Oral
50
2
AS

Quinine Sulfate
Tablet 300 mg
Oral
50
2
AS, LN

Rabeprazole Sodium
Tablet 20 mg (enteric coated)
Oral
30
2
JC

 
Tablet 10 mg (enteric coated)
Oral
28
5
JC

Raloxifene Hydrochloride
Tablet 60 mg
Oral
28
5
LY

Raltitrexed
Powder for I.V. infusion 2 mg in single use vial
Injection
3
2
AP

Ramipril
Tablet 1.25 mg
Oral
30
5
AV, AW, SW, SZ, WA

 
Tablet 2.5 mg
Oral
30
5
AV, AW, SW, SZ, WA

 
Tablet 5 mg
Oral
30
5
AV, AW, SW, SZ, WA

 
Capsule 10 mg
Oral
30
5
AV, AW, SW, SZ, WA

 
Pack containing 7 tablets 2.5 mg, 21 tablets 5 mg and 10 capsules 10 mg
Oral
1
..
SW

Ranitidine Hydrochloride
Tablet equivalent to 150 mg ranitidine
Oral
60
5
AF, CH, GK, GM, GX, HX, RA, SI, TW

 
Tablet, effervescent, equivalent to 150 mg ranitidine
Oral
60
5
GK

 
Tablet equivalent to 300 mg ranitidine
Oral
30
5
AF, CH, GK, GM, GX, HX, RA, SI, TW

 
Syrup equivalent to 150 mg ranitidine per 10 mL, 300 mL
Oral
2
5
GK

"RCF"
Oral liquid 384 mL
Oral
120
5
AB

Reboxetine Mesilate
Tablet equivalent to 4 mg reboxetine
Oral
60
5
PH

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
..
RO

Rifampicin
Capsule 150 mg
Oral
10
..
AF

 
Capsule 300 mg
Oral
10
..
AF

 
Syrup 100 mg per 5 mL, 60 mL
Oral
1
..
SW

Riluzole
Tablet 50 mg
Oral
56
5
SW

Risedronate Sodium
Tablet 5 mg
Oral
28
5
SW

 
Tablet 35 mg
Oral
4
5
SW

 
Tablet 30 mg
Oral
28
1
SW

Risedronate Sodium and Calcium Carbonate
Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium carbonate 1.25 g (equivalent to 500 mg calcium)
Oral
1
5
SW

Risperidone
Tablet 0.5 mg
Oral
60
2
JC

 
Tablet 0.5 mg (orally disintegrating)
Oral
56
2
JC

 
Tablet 1 mg
Oral
60
2
JC

 
Tablet 1 mg (orally disintegrating)
Oral
56
2
JC

 
Tablet 2 mg
Oral
60
2
JC

 
Tablet 2 mg (orally disintegrating)
Oral
56
2
JC

 
Tablet 3 mg
Oral
60
5
JC

 
Tablet 3 mg (orally disintegrating)
Oral
56
5
JC

 
Tablet 4 mg
Oral
60
5
JC

 
Tablet 4 mg (orally disintegrating)
Oral
56
5
JC

 
Oral solution 1 mg per mL, 30 mL
Oral
1
2
JC

 
Oral solution 1 mg per mL, 100 mL
Oral
1
5
JC

 
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
JC

 
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
JC

 
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
JC

Rituximab
Solution for I.V. infusion 100 mg in 10 mL vial
Injection
2
3
RO

 
Solution for I.V. infusion 500 mg in 50 mL vial
Injection
1
3
RO

Rivastigmine Hydrogen Tartrate
Capsule equivalent to 1.5 mg rivastigmine
Oral
56
5
NV

 
Capsule equivalent to 3 mg rivastigmine
Oral
56
5
NV

 
Capsule equivalent to 4.5 mg rivastigmine
Oral
56
5
NV

 
Capsule equivalent to 6 mg rivastigmine
Oral
56
5
NV

 
Oral solution equivalent to 2 mg rivastigmine per mL, 120 mL
Oral
1
5
NV

Rosiglitazone Maleate
Tablet equivalent to 4 mg rosiglitazone
Oral
28
5
GK

 
Tablet equivalent to 8 mg rosiglitazone
Oral
28
5
GK

Rosiglitazone Maleate with Metformin Hydrochloride
Tablet equivalent to 2 mg rosiglitazone with 500 mg metformin hydrochloride
Oral
56
5
GK

 
Tablet equivalent to 2 mg rosiglitazone with 1 g metformin hydrochloride
Oral
56
5
GK

 
Tablet equivalent to 4 mg rosiglitazone with 500 mg metformin hydrochloride
Oral
56
5
GK

 
Tablet equivalent to 4 mg rosiglitazone with 1 g metformin hydrochloride
Oral
56
5
GK

Rosuvastatin Calcium
Tablet equivalent to 5 mg rosuvastatin
Oral
30
5
AP

 
Tablet equivalent to 10 mg rosuvastatin
Oral
30
5
AP

 
Tablet equivalent to 20 mg rosuvastatin
Oral
30
5
AP

 
Tablet equivalent to 40 mg rosuvastatin
Oral
30
5
AP

Roxithromycin
Tablet for oral suspension 50 mg
Oral
10
1
SW

 
Tablet 150 mg
Oral
10
1
AF, AV, AW, RE, SW, SZ

 
Tablet 300 mg
Oral
5
1
AF, AV, AW, RE, SW, SZ

"S-26 LF"
Infant formula powder 900 g
Oral
5
..
WY

Salbutamol Sulfate
Oral solution equivalent to 2 mg salbutamol per 5 mL, 150 mL
Oral
2
5
GK

 
Capsule containing powder for oral inhalation equivalent to 200 micrograms salbutamol (for use in Ventolin Rotahaler)
Inhalation by mouth
200
5
GK

 
Pressurised inhalation equivalent to 100 micrograms salbutamol per dose, 200 doses (CFC-free formulation)
Inhalation by mouth
2
5
AL, AW, GK, MM

 
Pressurised inhalation in breath actuated device equivalent to 100 micrograms salbutamol per dose, 200 doses (CFC-free formulation)
Inhalation by mouth
2
5
MM

 
Nebuliser solution equivalent to 2.5 mg salbutamol in 2.5 mL single dose units, 30
Inhalation
2
5
AF, AW, CH, GK, GX, PU, TW

 
Nebuliser solution equivalent to 5 mg salbutamol in 2.5 mL single dose units, 30
Inhalation
2
5
AF, AW, CH, GK, GX, TW

 
Nebuliser solution equivalent to 5 mg salbutamol per mL, 30 mL
Inhalation
2
2
PU

Salcatonin
Injection 50 I.U. in 1 mL ampoule
Injection
30
5
NV

 
Injection 100 I.U. in 1 mL ampoule
Injection
15
5
NV

Salmeterol Xinafoate
Pressurised inhalation equivalent to 25 micrograms salmeterol per dose, 120 doses
Inhalation by mouth
1
5
GK

 
Powder for oral inhalation in breath actuated device equivalent to 50 micrograms salmeterol per dose, 60 doses
Inhalation by mouth
1
5
GK

Selegiline Hydrochloride
Tablet 5 mg
Oral
100
5
AF, GM

Sertraline Hydrochloride
Tablet equivalent to 50 mg sertraline
Oral
30
5
AF, AW, CH, CR, GM, GX, PF, RA, SZ, TW, WA

 
Tablet equivalent to 100 mg sertraline
Oral
30
5
AF, AW, CH, CR, GM, GX, PF, RA, SZ, TW, WA

Silver Sulfadiazine with Chlorhexidine Gluconate
Cream 10 mg-2 mg per g, 50 g
Cream 10 mg-2 mg per g, 100 g
Application
Application
1
1
..
..
SN
SN

Simvastatin
Tablet 5 mg
Oral
30
5
AF, BF, CR, FR, HX, MK, RE, WA

 
Tablet 10 mg
Oral
30
5
AF, AW, BF, CH, CR, FR, GM, GN, GX, HX, MK, RA, RE, TW, WA

 
Tablet 20 mg
Oral
30
5
AF, AW, BF, CH, CR, FR, GM, GN, GX, HX, MK, RA, RE, TW, WA

 
Tablet 40 mg
Oral
30
5
AF, AW, BF, CH, CR, FR, GM, GN, GX, HX, MK, RA, RE, TW, WA

 
Tablet 80 mg
Oral
30
5
AF, AW, BF, CH, CR, FR, GM, GN, GX, HX, MK, RA, RE, TW, WA

Sirolimus
Tablet 1 mg
Oral
100
3
WY

 
Tablet 2 mg
Oral
100
3
WY

 
Oral solution 1 mg per mL, 60 mL
Oral
1
3
WY

Sodium Acid Phosphate
Tablet, compound effervescent, equivalent to 500 mg phosphorus
Oral
100
5
NV

Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate
Oral liquid 1 g-320 mg-534 mg in 20 mL, 500 mL
Oral
2
5
RC

Sodium Aurothiomalate
Injection 10 mg ampoule
Injection
10
..
SW

 
Injection 20 mg ampoule
Injection
10
1
SW

 
Injection 50 mg ampoule
Injection
10
1
SW

Sodium Chloride
Injection 9 mg per mL, 10 mL
Injection
5
1
PF

 
I.V. infusion 154 mmol per L, 1 L
Injection
5
1
BX

 
I.V. infusion 513 mmol per L, 1 L
Injection
2
1
BX

Sodium Chloride with Glucose
I.V. infusion 31 mmol-222 mmol (anhydrous) per L, 1 L
Injection
5
1
BX

 
I.V. infusion 19 mmol-104 mmol (anhydrous) per 500 mL, 500 mL
Injection
5
1
BX

 
I.V. infusion 39 mmol-69 mmol (anhydrous) per 500 mL, 500 mL
Injection
5
1
BX

Sodium Chloride with Potassium Chloride and Calcium Chloride
I.V. infusion containing approximately 148 mmol Na+, 4 mmol K+, 2 mmol Ca2+ and 156 mmol Cl- per L, 1 L
Injection
4
1
BX

Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride
Electrolyte replacement solution 5.26 g-3.68 g-5.02 g- 370 mg-300 mg per L, 1 L
Injection
2
1
BX

Sodium Clodronate Tetrahydrate
Capsule equivalent to 400 mg sodium clodronate
Oral
100
2
SC

 
Tablet equivalent to 800 mg sodium clodronate
Oral
60
2
SC

Sodium Cromoglycate
Capsule containing powder for oral inhalation 20 mg (for use in Intal Spinhaler or Intal Halermatic)
Inhalation by mouth
100
5
GM

 
Pressurised inhalation 1 mg per dose, 200 doses
Inhalation by mouth
1
5
SW

 
Pressurised inhalation 1 mg per dose, 200 doses (CFC-free formulation)
Inhalation by mouth
1
5
SW

 
Pressurised inhalation 5 mg per dose, 112 doses (CFC-free formulation)
Inhalation by mouth
1
5
SW

 
Eye drops 20 mg per mL, 10 mL
Application to the eye
1
5
AE, SW

Sodium Fusidate
Tablet 250 mg
Oral
36
1
CS

Sodium Lactate with Sodium Chloride, Potassium Chloride and Calcium Chloride
I.V. infusion containing approximately 131 mmol Na+, 5 mmol K+, 2 mmol Ca2+, 29 mmol HCO3- (as lactate) and 111 mmol Cl- per L, 1 L
Injection
5
1
BX

Sodium Valproate
Tablet, crushable, 100 mg
Oral
200
2
SW

 
Tablet 200 mg (enteric coated)
Oral
200
2
AF, SW

 
Tablet 500 mg (enteric coated)
Oral
200
2
AF, SW

 
Oral liquid 200 mg per 5 mL, 300 mL
Oral
2
2
SW

 
Oral solution 200 mg per 5 mL, 300 mL
Oral
2
2
SW

Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate
Enemas 3.125 g-450 mg-45 mg in 5 mL, 12
Rectal
2
2
PH

Sotalol Hydrochloride
Tablet 80 mg
Oral
60
5
AW, BQ, GX, HX

 
Tablet 160 mg
Oral
60
5
AF, AW, BQ, CH, GM, GX, HX, TW

Spironolactone
Tablet 25 mg
Oral
100
5
AF, PH

 
Tablet 100 mg
Oral
100
5
AF, PH

Sterculia with Frangula Bark
Granules 620 mg-80 mg per g, 500 g
Oral
1
1
NE

Strontium Ranelate
Sachet containing granules for oral suspension 2 g
Oral
28
5
SE

Sucralfate
Tablet equivalent to 1 g anhydrous sucralfate
Oral
120
2
AF, AS

Sulfacetamide Sodium
Eye drops 100 mg per mL, 15 mL
Application to the eye
1
2
AG

Sulfasalazine
Tablet 500 mg
Oral
200
5
PH

 
Tablet 500 mg (enteric coated)
Oral
200
5
KR, PH

Sulindac
Tablet 100 mg
Oral
100
3
AF

 
Tablet 200 mg
Oral
50
3
AF

Sulthiame
Tablet 50 mg
Oral
200
2
PL

 
Tablet 200 mg
Oral
200
2
PL

Sumatriptan
Nasal spray 20 mg in 0.1 mL single dose unit
Nasal
2
5
GK

Sumatriptan Succinate
Tablet equivalent to 50 mg sumatriptan
Oral
4
5
AF, GK, ME

 
Tablet (fast disintegrating) equivalent to 50 mg sumatriptan
Oral
4
5
GK

Tacrolimus
Capsule 500 micrograms
Oral
100
3
JC

 
Capsule 1 mg
Oral
100
3
JC

 
Capsule 5 mg
Oral
50
3
JC

Tamoxifen Citrate
Tablet equivalent to 10 mg tamoxifen
Oral
60
5
AF, AP, GM

 
Tablet equivalent to 20 mg tamoxifen
Oral
60
5
AF, AP, CH, GM, GX, HX, SI, TW

Telmisartan
Tablet 40 mg
Oral
28
5
BY

 
Tablet 80 mg
Oral
28
5
BY

Telmisartan with Hydrochlorothiazide
Tablet 40 mg-12.5 mg
Tablet 80 mg-12.5 mg
Oral
Oral
28
28
5
5
BY
BY

Temazepam
Tablet 10 mg
Oral
25
..
AF, FM, SI

Temozolomide
Capsule 5 mg
Oral
15
2
SH

 
Capsule 20 mg
Oral
15
2
SH

 
Capsule 100 mg
Oral
15
2
SH

 
Capsule 250 mg
Oral
5
5
SH

Tenecteplase
Powder for injection 40 mg vial with solvent
Injection
1
..
BY

 
Powder for injection 50 mg vial with solvent
Injection
1
..
BY

Terbinafine Hydrochloride
Tablet equivalent to 250 mg terbinafine
Oral
42
1
AF, AW, CR, GM, GX, NV, SZ

Terbutaline Sulfate
Injection 500 micrograms in 1 mL ampoule
Injection
5
..
AP

 
Powder for oral inhalation in breath actuated device 500 micrograms per dose, 200 doses
Inhalation by mouth
1
5
AP

 
Nebuliser solution 5 mg in 2 mL single dose units, 30
Inhalation
2
5
AP

Testosterone
Subcutaneous implant 100 mg
Subcutaneous implantation
6
..
OR

 
Subcutaneous implant 200 mg
Subcutaneous implantation
3
..
OR

 
Transdermal gel 50 mg in 5 g sachet, 30
Transdermal
1
5
SC

 
Transdermal patches 12.2 mg, 60
Transdermal
1
5
MX

 
Transdermal patches 24.3 mg, 30
Transdermal
1
5
MX

Testosterone Enanthate
Injection 250 mg in 1 mL
Injection
3
3
SC

Testosterone Propionate with Testosterone Phenylpropionate, Testosterone Isocaproate and Testosterone Decanoate
Injection 30 mg-60 mg-60 mg-100 mg in 1 mL ampoule
Injection
3
3
OR

Testosterone Propionate with Testosterone Phenylpropionate and Testosterone Isocaproate
Injection 20 mg-40 mg-40 mg in 1 mL ampoule
Injection
3
3
OR

Testosterone Undecanoate
Capsule 40 mg
Oral
60
5
OR

 
I.M. injection 1,000 mg in 4 mL
Injection
1
1
SC

Tetrabenazine
Tablet 25 mg
Oral
112
5
OA

Tetracosactrin
Compound depot injection 1 mg in 1 mL ampoule
Injection
5
5
NV

Theophylline
Tablet 200 mg (sustained release)
Oral
100
5
MM

 
Tablet 250 mg (sustained release)
Oral
100
5
MM

 
Tablet 300 mg (sustained release)
Oral
100
5
MM

 
Oral solution 133.3 mg per 25 mL, 500 mL
Oral
1
5
MM

Thiamine Hydrochloride
Tablet 100 mg
Oral
100
2
SW

Thioguanine
Tablet 40 mg
Oral
25
1
GK

Thioridazine Hydrochloride
Tablet 10 mg
Oral
100
5
AF

 
Tablet 25 mg
Oral
100
5
AF

 
Tablet 50 mg
Oral
100
5
AF

 
Tablet 100 mg
Oral
100
5
AF

Thiotepa
Powder for injection 15 mg
Injection or intravesical administration
2
1
SI

Thyroxine Sodium
Tablet equivalent to 50 micrograms anhydrous thyroxine sodium
Oral
200
1
FM, SI

 
Tablet equivalent to 100 micrograms anhydrous thyroxine sodium
Oral
200
1
FM, SI

 
Tablet equivalent to 200 micrograms anhydrous thyroxine sodium
Oral
200
1
FM, SI

Tiagabine Hydrochloride
Tablet equivalent to 5 mg tiagabine
Oral
100
5
MX

 
Tablet equivalent to 10 mg tiagabine
Oral
100
5
MX

 
Tablet equivalent to 15 mg tiagabine
Oral
100
5
MX

Tiaprofenic Acid
Tablet 300 mg
Oral
60
3
SW

Ticarcillin Sodium with Potassium Clavulanate with any determined brand of Sodium Chloride Injection
Powder for injection equivalent to 3 g ticarcillin-100 mg clavulanic acid (with required solvent)
Injection
10
..
GK

Ticlopidine Hydrochloride
Tablet 250 mg
Oral
60
5
AF, HX, RO

Tiludronate Disodium
Tablet equivalent to 200 mg tiludronic acid
Oral
56
2
MX

Timolol Maleate
Eye gel equivalent to 1 mg timolol per g, 5 g
Application to the eye
1
5
NV

 
Eye drops equivalent to 2.5 mg timolol per mL, 5 mL
Application to the eye
1
5
FR, SI

 
Eye drops equivalent to 5 mg timolol per mL, 5 mL
Application to the eye
1
5
FR, SI

 
Eye drops (gellan gum solution) equivalent to 2.5 mg timolol per mL, 2.5 mL
Application to the eye
1
5
MK

 
Eye drops (gellan gum solution) equivalent to 5 mg timolol per mL, 2.5 mL
Application to the eye
1
5
MK

Tinidazole
Tablet 500 mg
Oral
4
..
GP, PF

Tiotropium Bromide Monohydrate
Capsule containing powder for oral inhalation equivalent to 18 micrograms tiotropium (for use in HandiHaler)
Inhalation by mouth
30
5
BY

Tirofiban Hydrochloride
Solution concentrate for I.V. infusion equivalent to 12.5 mg tirofiban in 50 mL vial
Injection
1
2
MK

Tobramycin
Eye drops 3 mg per mL, 5 mL
Application to the eye
1
2
AQ

 
Eye ointment 3 mg per g, 3.5 g
Application to the eye
1
..
AQ

Tobramycin Sulfate
Injection equivalent to 80 mg tobramycin in 2 mL
Injection
10
1
MX

 
Injection equivalent to 80 mg tobramycin in 2 mL (without preservative)
Injection
10
1
PU

