National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 5) (PB 47 of 2015)

Link to law: https://www.comlaw.gov.au/Details/F2015L00762

PB 47 of 2015
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015
(No. 5)
National Health Act 1953
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 22 May                                                             2015
 
 
 
 
 
 
 
 
 
 
 
 
 
FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health
 
1          Name of Instrument
            (1)        This Instrument is the National Health (Listing of Pharmaceutical                            Benefits) Amendment Instrument 2015 (No. 5).
            (2)        This Instrument may also be cited as PB 47 of 2015.
2          Commencement
This Instrument commences on 1 June 2015.
3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
            Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
 
Schedule 1     Amendments
[1]           Schedule 1, entry for Abciximab
omit from the column headed “Circumstances”:        C1716  C1717  C1718    substitute:             C4915  C4942  C4943
[2]           Schedule 1, entry for Aciclovir in the form Tablet 200 mg [Maximum Quantity: 50; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Aciclovir Sandoz
HX
MP NP
C3632 C3633
P3632
50
0
25
 
 
[3]           Schedule 1, entry for Aciclovir in the form Tablet 200 mg [Maximum Quantity: 90; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Aciclovir Sandoz
HX
MP NP
C3632 C3633
P3633
90
5
90
 
 
[4]           Schedule 1, entry for Adapalene with benzoyl peroxide in the form Gel 1 mg-25 mg per g, 30 g [Maximum Quantity: 1;
Number of Repeats: 1]
(a)      omit from the column headed “Circumstances”:            C3689  C3690    substitute:          C4898  C4961
(b)      omit from the column headed “Purposes”:       P3689   substitute:          P4961 
[5]           Schedule 1, entry for Adapalene with benzoyl peroxide in the form Gel 1 mg-25 mg per g, 30 g [Maximum Quantity: 1;
Number of Repeats: 3]
(a)      omit from the column headed “Circumstances” [Authorised Prescriber “MP”]:     C3689  C3690    substitute:    C4898  C4961
(b)      omit from the column headed “Purposes”:       P3690   substitute:          P4898 
(c)      omit from the column headed “Circumstances” [Authorised Prescriber “NP”]:      C3690   substitute:          C4898
[6]           Schedule 1, entry for Adrenaline in each of the forms: I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector
(EpiPen Jr.); I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector (Anapen Junior); I.M. injection 300 micrograms
in 0.3 mL single dose syringe auto-injector (EpiPen); and I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector (Anapen)
omit from the column headed “Circumstances”:        C3434  C3435  C3436    substitute:             C4909  C4946  C4947
[7]           Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol
omit from the column headed “Brand”:       FonatPlus        substitute:             FonatPLUS
[8]           Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol
omit from the column headed “Brand”:       Fonat Plus       substitute:             FonatPLUS
 
[9]           Schedule 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine in the form Sachets containing oral powder 34 g, 30 (PKU express 20)
insert in the columns in the order indicated:
 
Sachets containing oral powder 36 g, 30 (PKU Anamix Junior)
Oral
PKU Anamix Junior
SB
MP NP
C4964
 
4
5
1
 
 
[10]         Schedule 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine in the form Sachets containing oral powder 29 g, 30 (TYR Anamix Junior)
insert in the columns in the order indicated:
 
Sachets containing oral powder 36 g, 30 (TYR Anamix Junior)
Oral
TYR Anamix Junior
SB
MP NP
C4923
 
4
5
1
 
 
[11]         Schedule 1, after entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine in the form Sachets containing oral powder 34 g, 30 (MSUD express 20)
insert in the columns in the order indicated:
 
Sachets containing oral powder 36 g, 30 (MSUD Anamix Junior)
Oral
MSUD Anamix Junior
SB
MP NP
C4954
 
4
5
1
 
 
[12]         Schedule 1, after entry for Amylopectin, modified long chain
insert:
Anakinra
Injection 100 mg in 0.67 mL single use pre-filled syringe
Injection
Kineret
FK
MP
C4920
 
28
5
28
 
D(100)
[13]         Schedule 1, entry for Apraclonidine
omit from the column headed “Circumstances”:        C1374   substitute:             C4901
[14]         Schedule 1, entry for Atenolol in the form Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Atenolol RBX
RA
MP NP
 
 
30
5
30
 
 
[15]         Schedule 1, entry for Azathioprine in the form Tablet 50 mg
omit from the column headed “Brand”:       Thioprine         substitute:             Thioprine 50
[16]         Schedule 1, entry for Betamethasone in the form Cream 500 micrograms (as dipropionate) per g, 15 g
omit from the column headed “Circumstances” (twice occurring):       C1422   substitute:             C4957
[17]         Schedule 1, entry for Betamethasone in the form Cream 200 micrograms (as valerate) per g, 100 g
omit from the column headed “Circumstances” (all instances):            C1422   substitute:             C4924
 
[18]         Schedule 1, entry for Betamethasone in each of the forms: Ointment 500 micrograms (as dipropionate) per g, 15 g; and
Cream 500 micrograms (as valerate) per g, 15 g
omit from the column headed “Circumstances” (all instances):            C1422   substitute:             C4957
[19]         Schedule 1, entry for Bevacizumab in each of the forms: Solution for I.V. infusion 100 mg in 4 mL; and Solution for I.V. infusion 400 mg
in 16 mL
insert in numerical order in the column headed “Circumstances”:       C4939  C4968 
[20]         Schedule 1, entry for Bivalirudin
omit from the column headed “Circumstances”:        C3075   substitute:             C4919
[21]         Schedule 1, entry for Buprenorphine in each of the forms: Transdermal patch 5 mg; Transdermal patch 10 mg; and Transdermal patch
20 mg
omit from the column headed “Circumstances”:        C1062   substitute:             C4951
[22]         Schedule 1, omit entry for Calcipotriol
[23]         Schedule 1, entry for Captopril in the form Oral solution 5 mg per mL, 95 mL
omit from the column headed “Circumstances”:        C1998   substitute:             C4966
[24]         Schedule 1, entry for Celecoxib in each of the forms: Capsule 100 mg; and Capsule 200 mg
omit from the column headed “Circumstances” (all instances):            C1547  C1848    substitute:             C4907  C4962
[25]         Schedule 1, entry for Cetuximab in each of the forms: Solution for I.V. infusion 100 mg in 20 mL; and Solution for I.V. infusion 500 mg
in 100 mL
(a)      omit from the column headed “Circumstances”:            C4771  C4779
(b)      insert in numerical order:     C4908  C4912  C4945  C4965
[26]         Schedule 1, entry for Chloramphenicol
omit:
 
Ear drops (aqueous) 5 mg per mL, 5 mL
Application to the ear
Chloromycetin
PF
MP NP
 
 
1
2
1
 
 
[27]         Schedule 1, entry for Ciprofloxacin in the form Tablet 750 mg (as hydrochloride)
omit:
 
 
 
Ciproxin 750
BN
MP NP
C1431 C1432 C1572 C1573 C3680
 
14
0
14
 
 
[28]         Schedule 1, entry for Clodronic Acid in each of the forms: Capsule containing 400 mg sodium clodronate (as tetrahydrate); and
Tablet containing 800 mg sodium clodronate (as tetrahydrate)
omit from the column headed “Circumstances”:        C1035  C1205  C1233    substitute:             C4933  C4955  C4956
 
