National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 8) (PB 52 of 2014)

Link to law: https://www.comlaw.gov.au/Details/F2014L01058

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PB 52 of 2014
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 8)
National Health Act 1953
I, PAUL CREECH, First Assistant Secretary (Acting), 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 14 JULY 2014
 
 
 
 
 
 
 
 
 
 
 
PAUL CREECH
First Assistant Secretary (Acting)
Pharmaceutical Benefits Division
Department of Health
 
1          Name of Instrument
            (1)        This Instrument is the National Health (Listing of Pharmaceutical                            Benefits) Amendment Instrument 2014 (No. 8).
            (2)        This Instrument may also be cited as PB 52 of 2014.
2          Commencement
This Instrument commences on 1 August 2014.
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, after entry for Acitretin in the form Capsule 25 mg [Brand: Novatin]
insert:
Aclidinium
Powder for oral inhalation in breath actuated device containing aclidinium bromide 400 micrograms per dose, 60 doses
Inhalation by mouth
Bretaris Genuair
FK
MP NP
C4516
 
1
5
1
 
 
[2]           Schedule 1, entry for Alprazolam in each of the forms: Tablet 250 micrograms; and Tablet 500 micrograms
omit:
 
 
 
Alprazolam Sandoz
SZ
MP NP
C1975
 
50
0
50
 
[3]           Schedule 1, entry for Alprazolam in each of the forms: Tablet 1 mg; and Tablet 2 mg
omit:
 
 
 
Alprazolam Sandoz
SZ
MP NP
C1975
 
50
2
50
 
[4]           Schedule 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 100 mg
omit:
 
 
 
Amiodarone Sandoz
SZ
MP NP
C1350
 
30
5
30
 
[5]           Schedule 1, entry for Atomoxetine in each of the forms: Capsule 10 mg (as hydrochloride); Capsule 18 mg (as hydrochloride);
Capsule 25 mg (as hydrochloride); Capsule 40 mg (as hydrochloride); Capsule 60 mg (as hydrochloride); Capsule 80 mg (as hydrochloride); and Capsule 100 mg (as hydrochloride)
omit from the column headed “Circumstances”:          C3025  C3026  C3027  C3028       substitute:             C4578  C4591
[6]           Schedule 1, after entry for Benzylpenicillin in the form Powder for injection 3 g (as sodium)
insert:
Betaine
Oral powder 180 g
Oral
Cystadane
EU
MP
C4599
 
1
5
1
 
 
[7]           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
omit from the column headed “Circumstances”:          C3430  C3431  C3894  C3896      
substitute:             C4584  C4585  C4587  C4588  C4589  C4594  C4597  C4598
 
[8]           Schedule 1, entry for Calcium in the form Tablet, chewable, 500 mg (as carbonate)
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cal‑500
PP
MP NP
C4586
 
240
1
60
 
 
(b)      omit from the column headed “Circumstances” for the brand “Cal-Sup”:  C2212    substitute:             C4586
[9]           Schedule 1, entry for Calcium in the form Tablet 600 mg (as carbonate)
omit from the column headed “Circumstances”:          C2212    substitute:             C4586
[10]         Schedule 1, entry for Capecitabine
substitute:
Capecitabine
Tablet 150 mg
Oral
Capecitabine Actavis
GN
MP
C1522 C1614 C1738 C1739 C3509 C3942
 
60
2
60
 
 

 
 
 
Capecitabine Alphapharm
AF
MP
C1522 C1614 C1738 C1739 C3509 C3942
 
60
2
60
 
 

 
 
 
Capecitabine-DRLA
RZ
MP
C1522 C1614 C1738 C1739 C3509 C3942
 
60
2
60
 
 

 
 
 
Capecitabine Sandoz
SZ
MP
C1522 C1614 C1738 C1739 C3509 C3942
 
60
2
60
 
 

 
 
 
Xeloda
RO
MP
C1522 C1614 C1738 C1739 C3509 C3942
 
60
2
60
 
 

 
Tablet 500 mg
Oral
Capecitabine Actavis
GN
MP
C1522 C1614 C1738 C1739 C3509 C3942
 
120
2
120
 
 

 
 
 
Capecitabine Alphapharm
AF
MP
C1522 C1614 C1738 C1739 C3509 C3942
 
120
2
120
 
 

 
 
 
Capecitabine Apotex
TX
MP
C1522 C1614 C1738 C1739 C3509 C3942
 
120
2
120
 
 

 
 
 
Capecitabine-DRLA
RZ
MP
C1522 C1614 C1738 C1739 C3509 C3942
 
120
2
120
 
 

 
 
 
Capecitabine GH
GQ
MP
C1522 C1614 C1738 C1739 C3509 C3942
 
120
2
120
 
 

 
 
 
Capecitabine Sandoz
SZ
MP
C1522 C1614 C1738 C1739 C3509 C3942
 
120
2
120
 
 

 
 
 
Xeloda
RO
MP
C1522 C1614 C1738 C1739 C3509 C3942
 
120
2
120
 
 