Topiramate
Tablet 25 mg
Oral
60
5
JC

 
Tablet 50 mg
Oral
60
5
JC

 
Tablet 100 mg
Oral
60
5
JC

 
Tablet 200 mg
Oral
60
5
JC

 
Capsule 15 mg
Oral
60
5
JC

 
Capsule 25 mg
Oral
60
5
JC

 
Capsule 50 mg
Oral
60
5
JC

Topotecan Hydrochloride
Powder for I.V. infusion equivalent to 4 mg topotecan, vial
Injection
5
1
GK

Toremifene Citrate
Tablet equivalent to 60 mg toremifene
Oral
30
5
SH

Tramadol Hydrochloride
Capsule 50 mg
Oral
20
..
AF, AW, CH, CS, GX, TW

 
Tablet 50 mg (sustained release)
Oral
20
..
CS

 
Tablet 100 mg (sustained release)
Oral
20
..
AW, CS, HX

 
Tablet 150 mg (sustained release)
Oral
20
..
AW, CS, HX

 
Tablet 200 mg (sustained release)
Oral
20
..
AW, CS, HX

 
Oral drops 100 mg per mL, 10 mL
Oral
1
..
CS

 
Injection 100 mg in 2 mL ampoule
Injection
5
..
CS, HX

Trandolapril
Capsule 500 micrograms
Oral
28
5
AB, KN

 
Capsule 1 mg
Oral
28
5
AB, KN

 
Capsule 2 mg
Oral
28
5
AB, KN

 
Capsule 4 mg
Oral
28
5
AB

Trandolapril with Verapamil Hydrochloride
Tablet 4 mg-240 mg (sustained release)
Oral
28
5
AB

Tranexamic Acid
Tablet 500 mg
Oral
100
2
PH

Tranylcypromine Sulfate
Tablet equivalent to 10 mg tranylcypromine
Oral
50
2
GH

Travoprost
Eye drops 40 micrograms per mL, 2.5 mL
Application to the eye
1
5
AQ

Travoprost with Timolol Maleate
Eye drops 40 micrograms travoprost with timolol maleate equivalent to 5 mg timolol per mL, 2.5 mL
Application to the eye
1
5
AQ

Triamcinolone Acetonide
Injection 10 mg in 1 mL ampoule
Injection
5
..
BQ

 
Cream 200 micrograms per g, 100 g
Application
2
..
FM, SI

 
Ointment 200 micrograms per g, 100 g
Application
2
..
FM, SI

Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin
Ear drops 1 mg-2.5 mg (neomycin)-250 micrograms-100,000 units per g, 7.5 mL
Application to the ear
1
2
BC, BQ

 
Ear ointment 1 mg-2.5 mg (neomycin)-250 micrograms-100,000 units per g, 5 g
Application to the ear
1
2
BC, BQ

Trifluoperazine Hydrochloride
Tablet equivalent to 1 mg trifluoperazine
Oral
100
5
GH

 
Tablet equivalent to 2 mg trifluoperazine
Oral
100
5
GH

 
Tablet equivalent to 5 mg trifluoperazine
Oral
100
5
GH

Triglycerides Oil - Medium Chain
500 mL
Oral
2
5
SB

Trimethoprim
Tablet 300 mg
Oral
7
1
AF, SI

Trimethoprim with Sulfamethoxazole
Tablet 80 mg-400 mg
Tablet 160 mg-800 mg
Oral
Oral
10
10
1
1
AF, SI
AF, CH, GX, RO, SI, TW

 

 
Paediatric oral suspension 40 mg-200 mg per 5 mL, 100 mL
Oral
1
1
AF, RO, SI

Tropisetron Hydrochloride
Capsule equivalent to 5 mg tropisetron
Oral
2
..
NV

 
I.V. injection equivalent to 5 mg tropisetron in 5 mL ampoule
Injection
1
..
NV

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

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

Ursodeoxycholic Acid
Capsule 250 mg
Oral
100
2
OA

Valaciclovir Hydrochloride
Tablet equivalent to 500 mg valaciclovir
Oral
20
..
GK

Vancomycin Hydrochloride
Capsule equivalent to 125 mg (125,000 I.U.) vancomycin activity
Oral
40
..
AS

 
Capsule equivalent to 250 mg (250,000 I.U.) vancomycin activity
Oral
40
..
AS

 
Powder for injection equivalent to 500 mg (500,000 I.U.) vancomycin activity
Injection
2
..
AS, MX

Venlafaxine Hydrochloride
Capsule (modified release) equivalent to 37.5 mg venlafaxine
Oral
28
..
WY

 
Capsule (modified release) equivalent to 75 mg venlafaxine
Oral
28
5
WY

 
Capsule (modified release) equivalent to 150 mg venlafaxine
Oral
28
5
WY

Verapamil Hydrochloride
Tablet 40 mg
Oral
100
5
AB, AF

 
Tablet 80 mg
Oral
100
5
AB, AF

 
Tablet 120 mg
Oral
100
5
AB

 
Tablet 160 mg
Oral
60
5
AB

 
Tablet 180 mg (sustained release)
Oral
30
5
AB, KN

 
Tablet 240 mg (sustained release)
Oral
30
5
AB, AF, KN

 
Capsule 160 mg (sustained release)
Oral
30
5
SI

 
Capsule 240 mg (sustained release)
Oral
30
5
SI

 
Injection 5 mg in 2 mL ampoule
Injection
5
..
AB

Vigabatrin
Tablet 500 mg
Oral
100
5
SW

 
Oral powder, sachet 500 mg
Oral
60
5
SW

Vinblastine Sulfate
Solution for I.V. injection 10 mg in 10 mL vial
Injection
5
..
MX

Vincristine Sulfate
I.V. injection 1 mg in 1 mL vial
Injection
10
..
MX, PU

Vinorelbine Tartrate
Capsule equivalent to 20 mg vinorelbine
Oral
20
2
FB

 
Capsule equivalent to 30 mg vinorelbine
Oral
16
2
FB

 
Solution for I.V. infusion equivalent to 10 mg vinorelbine in 1 mL
Injection
16
2
FB, IT, MX

 
Solution for I.V. infusion equivalent to 50 mg vinorelbine in 5 mL
Injection
4
2
FB, IT, MX

Warfarin Sodium
Tablet 1 mg
Oral
50
2
FM, SI

 
Tablet 2 mg
Oral
50
2
SI

 
Tablet 3 mg
Oral
50
2
FM

 
Tablet 5 mg
Oral
50
2
FM, SI

"XLYS, LOW TRY Analog"
Oral powder 400 g
Oral
8
5
SB

"XLYS, LOW TRY Maxamaid"
Oral powder 500 g
Oral
8
5
SB

"XMET Analog"
Oral powder 400 g
Oral
8
5
SB

"XMET Maxamaid"
Oral powder 500 g
Oral
8
5
SB

"XMET Maxamum"
Oral powder 500 g
Oral
8
5
SB

"XMTVI Analog"
Oral powder 400 g
Oral
8
5
SB

"XMTVI Asadon"
Oral powder 200 g
Oral
5
5
SB

"XMTVI Maxamaid"
Oral powder 500 g
Oral
8
5
SB

"XMTVI Maxamum"
Oral powder 500 g
Oral
8
5
SB

"XP Analog"
Oral powder 400 g
Oral
8
5
SB

"XP Analog LCP"
Oral powder 400 g
Oral
8
5
SB

"XPhen, Tyr Analog"
Oral powder 400 g
Oral
8
5
SB

"XPhen, Tyr Maxamaid"
Oral powder 500 g
Oral
8
5
SB

"XPhen, Tyr Maxamum"
Oral powder 500 g
Oral
8
5
SB

"XP Maxamaid"
Oral powder 500 g
Oral
8
5
SB

"XP Maxamum"
Sachets containing oral powder 50 g, 30
Oral
3
5
SB

 
Oral powder 500 g
Oral
8
5
SB

"XPTM Tyrosidon"
Oral powder 500 g
Oral
4
5
SB

Ziprasidone Hydrochloride
Capsule equivalent to 20 mg ziprasidone
Oral
60
5
PF

 
Capsule equivalent to 40 mg ziprasidone
Oral
60
5
PF

 
Capsule equivalent to 60 mg ziprasidone
Oral
60
5
PF

 
Capsule equivalent to 80 mg ziprasidone
Oral
60
5
PF

Zolmitriptan
Tablet 2.5 mg
Oral
4
5
AP

Zuclopenthixol Decanoate
Oily I.M. injection 200 mg in 1 mL ampoule
Injection
5
..
LU


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
AF, CH, CR, GK, GM, GX, HX, RA, TW

 
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
AF, GK, GM, HX

Adalimumab
Injection 40 mg in 0.8 mL pre-filled syringe
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Commencement of adalimumab treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with adalimumab prior to 1 November 2004, who failed to qualify for PBS-subsidised therapy after 1 May 2004 due to an inability to receive concomitant methotrexate, and who have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab detailed below; and
Injection
2
5
AB

 
 
 
 where bDMARD means a drug included in the following list of drugs:
 
 
 
 

 
 
 
 adalimumab, anakinra, etanercept or infliximab; 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 authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;
 
 
 
 

 
 
 
 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
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Commencement of adalimumab treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with adalimumab prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 May 2004 due to testing negative for rheumatoid factor, and who have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab detailed below; and
 
 
 
 

 
 
 
 where bDMARD means a drug included in the following list of drugs:
 
 
 
 

 
 
 
 adalimumab, anakinra, etanercept or infliximab; 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 authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;
 
 
 
 

 
 
 
 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
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing treatment 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 with severe active rheumatoid arthritis, and:
 
 
 
 

 
 
 
 (a) who have demonstrated an adequate response to treatment with adalimumab; and
 
 
 
 

 
 
 
 (b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with adalimumab; and
 
 
 
 

 
 
 
 where bDMARD means a drug included in the following list of drugs:
 
 
 
 

 
 
 
 adalimumab, anakinra, etanercept or infliximab; 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 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;
 
 
 
 

 
 
 
 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;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Biological DMARD 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 an initial 16 week 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 treatment 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 severe active rheumatoid arthritis 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
AB

 
 
 
 (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
AB

 
 