[29]         Schedule 1, entry for Codeine with Paracetamol in the form Tablet containing codeine phosphate 30 mg with paracetamol 500 mg [Maximum Quantity: 60; Number of Repeats: 0]
(a)      omit from the column headed “Purposes” (all instances):               P2064   substitute:          P4903
(b)      omit from the column headed “Maximum Quantity” (all instances):          60 CN2064        substitute:          60 CN4903
(c)      omit from the column headed “Number of Repeats” (all instances):          0          substitute:          0 CN4903
[30]         Schedule 1, entry for Dalteparin in the form Injection containing dalteparin sodium 2,500 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe [Maximum Quantity: 20; Number of Repeats: 3]
omit from the column headed “Purposes”:   P1148   substitute:             P4910
[31]         Schedule 1, entry for Dalteparin in the form Injection containing dalteparin sodium 5,000 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe [Maximum Quantity: 20; Number of Repeats: 3]
omit from the column headed “Purposes”:   P1148   substitute:             P4910
[32]         Schedule 1, entry for Dalteparin in the form Injection containing dalteparin sodium 7,500 I.U. (anti-Xa) in 0.75 mL single dose pre-filled syringe [Maximum Quantity: 20; Number of Repeats: 3]
omit from the column headed “Purposes”:   P1148   substitute:             P4910
[33]         Schedule 1, entry for Dalteparin in the form Injection containing dalteparin sodium 7,500 I.U. (anti-Xa) in 0.75 mL single dose pre-filled syringe [Maximum Quantity: 30; Number of Repeats: 5]
omit from the column headed “Purposes”:   P3688   substitute:             P4967
[34]         Schedule 1, entry for Dalteparin in the form Injection containing dalteparin sodium 10,000 I.U. (anti-Xa) in 1 mL single dose pre‑filled syringe [Maximum Quantity: 20; Number of Repeats: 3]
omit from the column headed “Purposes”:   P1148   substitute:             P4910
[35]         Schedule 1, entry for Dalteparin in the form Injection containing dalteparin sodium 10,000 I.U. (anti-Xa) in 1 mL single dose pre‑filled syringe [Maximum Quantity: 30; Number of Repeats: 5]
omit from the column headed “Purposes”:   P3688   substitute:             P4967
[36]         Schedule 1, entry for Dalteparin in the form Injection containing dalteparin sodium 12,500 I.U. (anti-Xa) in 0.5 mL single dose pre-filled syringe
omit:
 
 
 
 
 
MP NP
 
P1148
20
3
10
 
 

 
 
 
 
 
MP NP
 
P3688
20
3
10
 
 

substitute:
 
 
 
 
 
MP NP
 
P4910
20
3
10
 
 

 
 
 
 
 
MP NP
 
P4967
30
5
10
 
 

[37]         Schedule 1, entry for Dalteparin in each of the forms: Injection containing dalteparin sodium 15,000 I.U. (anti-Xa) in 0.6 mL single dose pre-filled syringe; and Injection containing dalteparin sodium 18,000 I.U. (anti-Xa) in 0.72 mL single dose pre-filled syringe
omit from the column headed “Circumstances”:        C3688   substitute:             C4967
[38]         Schedule 1, entry for Diphtheria and tetanus vaccine, adsorbed, diluted for adult use in the form Injection 0.5 mL
omit from the column headed “Section 100/Prescriber Bag only”:       PB(MP)  PB(NP)
[39]         Schedule 1, entry for Dipyridamole with Aspirin
(a)      omit from the column headed “Manner of Administration” for the brand “Asasantin SR”:    Oral
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Diasp SR
QA
MP NP
C1728
 
60
5
60
 
 
[40]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 1 mL
omit:
 
 
 
Dotax
RZ
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[41]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 4 mL
omit:
 
 
 
Dotax
RZ
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[42]         Schedule 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Depreta 30
DO
MP NP
C1211
 
28
0
28
 
 
[43]         Schedule 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Depreta 60
DO
MP NP
C1211
 
28
5
28
 
 
[44]         Schedule 1, entry for Enoxaparin in the form Solution for injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in 0.4 mL [Maximum Quantity: 20; Number of Repeats: 3]
omit from the column headed “Purposes”:   P1148   substitute:             P4910
[45]         Schedule 1, entry for Eplerenone in each of the forms: Tablet 25 mg; and Tablet 50 mg
omit from the column headed “Circumstances”:        C2637   substitute:             C4937 
[46]         Schedule 1, entry for Essential amino acids formula
omit from the column headed “Circumstances”:        C1147  C1458    substitute:             C4925  C4958 
[47]         Schedule 1, entry for Essential amino acids formula with minerals and vitamin C
omit from the column headed “Circumstances”:        C1147  C1458    substitute:             C4925  C4958 
[48]         Schedule 1, entry for Essential amino acids formula with vitamins and minerals
omit from the column headed “Circumstances”:        C1147  C1458    substitute:             C4925  C4958 
[49]         Schedule 1, entry for Ethacrynic Acid
omit from the column headed “Circumstances”:        C1261   substitute:          C4936
[50]         Schedule 1, entry for Fentanyl in the form Lozenge 200 micrograms (as citrate) [Maximum Quantity: 9; Number of Repeats: 0)
omit from the column headed “Circumstances”:        C4267   substitute:             C4914
[51]         Schedule 1, entry for Fentanyl in the form Lozenge 200 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0)
(a)      omit from the column headed “Circumstances”:               C4267   substitute:          C4914
(b)      omit from the column headed “Purposes”:       P4267   substitute:          P4914
[52]         Schedule 1, entry for Fentanyl in the form Lozenge 400 micrograms (as citrate) [Maximum Quantity: 9; Number of Repeats: 0)
omit from the column headed “Circumstances”:        C4267   substitute:             C4914
[53]         Schedule 1, entry for Fentanyl in the form Lozenge 400 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0)
(a)      omit from the column headed “Circumstances”:               C4267   substitute:          C4914
(b)      omit from the column headed “Purposes”:       P4267   substitute:          P4914
[54]         Schedule 1, entry for Fentanyl in the form Lozenge 600 micrograms (as citrate) [Maximum Quantity: 9; Number of Repeats: 0)
omit from the column headed “Circumstances”:        C4267   substitute:             C4914
[55]         Schedule 1, entry for Fentanyl in the form Lozenge 600 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0)
(a)      omit from the column headed “Circumstances”:               C4267   substitute:          C4914
(b)      omit from the column headed “Purposes”:       P4267   substitute:          P4914
[56]         Schedule 1, entry for Fentanyl in the form Lozenge 800 micrograms (as citrate) [Maximum Quantity: 9; Number of Repeats: 0)
omit from the column headed “Circumstances”:        C4267   substitute:             C4914
[57]         Schedule 1, entry for Fentanyl in the form Lozenge 800 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0)
(a)      omit from the column headed “Circumstances”:               C4267   substitute:          C4914
(b)      omit from the column headed “Purposes”:       P4267   substitute:          P4914
[58]         Schedule 1, entry for Fentanyl in the form Lozenge 1200 micrograms (as citrate) [Maximum Quantity: 9; Number of Repeats: 0)
omit from the column headed “Circumstances”:        C4267   substitute:             C4914
[59]         Schedule 1, entry for Fentanyl in the form Lozenge 1200 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0)
(a)      omit from the column headed “Circumstances”:               C4267   substitute:          C4914
(b)      omit from the column headed “Purposes”:       P4267   substitute:          P4914
[60]         Schedule 1, entry for Fentanyl in the form Lozenge 1600 micrograms (as citrate) [Maximum Quantity: 9; Number of Repeats: 0)
omit from the column headed “Circumstances”:        C4267   substitute:             C4914
[61]         Schedule 1, entry for Fentanyl in the form Lozenge 1600 micrograms (as citrate) [Maximum Quantity: 60; Number of Repeats: 0)
(a)      omit from the column headed “Circumstances”:               C4267   substitute:          C4914
(b)      omit from the column headed “Purposes”:       P4267   substitute:          P4914
[62]         Schedule 1, entry for Fentanyl in each of the forms: Transdermal patch 1.28 mg; Transdermal patch 2.063 mg; Transdermal patch 2.1 mg; Transdermal patch 2.55 mg; Transdermal patch 4.125 mg; Transdermal patch 4.2 mg; Transdermal patch 5.10 mg; Transdermal patch 7.65 mg; Transdermal patch 8.25 mg; Transdermal patch 8.4 mg; Transdermal patch 10.20 mg; Transdermal patch 12.375 mg; Transdermal patch 12.6 mg; Transdermal patch 16.5 mg; and Transdermal patch 16.8 mg
omit from the column headed “Circumstances” (all instances):            C1062   substitute:             C4952
[63]         Schedule 1, entry for Fluticasone with Salmeterol in each of the forms: Pressurised inhalation containing fluticasone propionate 50 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation); Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation); Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses; and Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses
omit from the column headed “Circumstances”:        C4408   substitute:             C4930
[64]         Schedule 1, entry for Fluticasone with Salmeterol in each of the forms: Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation); and Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses
(a)      omit from the column headed “Circumstances”:            C4408 
(b)      insert in numerical order:     C4930 
[65]         Schedule 1, entry for Frusemide in each of the forms: Tablet 20 mg; and Tablet 40 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Frusemide RBX
RA
MP NP
 
 
100
1
100
 
 
[66]         Schedule 1, entry for Fusidic Acid
omit from the column headed “Circumstances”:        C1130   substitute:             C4963
[67]         Schedule 1, entry for Gabapentin in the form Capsule 100 mg
omit:
 
 
 
Gabatine 100
QA
MP NP
C2664
 
100
5
100
 
 
[68]         Schedule 1, entry for Gabapentin in the form Capsule 300 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Gabapentin GH
GQ
MP NP
C2664
 
100
5
100
 
 
(b)      omit:
 
 
 
Gabatine 300
QA
MP NP
C2664
 
100
5
100
 
 
 
[69]         Schedule 1, entry for Gabapentin in the form Capsule 400 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Gabapentin GH
GQ
MP NP
C2664
 
100
5
100
 
 
(b)      omit:
 
 
 
Gabatine 400
QA
MP NP
C2664
 
100
5
100
 
 
[70]         Schedule 1, entry for Gabapentin in the form Tablet 600 mg
omit:
 
 
 
Gabatine 600
QA
MP NP
C2664
 
100
5
100
 
 
[71]         Schedule 1, entry for Gabapentin in the form Tablet 800 mg
omit:
 
 
 
Gabatine 800
QA
MP NP
C2664
 
100
5
100
 
 
[72]         Schedule 1, entry for Hydrocortisone in the form Cream containing hydrocortisone acetate 10 mg per g, 30 g [Maximum Quantity: 1;
Number of Repeats: 0]
(a)      omit from the column headed “Circumstances” (twice occurring):           C1422   substitute:          C4899  C4934 
(b)      insert in the column headed “Purposes” (twice occurring):                     P4934
[73]         Schedule 1, entry for Hydrocortisone in the form Cream containing hydrocortisone acetate 10 mg per g, 30 g [Maximum Quantity: 1;
Number of Repeats: 1]
(a)      omit from the column headed “Circumstances” (twice occurring):           C1422   substitute:          C4899  C4934 
(b)      insert in the column headed “Purposes” (twice occurring):                     P4899
[74]         Schedule 1, entry for Hydrocortisone in the form Cream containing hydrocortisone acetate 10 mg per g, 50 g [Maximum Quantity: 1;
Number of Repeats: 0]
(a)      omit from the column headed “Circumstances” (twice occurring):           C1422   substitute:          C4899  C4934 
(b)      insert in the column headed “Purposes” (twice occurring):                     P4934
[75]         Schedule 1, entry for Hydrocortisone in the form Cream containing hydrocortisone acetate 10 mg per g, 50 g [Maximum Quantity: 1;
Number of Repeats: 1]
(a)      omit from the column headed “Circumstances” (twice occurring):           C1422   substitute:          C4899  C4934 
(b)      insert in the column headed “Purposes” (twice occurring):                     P4899
[76]         Schedule 1, entry for Hydrocortisone in the form Ointment containing hydrocortisone acetate 10 mg per g, 30 g [Maximum Quantity: 1;
Number of Repeats: 0]
(a)      omit from the column headed “Circumstances” (twice occurring):           C1422   substitute:          C4899  C4934 
(b)      insert in the column headed “Purposes” (twice occurring):                     P4934
 
[77]         Schedule 1, entry for Hydrocortisone in the form Ointment containing hydrocortisone acetate 10 mg per g, 30 g [Maximum Quantity: 1;
Number of Repeats: 1]
(a)      omit from the column headed “Circumstances” (twice occurring):           C1422   substitute:          C4899  C4934 
(b)      insert in the column headed “Purposes” (twice occurring):                     P4899
[78]         Schedule 1, entry for Hydrocortisone in the form Ointment containing hydrocortisone acetate 10 mg per g, 50 g [Maximum Quantity: 1;
Number of Repeats: 0]
(a)      omit from the column headed “Circumstances” (twice occurring):           C1422   substitute:          C4899  C4934 
(b)      insert in  the column headed “Purposes” (twice occurring):                    P4934
[79]         Schedule 1, entry for Hydrocortisone in the form Ointment containing hydrocortisone acetate 10 mg per g, 50 g [Maximum Quantity: 1;
Number of Repeats: 1]
(a)      omit from the column headed “Circumstances” (twice occurring):           C1422   substitute:          C4899  C4934 
(b)      insert in  the column headed “Purposes” (twice occurring):                    P4899
[80]         Schedule 1, entry for Hydromorphone in each of the forms: Tablet containing hydromorphone hydrochloride 2 mg; Tablet containing hydromorphone hydrochloride 4 mg; and Tablet containing hydromorphone hydrochloride 8 mg
omit from the column headed “Circumstances” (all instances):            C1358   substitute:             C4926  C4959
[81]         Schedule 1, entry for Hydromorphone in each of the forms: Tablet (modified release) containing hydromorphone hydrochloride 4 mg; Tablet (modified release) containing hydromorphone hydrochloride 8 mg; Tablet (modified release) containing hydromorphone hydrochloride 16 mg; Tablet (modified release) containing hydromorphone hydrochloride 32 mg; and Tablet (modified release) containing hydromorphone hydrochloride 64 mg
omit from the column headed “Circumstances”:        C1062   substitute:             C4556 
[82]         Schedule 1, entry for Hydromorphone in the form Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 473 mL
omit from the column headed “Circumstances”:        C1358   substitute:             C4926  C4959
[83]         Schedule 1, entry for Hydroxychloroquine
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Hydroxychloroquine RBX
RA
MP NP
 