 
 (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
AB

 
 
 
 (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
AB

 
 
 
 (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
..
CS

 
 
 
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
..
CS

 
 
 
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
GK

 
 
1525
 Treatment of tapeworm infestation
 
 
 
 

Amlodipine Besylate
Tablet equivalent to 5 mg amlodipine
 
In compliance with authority procedures set out in subparagraph 11 (d):
Adverse effects occurring with all of the base-priced drugs
Oral
30
5
PF

 
 
 
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 equivalent to 10 mg amlodipine
 
In compliance with authority procedures set out in subparagraph 11 (d):
Adverse effects occurring with all of the base-priced drugs
Oral
30
5
PF

 
 
 
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
 
 
 
 

Amoxycillin Trihydrate with Water - Purified BP
Powder for paediatric oral drops equivalent to 100 mg amoxycillin 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
GK

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):
Commencement of anakinra treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with anakinra prior to 1 July 2004 and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with anakinra detailed below; and
Injection
28
5
AN

 
 
 
 where bDMARD means a drug included in the following list of drugs:
 
 
 
 

 
 
 
 adalimumab, anakinra, etanercept or infliximab; 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;
 
 
 
 

 
 
 
 the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;
 
 
 
 

 
 
 
 the course of treatment is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Commencement of anakinra treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with anakinra prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 December 2004 due to testing negative for rheumatoid factor, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with anakinra detailed below; and
 
 
 
 

 
 
 
 where bDMARD means a drug included in the following list of drugs:
 
 
 
 

 
 
 
 adalimumab, anakinra, etanercept or infliximab; 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;
 
 
 
 

 
 
 
 the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;
 
 
 
 

 
 
 
 the course of treatment is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing treatment 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 with severe active rheumatoid arthritis, and:
 
 
 
 

 
 
 
 (a) who have demonstrated an adequate response to treatment with anakinra; and
 
 
 
 

 
 
 
 (b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with anakinra; and
 
 
 
 

 
 
 
 where bDMARD means a drug included in the following list of drugs:
 
 
 
 

 
 
 
 adalimumab, anakinra, etanercept or infliximab; 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 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;
 
 
 
 

 
 
 
 if this treatment cycle is the patient's first bDMARD treatment cycle and the patient has failed to demonstrate a response to PBS-subsidised treatment with adalimumab, etanercept and infliximab commenced prior to 1 December 2004, the patient is eligible to continue PBS-subsidised therapy with anakinra in this first treatment cycle, despite having previously failed to respond to 3 bDMARDs;
 
 
 
 

 
 
 
 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;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Biological DMARD 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 an initial 16 week 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 treatment 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 severe active rheumatoid arthritis who are receiving concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly 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 Dihydrate
Tablet equivalent to 500 mg azithromycin
 
Trachoma
Oral
2
2
PF

Benzathine Penicillin
Injection 900 mg in 2 mL cartridge-needle unit (for use with Tubex Injector)
 
Syphilis
Injection
2
..
AS

 
Powder for injection 900 mg
 
Syphilis
Injection
2
..
AS

Bromocriptine Mesylate
Tablet equivalent to 2.5 mg bromocriptine
 
Acromegaly
Parkinson's disease
Pathological hyperprolactinaemia where surgery is not indicated
Oral
60
5
AF, NV

 
 
 
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
..
MF

 
 
 
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
..
MF

 
 
 
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
..
MF

 
 
 
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 Hydrochloride
Tablet 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
..
AF, GK, HX, RE

Cabergoline
Tablet 500 micrograms
 
2659
In compliance with authority procedures set out in subparagraph 11 (d):
 Pathological hyperprolactinaemia where surgery is not indicated
Oral
8
5
PH

 
 
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 Sodium
Powder for injection equivalent to 500 mg ceftriaxone
 
Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
Septicaemia, suspected
Septicaemia, proven
Injection
5
..
IZ

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
OR

Ciprofloxacin Hydrochloride
Tablet equivalent to 250 mg ciprofloxacin
 
In compliance with authority procedures set out in subparagraph 11 (d):
Respiratory tract infection proven or suspected to be caused by Pseudomonas aeruginosa in severely immunocompromised patients
Bacterial gastroenteritis in severely immunocompromised patients
Oral
14
..
AL, AW, BG, BN, GX, HX

 
 
 
Treatment of infections proven to be due to Pseudomonas aeruginosa or other gram-negative bacteria resistant to all other oral antimicrobials
 
 
 
 

 
 
 
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 Phosphate with Paracetamol
Tablet 30 mg-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
..
AL, AV, CO, FM, GK, SW

Cyproterone Acetate
Tablet 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
AF, GM, GX, HX, SC, SY

Dalteparin Sodium
Injection 2,500 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe
 
Haemodialysis
Injection
20
3
PH

 
Injection 5,000 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe
 
Haemodialysis
Injection
20
3
PH

 
Injection 7,500 I.U. (anti-Xa) in 0.75 mL single dose pre-filled syringe
 
Haemodialysis
Injection
20
3
PH

Desmopressin Acetate
Tablet 200 micrograms
 
1678
In compliance with authority procedures set out in subparagraph 11 (d):
 Cranial diabetes insipidus
Oral
90
5
FP

 
Nasal spray (pump pack) 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
FP

Diazepam
Tablet 2 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Disabling spasticity
Oral
100
..
AF, AW, RO, SU

 
 
 
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
 
 
 
 

 
Tablet 5 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Disabling spasticity
Malignant neoplasia (late stage)
Oral
100
..
AF, AW, GM, RO, SU

 
 
 
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
 
 
 
 

"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
SJ

Doxycycline Hydrochloride
Tablet equivalent to 100 mg doxycycline
 
Pelvic inflammatory disease
Oral
28
..
AF, GM, PF, SI

 
Tablet equivalent to 100 mg doxycycline
 
Urethritis
Oral
21
..
AF, GM, PF, SI

 
Capsule equivalent to 100 mg doxycycline (containing enteric coated pellets)
 
Pelvic inflammatory disease
Oral
28
..
FA, MX

 
Capsule equivalent to 100 mg doxycycline (containing enteric coated pellets)
 
Urethritis
Oral
21
..
FA, MX

Doxycycline Monohydrate
Tablet equivalent to 100 mg doxycycline
 
Pelvic inflammatory disease
Oral
28
..
CH, GX, SZ, TW

 
Tablet equivalent to 100 mg doxycycline
 
Urethritis
Oral
21
..
CH, GX, SZ, TW

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
SG

 
 
 
 (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
AB

 
 
 
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 Sodium
Injection 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre-filled syringe
 
Haemodialysis
Injection
20
3
SW

 
Injection 40 mg (4,000 I.U. anti-Xa) in 0.4 mL pre-filled syringe
 
Haemodialysis
Injection
20
3
SW

 
Injection 60 mg (6,000 I.U. anti-Xa) in 0.6 mL pre-filled syringe
 
Haemodialysis
Injection
20
3
SW

Escitalopram Oxalate
Oral solution equivalent to 10 mg escitalopram 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
Major depressive disorders, where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
Oral
1
5
LU

 
 
 
 
 
 
 

 
 
 
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 Magnesium Trihydrate
Tablet (enteric coated), equivalent to 20 mg esomeprazole
 
Maintenance of healed gastro-oesophageal reflux disease
Oral
30
5
AP

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
WY

 
 
 
 (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
WY

 
 
 
 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
WY

 
 
 
 
 
 
 

 
 
 
 (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
WY

 
 
 
 (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 in 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 with severe active rheumatoid arthritis, and:
Injection
2
3
WY

 
 
 
 (a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or
 
 
 
 

 
 
 
 (ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and
 
 
 
 

 
 
 
 (b) who 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:
 
 
 
 

 
 
 
 (i) 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 that particular agent (or agents) only; or
 
 
 
 

 
 
 
 (ii) 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
 
 
 
 

 
 
 
 (c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD 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 bDMARD means a drug included in the following list of drugs:
 
 
 
 

 
 
 
 adalimumab, anakinra, etanercept or infliximab; 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 (b) 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;
 
 
 
 

 
 
 
 where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Biological DMARD 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 treatment 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 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 severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and
 
 
 
 

 
 
 
 where bDMARD means a drug included in the following list of drugs:
 
 
 
 

 
 
 
 adalimumab, anakinra, etanercept or infliximab; 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 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;
 
 
 
 

 
 
 
 patients are eligible to commence therapy with etanercept within this bDMARD 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, and provided they also meet the conditions applying to recommencement of etanercept therapy specified below, if applicable;
 
 
 
 

 
 
 
 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 if:
 
 
 
 

 
 
 
 (i) they have demonstrated an adequate response 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 when the most recent course of PBS-subsidised treatment was an initial 16 week course; and
 
 
 
 

 
 
 
 (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
 
 
 
 

 
 
 
 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 authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of etanercept therapy;
 
 
 
 

 
 
 
 a course of treatment 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, 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 severe active rheumatoid arthritis 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):
Commencement of etanercept treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with etanercept prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 August 2003 due to testing negative for rheumatoid factor, and who have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept detailed below; and
Injection
2
5
WY

 
 
 
 where bDMARD means a drug included in the following list of drugs:
 
 
 
 

 
 
 
 adalimumab, anakinra, etanercept or infliximab; 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 authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;
 
 
 
 

 
 
 
 the course of treatment is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing treatment 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 with severe active rheumatoid arthritis, and:
 
 
 
 

 
 
 
 (a) who have demonstrated an adequate response to treatment with etanercept; and
 
 
 
 

 
 
 
 (b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with etanercept; and
 
 
 
 

 
 
 
 where bDMARD means a drug included in the following list of drugs:
 
 
 
 

 
 
 
 adalimumab, anakinra, etanercept or infliximab; 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 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;
 
 
 
 

 
 
 
 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;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Biological DMARD 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 an initial 16 week 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 treatment 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 severe active rheumatoid arthritis 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
WY

 
 
 
 (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
WY

 
 
 
 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:
Injection
1
3
WY

 
 
 
 (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
 
 
 
 

 
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
WY

 
 
 
 (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 in 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 with severe active rheumatoid arthritis, and:
Injection
1
3
WY

 
 
 
 (a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or
 
 
 
 

 
 
 
 (ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and
 
 
 
 

 
 
 
 (b) who 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:
 
 
 
 

 
 
 
 (i) 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 that particular agent (or agents) only; or
 
 
 
 

 
 
 
 (ii) 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
 
 
 
 

 
 
 
 (c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD 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 bDMARD means a drug included in the following list of drugs:
 
 
 
 

 
 
 
 adalimumab, anakinra, etanercept or infliximab; 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 (b) 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;
 
 
 
 

 
 
 
 where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Biological DMARD 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 treatment 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 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 severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and
 
 
 
 

 
 
 
 where bDMARD means a drug included in the following list of drugs:
 
 
 
 

 
 
 
 adalimumab, anakinra, etanercept or infliximab; 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 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;
 
 
 
 

 
 
 
 patients are eligible to commence therapy with etanercept within this bDMARD 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, and provided they also meet the conditions applying to recommencement of etanercept therapy specified below, if applicable;
 
 
 
 

 
 
 
 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 if:
 
 
 
 

 
 
 
 (i) they have demonstrated an adequate response 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 when the most recent course of PBS-subsidised treatment was an initial 16 week course; and
 
 
 
 

 
 
 
 (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
 
 
 
 

 
 
 
 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 authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of etanercept therapy;
 
 
 
 

 
 
 
 a course of treatment 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, 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 severe active rheumatoid arthritis 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):
Commencement of etanercept treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with etanercept prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 August 2003 due to testing negative for rheumatoid factor, and who have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept detailed below; and
Injection
1
5
WY

 
 
 
 where bDMARD means a drug included in the following list of drugs:
 
 
 
 

 
 
 
 adalimumab, anakinra, etanercept or infliximab; 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 authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;
 
 
 
 

 
 
 
 the course of treatment is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing treatment 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 with severe active rheumatoid arthritis, and:
 
 
 
 

 
 
 
 (a) who have demonstrated an adequate response to treatment with etanercept; and
 
 
 
 

 
 
 
 (b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with etanercept; and
 
 
 
 

 
 
 
 where bDMARD means a drug included in the following list of drugs:
 
 
 
 

 
 
 
 adalimumab, anakinra, etanercept or infliximab; 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 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;
 
 
 
 

 
 
 
 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;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Biological DMARD 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 an initial 16 week 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 treatment 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 severe active rheumatoid arthritis 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
WY

 
 
 
 (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
WY

 
 
 
 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
WY

 
 
 
 (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
WY

 
 
 
 (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 in 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 with severe active rheumatoid arthritis, and:
Injection
1
3
WY

 
 
 
 (a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or
 
 
 
 

 
 
 
 (ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and
 
 
 
 

 
 
 
 (b) who 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:
 
 
 
 

 
 
 
 (i) 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 that particular agent (or agents) only; or
 
 
 
 

 
 
 
 (ii) 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
 
 
 
 

 
 
 
 (c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD 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 bDMARD means a drug included in the following list of drugs:
 
 
 
 

 
 
 
 adalimumab, anakinra, etanercept or infliximab; 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 (b) 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;
 
 
 
 

 
 
 
 where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Biological DMARD 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 treatment 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 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 severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and
 
 
 
 

 
 
 
 where bDMARD means a drug included in the following list of drugs:
 
 
 
 

 
 
 
 adalimumab, anakinra, etanercept or infliximab; 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 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;
 
 
 
 

 
 
 
 patients are eligible to commence therapy with etanercept within this bDMARD 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, and provided they also meet the conditions applying to recommencement of etanercept therapy specified below, if applicable;
 
 
 
 

 
 
 
 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 if:
 
 
 
 

 
 
 
 (i) they have demonstrated an adequate response 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 when the most recent course of PBS-subsidised treatment was an initial 16 week course; and
 
 
 
 

 
 
 
 (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment;
 
 
 
 

 
 
 
 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 authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of etanercept therapy;
 
 
 
 

 
 
 
 a course of treatment 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, 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 severe active rheumatoid arthritis 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):
Commencement of etanercept treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with etanercept prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 August 2003 due to testing negative for rheumatoid factor, and who have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept detailed below; and
Injection
1
5
WY

 
 
 
 where bDMARD means a drug included in the following list of drugs:
 
 
 
 

 
 
 
 adalimumab, anakinra, etanercept or infliximab; 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 authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient;
 
 
 
 

 
 
 
 the course of treatment is limited to a maximum of 24 weeks of treatment
 
 
 
 

 
 
 
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
 Continuing treatment 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 with severe active rheumatoid arthritis, and:
 
 
 
 

 
 
 
 (a) who have demonstrated an adequate response to treatment with etanercept; and
 
 
 
 

 
 
 
 (b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with etanercept; and
 
 
 
 

 
 
 
 where bDMARD means a drug included in the following list of drugs:
 
 
 
 

 
 
 
 adalimumab, anakinra, etanercept or infliximab; 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 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle;
 
 
 
 

 
 
 
 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;
 
 
 
 

 
 
 
 the authority application includes a completed copy of the appropriate Biological DMARD 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 an initial 16 week 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 treatment 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 severe active rheumatoid arthritis 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
NV

 
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
NV

 
 
 
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
..
JC

 
 
 
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
..
JC

 
 
 
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
..
JC

 
 
 
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
..
JC

 
 
 
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
..
JC

 
 
 
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 Hydrochloride
Tablet equivalent to 2 mg granisetron
 
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
MX

 
Concentrated injection equivalent to 3 mg granisetron in 3 mL ampoule
 
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
..
MX

Hydrocortisone Sodium Succinate
Injection equivalent to 100 mg hydrocortisone with 2 mL solvent
 
For use in a hospital
Injection
6
..
PH

 
Injection equivalent to 250 mg hydrocortisone with 2 mL solvent
 
For use in a hospital
Injection
6
..
PH

Hydromorphone Hydrochloride
Tablet 2 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
40
..
AB

 
 
 
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 4 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
40
..
AB

 
 
 
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 8 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
40
..
AB

 
 
 
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 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
..
AB

 
 
 
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
AB

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
RO

 
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
RO

 
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
RO

 
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
RO

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
SH

"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
NU

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
JC

Lansoprazole
Capsule 30 mg
 
Gastro-oesophageal reflux disease
Scleroderma oesophagus
Oral
30
5
WY

 
Sachet containing granules for oral suspension, 30 mg per sachet
 
Gastro-oesophageal reflux disease
Scleroderma oesophagus
Oral
28
5
WY

 
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
WY

 
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
WY

Lercanidipine Hydrochloride
Tablet 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
SM

 
 
 
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 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
SM

 
 
 
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
UC

 
 
 
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
UC

 
 
 
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
UC

 
 
 
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 Acetate
Tablet 10 mg
 
Endometriosis
Oral
100
2
KR, PH

Methadone Hydrochloride
Tablet 10 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
40
..
GK

 
 
 
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 10 mg in 1 mL ampoule
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Injection
10
..
GK

 
 
 
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
AF, AV, SW

Morphine Hydrochloride
Oral solution 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
..
MF

 
 
 
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 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
..
MF

 
 
 
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 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
..
MF

 
 
 
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
 
 
 
 

Morphine Sulfate
Tablet 30 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
40
..
FM

 
 
 
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 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
..
MF

 
 
 
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 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
..
MF

 
 
 
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 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
..
MF

 
 
 
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 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
..
MF

 
 
 
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 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
..
MF

 
 
 
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 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
..
MF

 
 
 
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 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
..
GK

 
 
 
 
 
 
 

 
 
 
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 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
..
GK

 
 
 
 
 
 
 

 
 
 
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 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
..
MF

 
 
 
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 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
..
GK

 
 
 
 
 
 
 

 
 
 
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 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
..
MF

 
 
 
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 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
..
MF

 
 
 
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 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
..
GK

 
 
 
 
 
 
 

 
 
 
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 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
..
MF

 
 
 
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, 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
..
MF

 
 
 
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, 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
..
MF

 
 
 
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, 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
..
MF

 
 
 
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, 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
..
MF

 
 
 
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 Hydrochloride
Tablet equivalent to 2.5 mg naratriptan
 
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
GK

 
 
 
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
SB

 
 
 
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
SB

 
 
 
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
BN

 
 
 
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
AF, VT

 
 
 
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
HX, WA

 
Capsule 20 mg
 
Gastro-oesophageal reflux disease
Scleroderma oesophagus
Zollinger-Ellison syndrome
Oral
30
5
SZ

Omeprazole Magnesium
Tablet equivalent to 20 mg omeprazole
 
Gastro-oesophageal reflux disease
Scleroderma oesophagus
Zollinger-Ellison syndrome
Oral
30
5
AL, AP, PM

Ondansetron
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
GK, HX, RE

 
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
GK, HX, RE

Ondansetron Hydrochloride Dihydrate
Tablet equivalent to 4 mg ondansetron
 
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
AW, GK, HX, RE

 
Tablet equivalent to 8 mg ondansetron
 
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
AW, GK, HX, RE

 
I.V. injection equivalent to 4 mg ondansetron in 2 mL ampoule
 
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
..
GK, HX, RE

 
I.V. injection equivalent to 8 mg ondansetron in 4 mL ampoule
 
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
..
GK, HX, RE

Oxazepam
Tablet 15 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Malignant neoplasia (late stage)
Oral
50
5
AF, SI

 
 
 
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
AF, FM, SI

 
 
 
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 Hydrochloride
Tablet 5 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
40
..
SI

 
 
 
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 5 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
40
..
MF

 
 
 
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 10 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
40
..
MF

 
 
 
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 20 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Oral
40
..
MF

 
 
 
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 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
Oral
2
..
MF

 
 
 
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 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
..
MF

 
 
 
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 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
..
MF

 
 
 
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 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
..
MF

 
 
 
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 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
..
MF

 
 
 
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 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
..
MF

 
 
 
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
 
 
 
 