 
100
1
100
 
 
[84]         Schedule 1, entry for Ibandronic acid in the form Tablet 50 mg (as ibandronate sodium monohydrate)
omit from the column headed “Circumstances”:        C1035   substitute:             C4922 
[85]         Schedule 1, entry for Icatibant
omit from the column headed “Circumstances”:        C4055  C4056    substitute:             C4917  C4949 
[86]         Schedule 1, entry for Lamotrigine in each of the forms: Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Logem
AL
MP NP
C1426
 
56
5
56
 
 
[87]         Schedule 1, entry for Lansoprazole in the form Tablet 30 mg (orally disintegrating) [Maximum Quantity: 28; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Lansoprazole ODT
TX
MP NP
C1177 C1337 C1533
P1177
28
1
28
 
 
[88]         Schedule 1, entry for Lansoprazole in the form Tablet 30 mg (orally disintegrating) [Maximum Quantity: 28; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Lansoprazole ODT
TX
MP NP
C1177 C1337 C1533
P1337 P1533
28
5
28
 
 
[89]         Schedule 1, entry for Lansoprazole in the form Tablet 15 mg (orally disintegrating)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Lansoprazole ODT
TX
MP NP
C1337 C1533
 
28
5
28
 
 
[90]         Schedule 1, entry for Methadone in the form Tablet containing methadone hydrochloride 10 mg
omit from the column headed “Circumstances”:        C1358   substitute:             C4953
[91]         Schedule 1, entry for Methadone in the form Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL
[Maximum Quantity: 1; Number of Repeats: 0]
(a)      omit from the column headed “Circumstances”:            C3659  C3660    substitute:          C4902  C4941
(b)      omit from the column headed “Purposes”:       P3660   substitute:          P4941 
[92]         Schedule 1, entry for Methadone in the form Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL
[Maximum Quantity: 1; Number of Repeats: 2]
(a)      omit from the column headed “Circumstances”:            C3659  C3660    substitute:          C4902  C4941
(b)      omit from the column headed “Purposes”:       P3659   substitute:          P4902
[93]         Schedule 1, entry for Methadone in the form Injection containing methadone hydrochloride 10 mg in 1 mL
omit from the column headed “Circumstances”:        C1358   substitute:             C4953
[94]         Schedule 1, entry for Methylprednisolone in the form Powder for injection 1 g (as sodium succinate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Solu-Medrol
PF
MP NP
 
 
1
0
1
 
 
 
[95]         Schedule 1, entry for Metoclopramide in the form Tablet containing metoclopramide hydrochloride 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metoclopramide RBX
RA
MP NP MW PDP
 
 
25
0
25
 
 
[96]         Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metoprolol RBX
RA
MP NP
 
 
100
5
100
 
 
[97]         Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metoprolol RBX
RA
MP NP
 
 
60
5
60
 
 
[98]         Schedule 1, entry for Metronidazole in the form Tablet 400 mg [Maximum Quantity: 21; Number of Repeats: 0]
insert in the column headed “Circumstances” (all instances): C1416  C4932 
[99]         Schedule 1, entry for Metronidazole in the form Tablet 400 mg [Maximum Quantity: 21; Number of Repeats: 1]
(a)      insert in the column headed “Circumstances” (all instances):     C1416  C4932 
(b)      omit from the column headed “Purposes”:       P1416   substitute:          P4932 
[100]       Schedule 1, entry for Minoxidil
omit from the column headed “Circumstances”:        C2759   substitute:             C4906
[101]       Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 10 mg [Maximum Quantity: 20; Number of Repeats: 0]
(a)      omit from the column headed “Circumstances”:            C1789  C3661  C3662    substitute:          C4935  C4948  C4960
(b)      omit from the column headed “Purposes”:       P1789  P3662    substitute:          P4935  P4960
[102]       Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 10 mg [Maximum Quantity: 20; Number of Repeats: 2]
(a)      omit from the column headed “Circumstances”:            C1789  C3661  C3662    substitute:          C4935  C4948  C4960
(b)      omit from the column headed “Purposes”:       P3661   substitute:          P4948
[103]       Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 20 mg [Maximum Quantity: 20; Number of Repeats: 0]
(a)      omit from the column headed “Circumstances”:            C1789  C3661  C3662    substitute:          C4935  C4948  C4960
(b)      omit from the column headed “Purposes”:       P1789  P3662    substitute:          P4935  P4960
[104]       Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 20 mg [Maximum Quantity: 20; Number of Repeats: 2]
(a)      omit from the column headed “Circumstances”:            C1789  C3661  C3662    substitute:          C4935  C4948  C4960
(b)      omit from the column headed “Purposes”:       P3661   substitute:          P4948
[105]       Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 30 mg
omit from the column headed “Circumstances”:          C1358    substitute:             C4926 C4959
[106]       Schedule 1, entry for Morphine in each of the forms: Tablet containing morphine sulfate 5 mg (controlled release); Tablet containing morphine sulfate 10 mg (controlled release); Tablet containing morphine sulfate 15 mg (controlled release); Tablet containing morphine sulfate 30 mg (controlled release); Tablet containing morphine sulfate 60 mg (controlled release); and Tablet containing morphine sulfate 100 mg (controlled release)
omit from the column headed “Circumstances” (all instances):            C1062   substitute:             C4556
[107]       Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 200 mg (controlled release) [Maximum Quantity: 28; Number of Repeats: 0]
(a)      omit from the column headed “Circumstances”:            C1499  C3659  C3660    substitute:          C4900  C4911  C4927
(b)      omit from the column headed “Purposes”:       P1499  P3660    substitute:          P4900  P4927
[108]       Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 200 mg (controlled release) [Maximum Quantity: 28; Number of Repeats: 2]
(a)      omit from the column headed “Circumstances”:            C1499  C3659  C3660    substitute:          C4900  C4911  C4927
(b)      omit from the column headed “Purposes”:       P3659   substitute:          P4911
[109]       Schedule 1, entry for Morphine in each of the forms: Capsule containing morphine sulfate 10 mg (containing sustained release pellets); Capsule containing morphine sulfate 20 mg (containing sustained release pellets); Capsule containing morphine sulfate 30 mg (controlled release); Capsule containing morphine sulfate 50 mg (containing sustained release pellets); Capsule containing morphine sulfate 60 mg (controlled release); Capsule containing morphine sulfate 90 mg (controlled release); Capsule containing morphine sulfate 100 mg (containing sustained release pellets); Capsule containing morphine sulfate 120 mg (controlled release); Sachet containing controlled release granules for oral suspension, containing morphine sulfate 20 mg per sachet; Sachet containing controlled release granules for oral suspension, containing morphine sulfate 30 mg per sachet; Sachet containing controlled release granules for oral suspension, containing morphine sulfate 60 mg per sachet; and Sachet containing controlled release granules for oral suspension, containing morphine sulfate 100 mg per sachet
omit from the column headed “Circumstances”:        C1062   substitute:             C4556
[110]       Schedule 1, entry for Morphine in the form Sachet containing controlled release granules for oral suspension, containing morphine sulfate 200 mg per sachet
omit from the column headed “Circumstances”:        C1499   substitute:             C4900
[111]       Schedule 1, entry for Morphine in each of the forms: Oral solution containing morphine hydrochloride 2 mg per mL, 200 mL; Oral solution containing morphine hydrochloride 5 mg per mL, 200 mL; and Oral solution containing morphine hydrochloride 10 mg per mL, 200 mL
omit from the column headed “Circumstances”:        C1358   substitute:             C4926  C4959
[112]       Schedule 1, entry for Moxonidine in each of the forms: Tablet 200 micrograms; and Tablet 400 micrograms
omit from the column headed “Circumstances”:        C2385   substitute:             C4944
[113]       Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [Maximum Quantity: 4; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ondansetron SZ ODT
HX
MP NP

C3050 C3611 See Note 2
P3050
See Note 2
4
See Note 2
0
See
Note 2
4
 
 
[114]       Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [Maximum Quantity: 10; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ondansetron SZ ODT
HX
MP NP
C3050 C3611
P3611
10
1
10
 
 
[115]       Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [Maximum Quantity: 4; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ondansetron SZ ODT
HX
MP NP

C3050 C3611 See Note 2
P3050
See Note 2
4
See Note 2
0
See
Note 2
4
 
 
[116]       Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [Maximum Quantity: 10; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ondansetron SZ ODT
HX
MP NP
C3050 C3611
P3611
10
1
10
 
 
[117]       Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Maximum Quantity: 4; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ondansetron SZ
HX
MP NP

C3050 C3611 See Note 2
P3050
See Note 2
4
See Note 2
0
See
Note 2
4
 
 
[118]       Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Maximum Quantity: 10; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ondansetron SZ
HX
MP NP
C3050 C3611
P3611
10
1
10
 
 
[119]       Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Maximum Quantity: 4; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ondansetron SZ
HX
MP NP

C3050 C3611 See Note 2
P3050
See Note 2
4
See Note 2
0
See
Note 2
4
 
 
[120]       Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Maximum Quantity: 10; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ondansetron SZ
HX
MP NP
C3050 C3611
P3611
10
1
10
 
 
 
[121]       Schedule 1, entry for Ondansetron in each of the forms: I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL; and I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL
omit:
 
 
 
Ondaz
SZ
MP NP

C3050 C3611
See Note 2
See Note 2
1
See Note 2
0
See
Note 2
1
 
 
[122]       Schedule 1, entry for Oxaliplatin
(a)      omit:
 
Powder for I.V. infusion 50 mg
Injection
Hospira Pty Limited
HH
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
(b)      omit:
 
Powder for I.V. infusion 100 mg
Injection
Hospira Pty Limited
HH
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[123]       Schedule 1, entry for Oxycodone in each of the forms: Tablet containing oxycodone hydrochloride 5 mg; Capsule containing oxycodone hydrochloride 5 mg; Capsule containing oxycodone hydrochloride 10 mg
omit from the column headed “Circumstances”:          C1358    substitute:             C4926  C4959 
[124]       Schedule 1, entry for Oxycodone in the form Capsule containing oxycodone hydrochloride 20 mg
omit from the column headed “Circumstances”:          C1358    substitute:             C4959 
[125]       Schedule 1, entry for Oxycodone in the form Oral solution containing oxycodone hydrochloride 5 mg per 5 mL, 250 mL
omit from the column headed “Circumstances”:        C1358   substitute:             C4926  C4959 
[126]       Schedule 1, entry for Oxycodone in the form Suppository 30 mg (as pectinate)
omit from the column headed “Circumstances”:        C1358   substitute:             C4926  C4959 
[127]       Schedule 1, entry for Oxycodone with naloxone in each of the forms: Tablet (controlled release) containing oxycodone hydrochloride 5 mg with naloxone hydrochloride 2.5 mg; Tablet (controlled release) containing oxycodone hydrochloride 10 mg with naloxone hydrochloride 5 mg; Tablet (controlled release) containing oxycodone hydrochloride 20 mg with naloxone hydrochloride 10 mg; and Tablet (controlled release) containing oxycodone hydrochloride 40 mg with naloxone hydrochloride 20 mg
omit from the column headed “Circumstances”:        C1062   substitute:             C4951
[128]       Schedule 1, entry for Paracetamol in the form Tablet 500 mg
omit from the column headed “Purposes” (all instances):       P2046   substitute:             P4913
[129]       Schedule 1, entry for Paracetamol in the form Tablet 665 mg (modified release) [Maximum Quantity: 192; Number of Repeats: 0]
(a)      omit from the column headed “Circumstances” for the brands “Osteomol 665 Paracetamol” and “Panadol Osteo”:
C2094  C3649  C3650         substitute:          C4940  C4950  C4969
(b)      omit from the column headed “Purposes”:       P3650   substitute:          P4950 
 
[130]       Schedule 1, entry for Paracetamol in the form Tablet 665 mg (modified release) [Maximum Quantity: 192; Number of Repeats: 3]
(a)      omit from the column headed “Circumstances” for the brands “Osteomol 665 Paracetamol” and “Panadol Osteo”:
C2094  C3649  C3650         substitute:          C4940  C4950  C4969
(b)      omit from the column headed “Purposes”:       P3649   substitute:          P4940
[131]       Schedule 1, entry for Paracetamol in the form Tablet 665 mg (modified release) [Maximum Quantity: 192; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances” for the brands “Osteomol 665 Paracetamol” and “Panadol Osteo”:
C2094  C3649  C3650         substitute:          C4940  C4950  C4969
(b)      omit from the column headed “Purposes”:       P2094   substitute:          P4969
[132]       Schedule 1, entry for Paracetamol in the form Suppositories 500 mg, 24 [Maximum Quantity: 4; Number of Repeats: 0]
(a)      omit from the column headed “Circumstances”:               C3649  C3650    substitute:          C4940  C4950
(b)      omit from the column headed “Purposes”:       P3650   substitute:          P4950
[133]       Schedule 1, entry for Paracetamol in the form Suppositories 500 mg, 24 [Maximum Quantity: 4; Number of Repeats: 3]
(a)      omit from the column headed “Circumstances”:               C3649  C3650    substitute:          C4940  C4950
(b)      omit from the column headed “Purposes”:       P3649   substitute:          P4940
[134]       Schedule 1, entry for Paroxetine in the form Tablet 20 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Paroxetine GH
GQ
MP NP
C1211 C1241 C1862
 
30
5
30
 
 
[135]       Schedule 1, entry for Peginterferon beta-1a in the form Pack containing single use injection pens containing 63 micrograms in 0.5 mL and 94 micrograms in 0.5 mL
omit from the column headed “Circumstances”:          C4798    substitute:             C4881
[136]       Schedule 1, entry for Peginterferon beta-1a in the form Single use injection pen containing 125 micrograms in 0.5 mL
[Maximum Quantity: 2; Number of Repeats: 4]
(a)      omit from the column headed “Circumstances”:               C4798  C4811    substitute:          C4881  C4887
(b)      omit from the column headed “Purposes”:       P4798   substitute:          P4881
[137]       Schedule 1, entry for Peginterferon beta-1a in the form Single use injection pen containing 125 micrograms in 0.5 mL
[Maximum Quantity: 2; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:               C4798  C4811    substitute:          C4881  C4887
(b)      omit from the column headed “Purposes”:       P4811   substitute:          P4887
[138]       Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Zabep
AL
MP NP
C1177 C1337 C1533
P1177
30
2
30
 
 
[139]       Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Zabep
AL
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
 
 
[140]       Schedule 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ranitidine GH
GQ
MP NP MW
 