Oxycodone Pectinate
Suppository equivalent to 30 mg oxycodone
 
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
Rectal
24
..
PL

 
 
 
 
 
 
 

 
 
 
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 Sodium Sesquihydrate
Tablet (enteric coated), equivalent to 40 mg pantoprazole
 
Gastro-oesophageal reflux disease
Scleroderma oesophagus
Zollinger-Ellison syndrome
Oral
30
5
AH

Paracetamol
Tablet 500 mg
 
Chronic arthropathies
Oral
300
4
AW, CH, FM, GM, HX, JT, PC, SW, TW

Pemetrexed Disodium Heptahydrate
Powder for I.V. infusion equivalent to 500 mg pemetrexed, vial
 
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
LY

 
 
 
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 Potassium
Tablet equivalent to 250 mg phenoxymethylpenicillin
 
Prophylaxis of recurrent streptococcal infections (including rheumatic fever)
Oral
50
5
SI

 
Capsule equivalent to 250 mg phenoxymethylpenicillin
 
Prophylaxis of recurrent streptococcal infections (including rheumatic fever)
Oral
50
5
CS, FM, GM, HX

Rabeprazole Sodium
Tablet 20 mg (enteric coated)
 
Gastro-oesophageal reflux disease
Scleroderma oesophagus
Oral
30
5
JC

Ranitidine Hydrochloride
Tablet, effervescent, equivalent to 150 mg ranitidine
 
In compliance with authority procedures set out in subparagraph 11 (d):
Adverse effects occurring with all of the base-priced drugs
Drug interactions occurring with all of the base-priced drugs
Oral
60
5
GK

 
 
 
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 equivalent to 150 mg ranitidine 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
Drug interactions occurring with all of the base-priced drugs
Oral
2
5
GK

 
 
 
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
..
AF

 
Capsule 300 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Leprosy in adults
 
Oral
100
..
AF

Risperidone
Tablet 0.5 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Oral
60
5
JC

 
 
1589
 Schizophrenia
 
 
 
 

 
Tablet 0.5 mg (orally disintegrating)
 
1589
In compliance with authority procedures set out in subparagraph 11 (d):
 Schizophrenia
Oral
56
5
JC

 
Tablet 1 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Oral
60
5
JC

 
 
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)
 
1589
In compliance with authority procedures set out in subparagraph 11 (d):
 Schizophrenia
Oral
56
5
JC

 
 
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
JC

 
 
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)
 
1589
In compliance with authority procedures set out in subparagraph 11 (d):
 Schizophrenia
Oral
56
5
JC

 
 
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 vial
 
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
RO

 
Solution for I.V. infusion 500 mg in 50 mL vial
 
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
RO

"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
WY

Sertraline Hydrochloride
Tablet equivalent to 50 mg sertraline
 
Obsessive-compulsive disorder
Panic disorder where other treatments have failed or are inappropriate
Oral
30
5
AF, AW, PF

 
Tablet equivalent to 100 mg sertraline
 
Obsessive-compulsive disorder
Panic disorder where other treatments have failed or are inappropriate
Oral
30
5
AF, AW, PF

Temazepam
Tablet 10 mg
 
In compliance with authority procedures set out in subparagraph 11 (d):
Malignant neoplasia (late stage)
Oral
50
5
AF, FM, SI

 
 
 
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
SH

 
 
 
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
SH

 
 
 
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
SH

 
 
 
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
JC

 
 
 
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
JC

 
 
 
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
JC

 
 
 
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
JC

 
 
 
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
JC

 
 
 
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
JC

 
 
 
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
JC

 
 
 
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 Hydrochloride
Capsule 50 mg
 
For dosage titration in chronic pain where aspirin or paracetamol alone is inappropriate or has failed
Oral
20
2
AF, AW, CH, CS, GX, TW

 
Tablet 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
..
CS

 
Tablet 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
..
AW, CS, HX

 
Tablet 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
..
AW, CS, HX

 
Tablet 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
..
AW, CS, HX

 
Oral drops 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
..
CS

Valaciclovir Hydrochloride
Tablet equivalent to 500 mg valaciclovir
 
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
GK

 
Tablet equivalent to 500 mg valaciclovir
 
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
..
GK

Vancomycin Hydrochloride
Powder for injection equivalent to 500 mg (500,000 I.U.) vancomycin activity
 
Endophthalmitis
Use initiated in a hospital for infections where vancomycin hydrochloride is an appropriate antibiotic
Injection
5
..
AS, MX

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
AP

 
 
 
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 Hydrochloride
Mouth and throat rinse 22.5 mg per 15 mL, 500 mL
Oral application
1
..
MM

Bisacodyl
Tablet 5 mg
Oral
200
..
AE, AS

 
Suppositories 10 mg, 10
Rectal
3
..
BY, PP

 
Suppositories 10 mg, 12
Rectal
3
..
FL, PP

 
Enemas 10 mg in 5 mL, 25
Rectal
1
..
AS

Carmellose Sodium
Mouth spray 10 mg per mL, 25 mL
Oral application
1
..
HA

 
Mouth spray 10 mg per mL, 100 mL
Oral application
1
..
HA

Clonazepam
Tablet 500 micrograms
Oral
100
..
AF, RO

 
Tablet 2 mg
Oral
100
..
AF, RO

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

Diazepam
Tablet 2 mg
Oral
50
..
AF, AW, RO, SU

 
Tablet 5 mg
Oral
50
..
AF, AW, GM, RO, SU

Diclofenac Sodium
Tablet 25 mg (enteric coated)
Oral
100
..
AF, AW, CH, GM, GX, HX, NV, TW

 
Tablet 50 mg (enteric coated)
Oral
50
..
AF, AW, CH, GM, GX, HX, NV, TW

 
Suppository 100 mg
Rectal
40
..
NV

Glycerol
Suppositories 700 mg, 12
Rectal
3
..
PP

 
Suppositories 1.4 g, 12
Rectal
3
..
PP

 
Suppositories 2.8 g, 12
Rectal
3
..
PP

Hyoscine Butylbromide
Injection 20 mg in 1 mL ampoule
Injection
5
..
BY

Ibuprofen
Tablet 200 mg
Oral
100
..
AF

 
Tablet 400 mg
Oral
90
..
AB

Indomethacin
Capsule 25 mg
Oral
100
..
AF, MK

 
Suppository 100 mg
Rectal
40
..
MK

Lactulose
Solution BP 3.34 g per 5 mL, 500 mL
Oral
1
..
AF, AW, GM, GX, HX, SM

Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride
Sachets containing powder for oral solution 13.125 g-350.7 mg-178.5 mg-46.6 mg, 30
Oral
1
..
NE

Methadone Hydrochloride
Oral liquid 25 mg per 5 mL, 200 mL
Oral
1
..
GK

Morphine Sulfate
Tablet 10 mg
Oral
20
..
MF

 
Tablet 20 mg
Oral
20
..
MF

 
Tablet 200 mg (controlled release)
Oral
20
..
MF

Naproxen
Tablet 250 mg
Oral
100
..
AF, RO

 
Tablet 500 mg
Oral
50
..
AF, RO

 
Tablet 750 mg (sustained release)
Oral
28
..
MD, RO

 
Tablet 1 g (sustained release)
Oral
28
..
MD, RO

 
Oral suspension 125 mg per 5 mL, 474 mL
Oral
1
..
RO

Naproxen Sodium
Tablet 550 mg
Oral
50
..
MD, RO

Nitrazepam
Tablet 5 mg
Oral
50
..
AF, VT

Oxazepam
Tablet 15 mg
Oral
50
..
AF, SI

 
Tablet 30 mg
Oral
50
..
AF, FM, SI

Paracetamol
Tablet 665 mg (modified release)
Oral
192
..
GC, ME

 
Suppositories 500 mg, 24
Rectal
1
..
GC

Promethazine Hydrochloride
Tablet 10 mg
Oral
50
..
SW

 
Tablet 25 mg
Oral
50
..
SW

 
Oral liquid 5 mg per 5 mL, 100 mL
Oral
1
..
SW

Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate
Enemas 3.125 g-450 mg-45 mg in 5 mL, 12
Rectal
2
..
PH

Sterculia with Frangula Bark
Granules 620 mg-80 mg per g, 500 g
Oral
1
..
NE

Sulindac
Tablet 100 mg
Oral
100
..
AF

 
Tablet 200 mg
Oral
50
..
AF

Temazepam
Tablet 10 mg
Oral
50
..
AF, FM, SI


Benzydamine Hydrochloride
Mouth and throat rinse 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
MM

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
AE, AS

 
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
BY, PP

 
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
FL, PP

 
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
AS

Carmellose Sodium
Mouth spray 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
HA

 
Mouth spray 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
HA

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
AF, RO

 
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
AF, RO

 
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
RO

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
AF, AW, RO, SU

 
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
AF, AW, GM, RO, SU

Diclofenac Sodium
Tablet 25 mg (enteric coated)
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
AF, AW, CH, GM, GX, HX, NV, TW

 
Tablet 50 mg (enteric coated)
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
AF, AW, CH, GM, GX, HX, NV, TW

 
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
NV

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
PP

 
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
PP

 
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
PP

Hyoscine Butylbromide
Injection 20 mg in 1 mL ampoule
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
BY

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
AF

 
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
AB

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
AF, MK

 
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
MK

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
AF, AW, GM, GX, HX, SM

Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride
Sachets containing powder for oral solution 13.125 g-350.7 mg-178.5 mg-46.6 mg, 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
NE

Methadone Hydrochloride
Oral liquid 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
GK

Morphine Sulfate
Tablet 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
MF

 
Tablet 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
MF

 
Tablet 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
MF

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
AF, RO

 
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
AF, RO

 
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
MD, RO

 
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
MD, RO

 
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
RO

Naproxen Sodium
Tablet 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
MD, RO

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
AF, VT

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
AF, SI

 
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
AF, FM, SI

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
GC, ME

 
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
GC

Promethazine Hydrochloride
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 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
SW

 
Tablet 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
SW

 
Oral liquid 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
SW

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
PH

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
NE

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
AF

 
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
AF

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
AF, FM, SI


Adrenaline Acid Tartrate
Injection equivalent to adrenaline 1 in 1,000, 1 mL
Injection
5
..
AP

Amoxycillin Trihydrate
Tablet, chewable, equivalent to 250 mg amoxycillin
Oral
20
..
GK

 
Capsule equivalent to 250 mg amoxycillin
Oral
20
..
AF, CH, GK, GM, GX, HX, SI, TW

 
Capsule equivalent to 500 mg amoxycillin
Oral
20
..
AF, CH, CS, GK, GM, GX, HX, SI, TW

 
Sachet containing oral powder equivalent to 3 g amoxycillin
Oral
1
..
GK

Amoxycillin Trihydrate with Potassium Clavulanate
Tablet equivalent to 500 mg amoxycillin-125 mg clavulanic acid
Oral
10
..
AL, AW, GK, HX, ME, SZ

 
Tablet equivalent to 875 mg amoxycillin-125 mg clavulanic acid
Oral
10
..
AL, AW, CH, GK, GX, HX, ME, SZ, TW

Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP
Powder for oral suspension equivalent to 125 mg amoxycillin-31.25 mg clavulanic acid per 5 mL, 75 mL
Oral
1
..
AL, GK, HX, ME

 
Powder for oral suspension equivalent to 400 mg amoxycillin-57 mg clavulanic acid per 5 mL, 60 mL
Oral
1
..
AL, GK, HX, ME

Amoxycillin Trihydrate with Water - Purified BP
Powder for paediatric oral drops equivalent to 100 mg amoxycillin per mL, 20 mL
Oral
1
..
GK

 
Powder for oral suspension equivalent to 125 mg amoxycillin per 5 mL, 100 mL
Oral
1
..
AF, CH, GK, GM, GX, HX, TW

 
Powder for oral suspension equivalent to 250 mg amoxycillin per 5 mL, 100 mL
Oral
1
..
AF, CH, GK, GM, GX, HX, SI, TW

 
Powder for oral suspension equivalent to 500 mg amoxycillin per 5 mL, 100 mL
Oral
1
..
SZ

Amphotericin
Lozenge 10 mg
Oral
20
..
BQ

Ampicillin Sodium
Powder for injection equivalent to 500 mg ampicillin
Injection
5
..
GM, LN

 
Powder for injection equivalent to 1 g ampicillin
Injection
5
..
AS, GM, LN

Ampicillin Trihydrate
Capsule equivalent to 250 mg ampicillin
Oral
24
..
AF

 
Capsule equivalent to 500 mg ampicillin
Oral
24
..
AF

Aspirin
Tablet, dispersible, 300 mg
Oral
96
..
RC

Atropine Sulfate
Injection 600 micrograms in 1 mL ampoule
Injection
10
..
AP

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

 
Powder for injection 900 mg
Injection
1
..
AS

Benztropine Mesylate
Injection 2 mg in 2 mL ampoule
Injection
5
..
MK

Benzydamine Hydrochloride
Mouth and throat rinse 22.5 mg per 15 mL, 500 mL
Oral application
1
..
MM

Benzylpenicillin Sodium
Powder for injection equivalent to 600 mg benzylpenicillin
Injection
10
..
CS

 
Powder for injection equivalent to 3 g benzylpenicillin
Injection
10
..
CS

Betamethasone Acetate with Betamethasone Sodium Phosphate
Injection 3 mg-3.9 mg in 1 mL ampoule
Injection
5
..
SH

Carbamazepine
Tablet 100 mg
Oral
200
..
NV, SZ

 
Tablet 200 mg
Oral
200
..
AF, NV, SZ

 
Tablet 200 mg (controlled release)
Oral
200
..
NV

 
Tablet 400 mg (controlled release)
Oral
200
..
NV

 
Oral suspension 100 mg per 5 mL, 300 mL
Oral
1
..
NV

Cefaclor Monohydrate
Tablet (sustained release) equivalent to 375 mg cefaclor
Oral
10
..
AF, AS, CH, GM, GX, LN, RA, TW

Cefaclor Monohydrate with Water - Purified BP
Powder for oral suspension equivalent to 125 mg cefaclor per 5 mL, 100 mL
Oral
1
..
AF, AS, AW, CH, GX, TW

 
Powder for oral suspension equivalent to 250 mg cefaclor per 5 mL, 75 mL
Oral
1
..
AF, AS, AW, CH, GX, TW

Cefotaxime Sodium
Powder for injection equivalent to 1 g cefotaxime
Injection
10
..
MX, SZ

 
Powder for injection equivalent to 2 g cefotaxime
Injection
10
..
MX, SZ

Cefuroxime Axetil
Tablet equivalent to 250 mg cefuroxime
Oral
14
..
GK

Cephalexin
Capsule 250 mg (anhydrous)
Oral
20
..
AF, AS, CH, GM, GX, HX, LN, RA, TW

 
Capsule 500 mg (anhydrous)
Oral
20
..
AF, AS, CH, GM, GX, HX, LN, RA, TW

Cephalexin with Water - Purified BP
Granules for oral suspension 125 mg per 5 mL, 100 mL
Oral
1
..
AF, AS, CH, GM, GX, LN, TW

 
Granules for oral suspension 250 mg per 5 mL, 100 mL
Oral
1
..
AF, AS, CH, GM, GX, LN, TW

Cephalothin Sodium
Powder for injection equivalent to 1 g cephalothin
Injection
10
..
AS, MX

Chloramphenicol
Eye drops 5 mg per mL, 10 mL
Application to the eye
1
..
PF, SI

Clindamycin Hydrochloride
Capsule equivalent to 150 mg clindamycin
Oral
25
..
KR, PH

Codeine Phosphate
Tablet 30 mg
Oral
20
..
FM

Codeine Phosphate with Paracetamol
Tablet 30 mg-500 mg
Oral
20
..
AL, AV, CO, FM, GK, SW

Diazepam
Tablet 2 mg
Oral
50
..
AF, AW, RO, SU

 
Tablet 5 mg
Oral
50
..
AF, AW, GM, RO, SU

 
Injection 10 mg in 2 mL ampoule
Injection
5
..
MX

Diclofenac Sodium
Tablet 25 mg (enteric coated)
Oral
100
..
AF, AW, CH, GM, GX, HX, NV, TW

 
Tablet 50 mg (enteric coated)
Oral
50
..
AF, AW, CH, GM, GX, HX, NV, TW

 
Suppository 100 mg
Rectal
40
..
NV

Dicloxacillin Sodium
Capsule equivalent to 250 mg dicloxacillin
Oral
24
..
AF, BQ, SI

 
Capsule equivalent to 500 mg dicloxacillin
Oral
24
..
AF, BQ, SI

 
Powder for injection equivalent to 500 mg dicloxacillin
Injection
5
..
BQ

 
Powder for injection equivalent to 1 g dicloxacillin
Injection
5
..
BQ

Doxycycline Hydrochloride
Tablet equivalent to 100 mg doxycycline
Oral
7
..
AF, GM, PF, SI

 
Capsule equivalent to 100 mg doxycycline (containing enteric coated pellets)
Oral
7
..
FA, MX

Doxycycline Monohydrate
Tablet equivalent to 100 mg doxycycline
Oral
7
..
CH, GX, SZ, TW

Erythromycin
Capsule 250 mg (containing enteric coated pellets)
Oral
25
..
FA, MX

Erythromycin Ethyl Succinate
Tablet equivalent to 400 mg erythromycin
Oral
25
..
AB, AF

Erythromycin Ethyl Succinate with Water - Purified BP
Powder for oral liquid equivalent to 200 mg erythromycin per 5 mL, 100 mL
Oral
1
..
AB, AF

 
Powder for oral liquid equivalent to 400 mg erythromycin per 5 mL, 100 mL
Oral
1
..
AB, AF

Erythromycin Lactobionate
Powder for I.V. infusion equivalent to 1 g erythromycin, vial
Injection
5
..
AB

Flucloxacillin Magnesium with Water - Purified BP
Powder for oral suspension equivalent to 125 mg flucloxacillin per 5 mL, 100 mL
Oral
1
..
GK

 
Powder for oral suspension equivalent to 250 mg flucloxacillin per 5 mL, 100 mL
Oral
1
..
CS, GK

Flucloxacillin Sodium
Capsule equivalent to 250 mg flucloxacillin
Oral
24
..
AF, CS, GK, SI

 
Capsule equivalent to 500 mg flucloxacillin
Oral
24
..
AF, CS, GK, SI

 
Powder for injection equivalent to 500 mg flucloxacillin
Injection
5
..
CS, GM

 
Powder for injection equivalent to 1 g flucloxacillin
Injection
5
..
AS, CS, GM, MX

Glucagon Hydrochloride
Injection set containing 1 mg (1 I.U.) and 1 mL solvent in disposable syringe
Injection
1
..
NO

Glucose
I.V. infusion 278 mmol (anhydrous) per L, 1 L
Injection
5
..
BX

Glyceryl Trinitrate
Tablets 600 micrograms, 100
Oral
1
..
FM, SI

Hydrocortisone Acetate
Cream 10 mg per g, 30 g
Application
1
..
FM, SI

 
Cream 10 mg per g, 50 g
Application
1
..
DT, FM, SI

 
Ointment 10 mg per g, 30 g
Application
1
..
FM, SI

 
Ointment 10 mg per g, 50 g
Application
1
..
FM, SI

Hydrocortisone Sodium Succinate
Injection equivalent to 100 mg hydrocortisone with 2 mL solvent
Injection
6
..
PH

 
Injection equivalent to 250 mg hydrocortisone with 2 mL solvent
Injection
6
..
PH