 
60
5
60
 
 
[141]       Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
omit from the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin” [Authorised Prescriber “MP”]:               
P4227  P4259     substitute:             P4226  P4263
[142]       Schedule 1, entry for Salcatonin
omit from the column headed “Circumstances”:        C1412  C3256    substitute:             C4918  C4938
[143]       Schedule 1, entry for Sapropterin in the form Tablet (soluble) containing sapropterin dihydrochloride 100 mg [Maximum Quantity: 180; Number of Repeats: 0]
(a)      omit from the column headed “Circumstances”:            C4547  
(b)      insert in numerical order:     C4921
(c)      omit from the column headed “Purposes”:       P4547   substitute:          P4921
[144]       Schedule 1, entry for Sapropterin in the form Tablet (soluble) containing sapropterin dihydrochloride 100 mg [Maximum Quantity: 180; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:            C4547  
(b)      insert in numerical order:     C4921
[145]       Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 5; Number of Repeats: 5]
omit from the column headed “Form” for the brand “Temozolomide AN” :        f
[146]       Schedule 1, entry for Tiagabine in each of the forms: Tablet 5 mg (as hydrochloride); Tablet 10 mg (as hydrochloride); and Tablet 15 mg (as hydrochloride)
omit from the column headed “Circumstances”:        C2664   substitute:             C4928
[147]       Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 80 mg-12.5 mg
omit:
 
 
 
Dilart HCT 80/12.5
AF
MP NP
C4374
 
28
5
28
 
 
 
[148]       Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 320 mg-12.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Dilart HCT 320/12.5
AF
MP NP
C4361
 
28
5
28
 
 
[149]       Schedule 1, entry for Vigabatrin in each of the forms: Tablet 500 mg; and Oral powder, sachet 500 mg
omit from the column headed “Circumstances”:        C1426   substitute:             C4929 
[150]       Schedule 1, entry for Vitamins, minerals and trace elements with carbohydrate in the form Oral powder 200 g (Paediatric Seravit)
omit from the column headed “Circumstances”:          C3301    substitute:             C4916
[151]       Schedule 1, entry for Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose
omit from the column headed “Circumstances”:        C1596   substitute:             C4322 
[152]       Schedule 3, details relevant to Responsible Persons Code BD
omit:
Biogen Idec Australia Pty Ltd   substitute:             Biogen Australia Pty Ltd
[153]       Schedule 4, Part 1, entry for Abciximab
substitute:

Abciximab
C4915
 
 
Coronary artery disease
Patient must be undergoing percutaneous coronary stent placement
Compliance with Authority Required procedures - Streamlined Authority Code 4915

 
C4942
 
 
Coronary artery disease
Patient must be undergoing percutaneous coronary balloon angioplasty
Compliance with Authority Required procedures - Streamlined Authority Code 4942

 
C4943
 
 
Coronary artery disease
Patient must be undergoing percutaneous coronary atherectomy
Compliance with Authority Required procedures - Streamlined Authority Code 4943

 
[154]       Schedule 4, Part 1, entry for Adapalene with benzoyl peroxide
substitute:

Adapalene with benzoyl peroxide
C4898
P4898
 
Severe acne vulgaris
The treatment must be maintenance therapy
 

 
C4961
P4961
 
Severe acne vulgaris
Acute treatment
The treatment must in combination with an oral antibiotic
 

[155]       Schedule 4, Part 1, entry for Adrenaline
substitute:

Adrenaline
C4909
 
 
Acute allergic reaction with anaphylaxis
Initial sole PBS-subsidised supply for anticipated emergency treatment
Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a clinical immunologist; OR
Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with an allergist; OR
Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a paediatrician; OR
Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a respiratory physician
The name of the specialist consulted must be provided at the time of application for initial supply
Compliance with Authority Required procedures


 
C4946
 
 
Acute allergic reaction with anaphylaxis
Initial sole PBS-subsidised supply for anticipated emergency treatment
Patient must have been discharged from hospital or an emergency department after treatment with adrenaline for acute allergic reaction with anaphylaxis
Compliance with Authority Required procedures


 
C4947
 
 
Acute allergic reaction with anaphylaxis
Continuing sole PBS-subsidised supply for anticipated emergency treatment
Patient must have previously been issued with an authority prescription for this drug
Compliance with Authority Required procedures


[156]       Schedule 4, Part 1, entry for Amino acid formula with vitamins and minerals without phenylalanine
insert in numerical order:
 
C4964
 
 
Phenylketonuria
 
[157]       Schedule 4, Part 1, entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine
insert in numerical order:
 
C4923
 
 
Tyrosinaemia
 
[158]       Schedule 4, Part 1, entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine
insert in numerical order:
 
C4954
 
 
Maple syrup urine disease
 
[159]       Schedule 4, Part 1, after entry for Amylopectin, modified long chain
insert:
Anakinra
C4920
 
 
Moderate to severe cryopyrin associated periodic syndromes (CAPS)
Must be treated by a rheumatologist or in consultation with a rheumatologist
A diagnosis of CAPS must be documented in the patient's medical records
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4920
[160]       Schedule 4, Part 1, entry for Apraclonidine
substitute:
Apraclonidine
C4901
 
 
Intra-ocular pressure
The treatment must be for short-term reduction of intra-ocular pressure; AND
Patient must already be on maximally tolerated anti-glaucoma therapy
 
[161]       Schedule 4, Part 1, entry for Betamethasone
(a)      omit:
 
C1422
 
 
Treatment of corticosteroid‑responsive dermatoses
 
(b)      insert in numerical order after existing text:

 
C4924
 
 
Corticosteroid-responsive dermatoses
 

 
C4957
 
 
Corticosteroid-responsive dermatoses
 

[162]       Schedule 4, Part 1, entry for Bevacizumab
insert in numerical order:

 
C4939
 
 
Metastatic colorectal cancer
Initial treatment
Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must be previously treated with PBS-subsidised first-line anti-EGFR antibodies; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be in combination with second-line chemotherapy; AND
The treatment must not exceed a dose of 5 mg per kg every 2 weeks; OR
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks
Compliance with Authority Required procedures - Streamlined Authority Code 4939


 
C4968
 
 
Metastatic colorectal cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease; AND
The treatment must be in combination with second-line chemotherapy; AND
The treatment must not exceed a dose of 5 mg per kg every 2 weeks; OR
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks
Compliance with Authority Required procedures - Streamlined Authority Code 4968


[163]       Schedule 4, Part 1, entry for Bivalirudin
substitute:
Bivalirudin
C4919
 
 
Coronary artery disease
Patient must be undergoing percutaneous coronary intervention
Compliance with Authority Required procedures - Streamlined Authority Code 4919
[164]       Schedule 4, Part 1, entry for Buprenorphine
substitute:
 
C4951
 
 
Chronic severe disabling pain
The condition must be unresponsive to non-narcotic analgesics
 
[165]       Schedule 4, Part 1, omit entry for Calcipotriol
[166]       Schedule 4, Part 1, entry for Captopril
substitute:
Captopril
C4966
 
 
Patients unable to take a solid dose form of an ACE inhibitor
Patient must not be pregnant. Use of ACE inhibitors is contraindicated during pregnancy since these drugs have been associated with foetal death in utero
 
[167]       Schedule 4, Part 1, entry for Celecoxib
substitute:

Celecoxib
C4907
 
 
Rheumatoid arthritis
The treatment must be for symptomatic treatment
 

 
C4962
 
 
Osteoarthritis
The treatment must be for symptomatic treatment
 

[168]       Schedule 4, Part 1, entry for Cetuximab
(a)      omit:

 
C4771
 
 
Metastatic colorectal cancer
Continuing treatment
Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND
Patient must not have progressive disease; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab
Compliance with Authority Required procedures - Streamlined Authority Code 4771