Hydromorphone Hydrochloride
Tablet 2 mg
Tablet 4 mg
Oral
Oral
20
20
..
..
AB
AB

 
Tablet 8 mg
Oral
20
..
AB

 
Oral liquid 1 mg per mL, 473 mL
Oral
1
..
AB

 
Injection 2 mg in 1 mL ampoule
Injection
5
..
AB

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

 
Injection 50 mg in 5 mL ampoule
Injection
5
..
AB

Ibuprofen
Tablet 200 mg
Oral
100
..
AF

 
Tablet 400 mg
Oral
30
..
AB

Indomethacin
Capsule 25 mg
Oral
100
..
AF, MK

 
Suppository 100 mg
Rectal
40
..
MK

Ketoprofen
Capsule 200 mg (sustained release)
Oral
28
..
AV, SW

 
Suppository 100 mg
Rectal
40
..
SW

Lignocaine Hydrochloride
Injection 100 mg in 5 mL
Injection
5
..
PF

Lincomycin Hydrochloride
Injection equivalent to 600 mg lincomycin in 2 mL vial
Injection
5
..
PH

Methylprednisolone Acetate
Injection 40 mg in 1 mL vial
Injection
5
..
KR, PH

Metoclopramide Hydrochloride
Tablet 10 mg
Injection 10 mg in 2 mL ampoule
Oral
Injection
25
10
..
..
AF, VT
VT

Metronidazole
Tablet 200 mg
Oral
21
..
AF, AV, SW

 
Tablet 400 mg
Oral
5
..
AF

 
I.V. infusion 500 mg in 100 mL
Injection
5
..
BX

 
Suppositories 500 mg, 10
Rectal
1
..
SW

Metronidazole Benzoate
Oral suspension 320 mg per 5 mL, 100 mL
Oral
1
..
SW

Morphine Hydrochloride
Oral solution 2 mg per mL, 200 mL
Oral
1
..
MF

 
Oral solution 5 mg per mL, 200 mL
Oral
1
..
MF

 
Oral solution 10 mg per mL, 200 mL
Oral
1
..
MF

Morphine Sulfate
Tablet 30 mg
Oral
20
..
FM

 
Tablet 5 mg (controlled release)
Oral
20
..
MF

 
Tablet 10 mg (controlled release)
Oral
20
..
MF

 
Tablet 15 mg (controlled release)
Oral
20
..
MF

 
Tablet 30 mg (controlled release)
Oral
20
..
MF

 
Tablet 60 mg (controlled release)
Oral
20
..
MF

 
Tablet 100 mg (controlled release)
Oral
20
..
MF

 
Capsule 10 mg (containing sustained release pellets)
Oral
20
..
GK

 
Capsule 20 mg (containing sustained release pellets)
Oral
20
..
GK

 
Capsule 30 mg (controlled release)
Oral
10
..
MF

 
Capsule 50 mg (containing sustained release pellets)
Oral
20
..
GK

 
Capsule 60 mg (controlled release)
Oral
10
..
MF

 
Capsule 90 mg (controlled release)
Oral
10
..
MF

 
Capsule 100 mg (containing sustained release pellets)
Oral
20
..
GK

 
Capsule 120 mg (controlled release)
Oral
10
..
MF

 
Sachet containing controlled release granules for oral suspension, 20 mg per sachet
Oral
20
..
MF

 
Sachet containing controlled release granules for oral suspension, 30 mg per sachet
Oral
20
..
MF

 
Sachet containing controlled release granules for oral suspension, 60 mg per sachet
Oral
20
..
MF

 
Sachet containing controlled release granules for oral suspension, 100 mg per sachet
Oral
20
..
MF

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

 
Injection 15 mg in 1 mL ampoule
Injection
5
..
MX

 
Injection 30 mg in 1 mL ampoule
Injection
5
..
MX

Naloxone Hydrochloride
Injection 800 micrograms in 2 mL disposable injection set
Injection
1
..
CS

 
Injection 2 mg in 5 mL disposable injection set
Injection
1
..
CS

Naproxen
Tablet 250 mg
Oral
100
..
AF, RO

 
Tablet 500 mg
Oral
50
..
AF, RO

 
Tablet 750 mg (sustained release)
Oral
28
..
MD, RO

 
Tablet 1 g (sustained release)
Oral
28
..
MD, RO

Naproxen Sodium
Tablet 550 mg
Oral
50
..
MD, RO

Nitrazepam
Tablet 5 mg
Oral
25
..
AF, VT

Nystatin
Tablet 500,000 units
Oral
50
..
SI

 
Capsule 500,000 units
Oral
50
..
SI

 
Oral suspension 100,000 units per mL, 24 mL
Oral
1
..
BQ, SI

Oxazepam
Tablet 15 mg
Oral
25
..
AF, SI

 
Tablet 30 mg
Oral
25
..
AF, FM, SI

Oxycodone Hydrochloride
Tablet 5 mg
Oral
20
..
SI

 
Capsule 5 mg
Oral
20
..
MF

 
Capsule 10 mg
Oral
20
..
MF

 
Capsule 20 mg
Oral
20
..
MF

 
Oral solution 5 mg per 5 mL, 250 mL
Oral
1
..
MF

 
Tablet 5 mg (controlled release)
Oral
20
..
MF

 
Tablet 10 mg (controlled release)
Oral
20
..
MF

 
Tablet 20 mg (controlled release)
Oral
20
..
MF

 
Tablet 40 mg (controlled release)
Oral
20
..
MF

 
Tablet 80 mg (controlled release)
Oral
20
..
MF

Oxycodone Pectinate
Suppository equivalent to 30 mg oxycodone
Rectal
12
..
PL

Paracetamol
Tablet 500 mg
Oral
100
..
AW, CH, FM, GM, HX, JT, PC, SW, TW

 
Oral liquid 120 mg per 5 mL, 100 mL
Oral
1
..
SW

 
Oral liquid 240 mg per 5 mL, 200 mL
Oral
1
..
SW

Phenoxymethylpenicillin Benzathine
Oral suspension equivalent to 125 mg phenoxymethylpenicillin per 5 mL, 100 mL
Oral
2
..
FM, SI

 
Oral suspension equivalent to 250 mg phenoxymethylpenicillin per 5 mL, 100 mL
Oral
2
..
FM, SI

Phenoxymethylpenicillin Potassium
Tablet equivalent to 250 mg phenoxymethylpenicillin
Oral
50
..
SI

 
Tablet equivalent to 500 mg phenoxymethylpenicillin
Oral
50
..
SI

 
Capsule equivalent to 250 mg phenoxymethylpenicillin
Oral
50
..
CS, FM, GM, HX

 
Capsule equivalent to 500 mg phenoxymethylpenicillin
Oral
50
..
CS, FM, GM, HX

Piroxicam
Dispersible tablet 10 mg
Oral
50
..
AF, GX, HX, PF

 
Dispersible tablet 20 mg
Oral
25
..
AF, CH, GX, HX, PF, TW

 
Capsule 10 mg
Oral
50
..
AF, CH, GX, PF, TW

 
Capsule 20 mg
Oral
25
..
AF, CH, GX, PF, TW

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

Prochlorperazine
Suppositories 3 mg, equivalent to 5 mg prochlorperazine maleate, 5
Rectal
1
..
SW

 
Suppositories 15 mg, equivalent to 25 mg prochlorperazine maleate, 5
Rectal
1
..
SW

Prochlorperazine Maleate
Tablet 5 mg
Oral
25
..
AV, SW

Prochlorperazine Mesylate
Injection 12.5 mg in 1 mL ampoule
Injection
10
..
SW

Promethazine Hydrochloride
Injection 50 mg in 2 mL ampoule
Injection
10
..
MX

Sodium Chloride
Injection 9 mg per mL, 10 mL
Injection
5
..
PF

 
I.V. infusion 154 mmol per L, 1 L
Injection
5
..
BX

 
I.V. infusion 513 mmol per L, 1 L
Injection
2
..
BX

Sodium Chloride with Glucose
I.V. infusion 31 mmol-222 mmol (anhydrous) per L, 1 L
Injection
5
..
BX

 
I.V. infusion 19 mmol-104 mmol (anhydrous) per 500 mL, 500 mL
Injection
5
..
BX

 
I.V. infusion 39 mmol-69 mmol (anhydrous) per 500 mL, 500 mL
Injection
5
..
BX

Sulindac
Tablet 100 mg
Oral
100
..
AF

 
Tablet 200 mg
Oral
50
..
AF

Temazepam
Tablet 10 mg
Oral
25
..
AF, FM, SI

Ticarcillin Sodium with Potassium Clavulanate with any determined brand of Sodium Chloride Injection
Powder for injection equivalent to 3 g ticarcillin-100 mg clavulanic acid (with required solvent)
Injection
10
..
GK

Tramadol Hydrochloride
Capsule 50 mg
Oral
20
..
AF, AW, CH, CS, GX, TW

 
Tablet 50 mg (sustained release)
Oral
20
..
CS

 
Tablet 100 mg (sustained release)
Oral
20
..
AW, CS, HX

 
Tablet 150 mg (sustained release)
Oral
20
..
AW, CS, HX

 
Tablet 200 mg (sustained release)
Oral
20
..
AW, CS, HX

 
Oral drops 100 mg per mL, 10 mL
Oral
1
..
CS

 
Injection 100 mg in 2 mL ampoule
Injection
5
..
CS, HX

Triamcinolone Acetonide
Injection 10 mg in 1 mL ampoule
Injection
5
..
BQ

Trimethoprim with Sulfamethoxazole
Tablet 80 mg-400 mg
Tablet 160 mg-800 mg
Oral
Oral
10
10
..
..
AF, SI
AF, CH, GX, RO, SI, TW

 

 
Paediatric oral suspension 40 mg-200 mg per 5 mL, 100 mL
Oral
1
..
AF, RO, SI

Vancomycin Hydrochloride
Powder for injection equivalent to 500 mg (500,000 I.U.) vancomycin activity
Injection
2
..
AS, MX


Ibuprofen
Tablet 400 mg
Chronic arthropathies (including osteoarthritis) with an inflammatory component
Bone pain due to malignant disease
Oral
90
..
AB

Metronidazole
Tablet 400 mg
Treatment of anaerobic infections
Oral
21
..
AF, AV, SW

Paracetamol
Tablet 500 mg
Chronic arthropathies
Oral
300
..
AW, CH, FM, GM, HX, JT, PC, SW, TW


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

 
 
Dated this 7th day of June 2007.
 
 
 
 
 
STEPHEN DELLAR
Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
Delegate of the Minister for Health and Ageing