 
C4779
 
 
Metastatic colorectal cancer
Initial treatment
Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have failed to respond to first-line chemotherapy; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with an irinotecan based therapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab
Compliance with Authority Required procedures - Streamlined Authority Code 4779


(b)      insert in numerical order after existing text:

 
C4908
 
 
Metastatic colorectal cancer
Initial treatment
Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 0 or 1; AND
The condition must be previously untreated; AND
The treatment must be in combination with first-line chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
Compliance with Authority Required procedures - Streamlined Authority Code 4908


 
C4912
 
 
Metastatic colorectal cancer
Continuing treatment
Patient must have received an initial authority prescription for this drug for first-line treatment of RAS wild-type metastatic colorectal cancer; AND
Patient must not have progressive disease; AND
The treatment must be in combination with first-line chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
Compliance with Authority Required procedures - Streamlined Authority Code 4912


 
C4945
 
 
Metastatic colorectal cancer
Continuing treatment
Patient must have received an initial authority prescription for this drug for treatment of RAS wild-type metastatic colorectal cancer after failure of first-line chemotherapy; AND
Patient must not have progressive disease; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab
Compliance with Authority Required procedures - Streamlined Authority Code 4945


 
C4965
 
 
Metastatic colorectal cancer
Initial treatment
Patient must have RAS wild-type metastatic colorectal cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The condition must have failed to respond to first-line chemotherapy; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with chemotherapy; AND
The treatment must be the sole PBS-subsidised anti-EGFR antibody therapy for this condition
Patients who have progressive disease on panitumumab are not eligible to receive PBS-subsidised cetuximab
Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised cetuximab
Compliance with Authority Required procedures - Streamlined Authority Code 4965


[169]       Schedule 4, Part 1, entry for Clodronic Acid
substitute:

Clodronic acid
C4933
 
 
Bone metastases
The condition must be due to breast cancer
 

 
C4955
 
 
Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti-neoplastic therapy
 

 
C4956
 
 
Multiple myeloma
 

[170]       Schedule 4, Part 1, entry for Codeine with Paracetamol
substitute:
Codeine with paracetamol
 
P4903
CN4903
Severe disabling pain
The condition must be unresponsive to non-narcotic analgesics
Compliance with Authority Required procedures
[171]       Schedule 4, Part 1, entry for Dalteparin
substitute:

Dalteparin
 
P4910
 
Haemodialysis
 

 
C4967
P4967
 
Symptomatic venous thromboembolism
Management
Patient must have a solid tumour(s)
 

[172]       Schedule 4, Part 1, entry for Enoxaparin
insert in numerical order:
 
 
P4910
 
Haemodialysis
 
[173]       Schedule 4, Part 1, entry for Eplerenone
substitute:
Eplerenone
C4937
 
 
Heart failure with a left ventricular ejection fraction of 40% or less
The condition must occur within 3 to 14 days following an acute myocardial infarction; AND
The treatment must be commenced within 14 days of an acute myocardial infarction
The date of the acute myocardial infarction and the date of initiation of treatment with this drug must be documented in the patient's medical records when PBS-subsidised treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4937
 
[174]       Schedule 4, Part 1, entry for Essential amino acids formula
(a)      omit from the column headed “Circumstances Code”:     C1147    substitute:             C4925
(b)      omit from the column headed “Circumstances Code”:     C1458    substitute:             C4958
[175]       Schedule 4, Part 1, entry for Essential amino acids formula with minerals and vitamin C
(a)      omit from the column headed “Circumstances Code”:     C1147    substitute:             C4925
(b)      omit from the column headed “Circumstances Code”:     C1458    substitute:             C4958
[176]       Schedule 4, Part 1, entry for Essential amino acids formula with vitamins and minerals
(a)      omit from the column headed “Circumstances Code”:     C1147    substitute:             C4925
(b)      omit from the column headed “Circumstances Code”:     C1458    substitute:             C4958
[177]       Schedule 4, Part 1, entry for Ethacrynic Acid
omit from the column headed “Circumstances Code”:               C1261    substitute:             C4936
[178]       Schedule 4, Part 1, entry for Fentanyl
(a)      omit:
 
C1062
 
 
Chronic severe disabling pain not responding to non‑narcotic analgesics
 
(b)      omit:
 
C4267
P4267
 
Breakthrough pain
Continuing treatment
Patient must be undergoing palliative care;
Patient must have cancer;
Patient must be receiving opioids for their persistent pain;
Patient must be unable to tolerate further escalation in the dose of morphine for breakthrough pain due to adverse effects
Compliance with Authority Required procedures
(c)      insert in numerical order after existing text:

 
C4914
 
 
Breakthrough pain
Continuing treatment
Patient must have cancer; AND
Patient must be receiving opioids for their persistent pain; AND
Patient must be unable to tolerate further escalation in the dose of morphine for breakthrough pain due to adverse effects
Patient must be undergoing palliative care
Compliance with Authority Required procedures


 
C4952
 
 
Chronic severe disabling pain
The condition must be unresponsive to non-narcotic analgesics
 

[179]       Schedule 4, Part 1, entry for Fluticasone with Salmeterol
(a)      omit:
 
C4408
 
 
Asthma
Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids;
Patient must have been stabilised on concomitant inhaled salmeterol xinafoate and fluticasone propionate if aged less than 12 years
 
(b)      insert in numerical order after existing text:
 
C4930
 
 
Asthma
Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids
Patient must be aged 4 years or older
 
[180]       Schedule 4, Part 1, entry for Fusidic Acid
substitute:
Fusidic acid
C4963
 
 
Serious staphylococcal infections
The treatment must be used in combination with another antibiotic; AND
The condition must be proven to be due to a staphylococcus
 
[181]       Schedule 4, Part 1, entry for Hydrocortisone
(a)      omit:
 
C1422
 
 
Treatment of corticosteroid‑responsive dermatoses
 
(b)      insert in numerical order after existing text:

 
C4899
P4899
 
Corticosteroid-responsive dermatoses
 

 
C4934
P4934
 
Corticosteroid-responsive dermatoses
 

[182]       Schedule 4, Part 1, entry for Hydromorphone
substitute:

Hydromorphone
C4556
 
 
Chronic severe disabling pain
The condition must be unresponsive to non-narcotic analgesics
 

 
C4926
 
 
Severe disabling pain
The condition must be unresponsive to non-narcotic analgesics
 

 
C4959
 
 
Severe disabling pain
The condition must be unresponsive to non-narcotic analgesics
 

[183]       Schedule 4, Part 1, entry for Ibandronic acid
insert in numerical order:
 
C4922
 
 
Bone metastases
The condition must be due to breast cancer
 
[184]       Schedule 4, Part 1, entry for Icatibant
substitute:

Icatibant
C4917
 
 
Anticipated emergency treatment of an acute attack of hereditary angioedema
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug
Compliance with Authority Required procedures

 
C4949
 
 
Anticipated emergency treatment of an acute attack of hereditary angioedema
Initial treatment
Patient must have confirmed diagnosis of C1-esterase inhibitor deficiency; AND
Patient must have been assessed to be at significant risk of an acute attack of hereditary angioedema; AND
The condition must be assessed by a clinical immunologist; OR
The condition must be assessed by a respiratory physician; OR
The condition must be assessed by a specialist allergist; OR
The condition must be assessed by a general physician experienced in the management of patients with hereditary angioedema
The name of the specialist consulted must be provided at the time of application for initial supply
The date of the pathology report and name of the Approved Pathology Authority must be provided at the time of application
Compliance with Authority Required procedures


[185]       Schedule 4, Part 1, entry for Methadone
substitute:

Methadone
C4902
 
 
Chronic severe disabling pain
Initial treatment, for up to 3 months
Patient must be receiving palliative care; AND
The condition must be unresponsive to non-narcotic analgesics
Compliance with Authority Required procedures


 
C4941
 
 
Chronic severe disabling pain
Continuing treatment
Patient must be receiving palliative care; AND
The condition must be unresponsive to non-narcotic analgesics
Compliance with Authority Required procedures


 
C4953
 
 
Severe disabling pain
The condition must be unresponsive to non-narcotic analgesics
 

[186]       Schedule 4, Part 1, entry for Metronidazole [Purposes Code P1416]
insert in the column headed: “Circumstances Code”:                C1416
[187]       Schedule 4, Part 1, entry for Metronidazole
insert in numerical order:
 
C4932
P4932
 
Infection
The condition must be due to anaerobic bacteria
 
[188]       Schedule 4, Part 1, entry for Minoxidil
substitute:
Minoxidil
C4906
 
 
Severe refractory hypertension
The treatment must be initiated by a consultant physician
Compliance with Authority Required procedures - Streamlined Authority Code 4906
[189]       Schedule 4, Part 1, entry for Morphine
substitute:

Morphine
C4556
 
 
Chronic severe disabling pain
The condition must be unresponsive to non-narcotic analgesics
 

 
C4900
P4900
 
Chronic severe disabling pain
The condition must be due to cancer; AND
The condition must be unresponsive to non-narcotic analgesics
Compliance with Authority Required procedures

 
C4911
P4911
 
Chronic severe disabling pain
Initial treatment, for up to 3 months
Patient must be receiving palliative care; AND
The condition must be unresponsive to non-narcotic analgesics
Compliance with Authority Required procedures

 
C4926
 
 
Severe disabling pain
The condition must be unresponsive to non-narcotic analgesics
 

 
C4927
P4927
 
Chronic severe disabling pain
Continuing treatment
Patient must be receiving palliative care; AND
The condition must be unresponsive to non-narcotic analgesics
Compliance with Authority Required procedures

 
C4935
P4935
 
Severe disabling pain
Continuing treatment
Patient must be receiving palliative care; AND
The condition must be unresponsive to non-narcotic analgesics
Compliance with Authority Required procedures


 
C4948
P4948
 
Severe disabling pain
Initial treatment, for up to 3 months
Patient must be receiving palliative care; AND
The condition must be unresponsive to non-narcotic analgesics
Compliance with Authority Required procedures


 
C4959
 
 
Severe disabling pain
The condition must be unresponsive to non-narcotic analgesics
 

 
C4960
P4960
 
Severe disabling pain
The condition must be due to cancer; AND
The condition must be unresponsive to non-narcotic analgesics
 

[190]       Schedule 4, Part 1, entry for Moxonidine
substitute:
Moxonidine
C4944
 
 
Hypertension
Patient must be receiving concurrent antihypertensive therapy
 
[191]       Schedule 4, Part 1, entry for Oxycodone
(a)      omit:
 
C1358
 
 
Severe disabling pain not responding to non‑narcotic analgesics
 
(b)      insert in numerical order after existing text:

 
C4926
 
 
Severe disabling pain
The condition must be unresponsive to non-narcotic analgesics
 

 
C4959
 
 
Severe disabling pain
The condition must be unresponsive to non-narcotic analgesics
 

[192]       Schedule 4, Part 1, entry for Oxycodone with naloxone
substitute:
Oxycodone with naloxone
C4951
 
 
Chronic severe disabling pain
The condition must be unresponsive to non-narcotic analgesics
 
[193]       Schedule 4, Part 1, entry for Paracetamol
substitute:

Paracetamol
 
P4913
 
Chronic arthropathies
 

 
C4940
P4940
 
Analgesia or fever
Initial treatment, for up to 4 months
Patient must be receiving palliative care; AND
Patient must be intolerant to alternative therapy
Compliance with Authority Required procedures - Streamlined Authority Code 4940

 
C4950
P4950
 
Analgesia or fever
Continuing treatment
Patient must be receiving palliative care; AND
Patient must be intolerant to alternative therapy
Compliance with Authority Required procedures - Streamlined Authority Code 4950

 
C4969
P4969
 
Persistent pain
The condition must be associated with osteoarthritis
 

[194]       Schedule 4, Part 1, entry for Peginterferon beta-1a
substitute:

Peginterferon beta-1a
C4881
P4881
 
Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis, with written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND
Patient must be ambulatory (without assistance or support)
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records
Compliance with Authority Required procedures - Streamlined Authority Code 4881


 
C4887
P4887
 
Multiple sclerosis
Continuing treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy
Compliance with Authority Required procedures - Streamlined Authority Code 4887


[195]       Schedule 4, Part 1, entry for Salcatonin
substitute:

Salcatonin
C4918
 
 
Hypercalcaemia
The treatment must be initiated in a hospital
Compliance with Authority Required procedures - Streamlined Authority Code 4918

 
C4938
 
 
Symptomatic Paget disease of bone

Compliance with Authority Required procedures - Streamlined Authority Code 4938

[196]       Schedule 4, Part 1, entry for Sapropterin
(a)      omit:
 
C4547
P4547
 
Hyperphenylalaninaemia
Initial treatment
Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency
Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured
The authority application must be made in writing
Compliance with Written Authority Required procedures
(b)      insert in numerical order after existing text:
 
C4921
P4921
 
Hyperphenylalaninaemia
Initial treatment
Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency
Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured
The authority application must be made in writing
Compliance with Written Authority Required procedures

[197]       Schedule 4, Part 1, entry for Tiagabine
substitute:
Tiagabine
C4928
 
 
Partial epileptic seizures
The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs
Compliance with Authority Required procedures - Streamlined Authority Code 4928
[198]       Schedule 4, Part 1, entry for Vigabatrin
substitute:
Vigabatrin
C4929
 
 
Epileptic seizures
The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs
Compliance with Authority Required procedures - Streamlined Authority Code 4929
[199]       Schedule 4, Part 1, entry for Vitamins, minerals and trace elements with carbohydrate
(a)      omit:
 
C3301
 
 
Infants and children whose vitamin and mineral intake is insufficient due to a specific diagnosis requiring a highly restrictive therapeutic diet, and whose vitamin, mineral and trace element needs cannot be adequately met with other proprietary vitamin and mineral preparations
Compliance with Authority Required procedures
(b)      insert in numerical order after existing text:
 
C4916
 
 
Dietary management of conditions requiring a highly restrictive therapeutic diet
Patient must have insufficient vitamin and mineral intake due to a specific diagnosis requiring a highly restrictive therapeutic diet; AND
Patient must be unable to adequately meet vitamin, mineral and trace element needs with other proprietary vitamin and mineral preparations
Patient must be an infant or a child
Compliance with Authority Required procedures

[200]       Schedule 4, Part 1, entry for Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose
substitute:
Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose
C4322
 
 
Chronic renal failure
Patient must require treatment with a low protein and a low phosphorus diet; OR
Patient must require treatment with a low protein, low phosphorus and low potassium diet
Patient must be an infant or a young child
Compliance with Authority Required procedures

 
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