[11]         Schedule 1, entry for Captopril in each of the forms: Tablet 12.5 mg; Tablet 25 mg; and Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Captopril
TX
MP NP
 
 
90
5
90
 
 
[12]         Schedule 1, entry for Carboplatin in the form Solution for I.V. injection 450 mg in 45 mL
omit:
 
 
 
Carbaccord
GN
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[13]         Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Maximum Quantity: 100;
Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cyrotone
ER
MP
C1014 C1230 C1404
P1014 P1404
100
5
50
 
 
[14]         Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; Tablet containing enalapril maleate 10 mg; and Tablet containing enalapril maleate 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Malean
FM
MP NP
 
 
30
5
30
 
 
[15]         Schedule 1, entry for Epirubicin in each of the forms: Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL; Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL; Solution for injection containing epirubicin hydrochloride 50 mg in
25 mL; and Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL
omit:
 
 
 
Epiccord
GN
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[16]         Schedule 1, after entry for Epoprostenol in the form Powder for I.V. infusion, 500 micrograms (as sodium) infusion administration set
insert in the columns in the order indicated:
 
Powder for I.V. infusion 500 micrograms (as sodium)
Injection
Veletri
AT
MP
See Note 1
See Note 3
See Note 3
See Note 3
See
Note 3
1
 
D(100)
[17]         Schedule 1, after entry for Epoprostenol in the form Powder for I.V. infusion, 1.5 mg (as sodium) infusion administration set
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
Powder for I.V. infusion 1.5 mg (as sodium)
Injection
Veletri
AT
MP
See Note 1
See Note 3
See Note 3
See Note 3
See
Note 3
1
 
D(100)
[18]         Schedule 1, entry for Erlotinib in each of the forms: Tablet 25 mg (as hydrochloride); Tablet 100 mg (as hydrochloride); and Tablet 150 mg (as hydrochloride)
(a)      omit from the column headed “Circumstances”:               C4481  C4525  C4536     
(b)      insert in numerical order:       C4600
[19]         Schedule 1, entry for Esomeprazole
substitute:
Esomeprazole
Tablet (enteric coated) 20 mg (as magnesium trihydrate)
Oral
Esomeprazole RBX
RA
MP NP
C1337 C1629 C2273 C3429
P2273
30
1
30
 
 

 
 
 
Nexium
AP
MP NP
C1337 C1629 C2273 C3429
P2273
30
1
30
 
 

 
 
 
Esomeprazole RBX
RA
MP NP
C1337 C1629 C2273 C3429
P1337 P1629 P3429
30
5
30
 
 

 
 
 
Nexium
AP
MP NP
C1337 C1629 C2273 C3429
P1337 P1629 P3429
30
5
30
 
 

 
Tablet (enteric coated) 40 mg (as magnesium trihydrate)
Oral
Esomeprazole RBX
RA
MP NP
C1337 C1628 C3429
P1628
30
1
30
 
 

 
 
 
Nexium
AP
MP NP
C1337 C1628 C3429
P1628
30
1
30
 
 

 
 
 
Esomeprazole RBX
RA
MP NP
C1337 C1628 C3429
P1337 P3429
30
5
30
 
 

 
 
 
Nexium
AP
MP NP
C1337 C1628 C3429
P1337 P3429
30
5
30
 
 

[20]         Schedule 1, entry for Fondaparinux
omit from the column headed “Responsible Person”:                 GK          substitute:             AS
[21]         Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride)
(a)      omit:
 
 
 
Gemcitabine Actavis
GN
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
(b)      omit:
 
 
 
Gemplan
GN
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[22]         Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride)
omit:
 
 
 
Gemplan
GN
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
 
[23]         Schedule 1, entry for Irbesartan in the form Tablet 75 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irprestan 75
ZP
MP NP
 
 
30
5
30
 
 
[24]         Schedule 1, entry for Irbesartan in the form Tablet 150 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irprestan 150
ZP
MP NP
 
 
30
5
30
 
 
[25]         Schedule 1, entry for Irbesartan in the form Tablet 300 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irprestan 300
ZP
MP NP
 
 
30
5
30
 
 
[26]         Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 150 mg-12.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irbesartan HCT Actavis 150/12.5
UA
MP NP
C4374
 
30
5
30
 
 
[27]         Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irbesartan HCT Actavis 300/25
UA
MP NP
C4374
 
30
5
30
 
 
[28]         Schedule 1, entry for Levetiracetam in the form Tablet 250 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Levi 250
FM
MP NP
C2664
 
60
5
60
 
 
[29]         Schedule 1, entry for Levetiracetam in the form Tablet 500 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Levi 500
FM
MP NP
C2664
 
60
5
60
 
 
[30]         Schedule 1, entry for Levetiracetam in the form Tablet 1 g
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Levi 1000
FM
MP NP
C2664
 
60
5
60
 
 
 
[31]         Schedule 1, entry for Macrogol 3350
insert as first item in the columns in the order indicated:
 
Oral liquid 13.125 g with electrolytes, 500 mL
Oral
Movicol Liquid
NE
MP NP
C4576 C4577 C4580 C4590 C4595 C4596 C4601
P4590
2
0
1
 
 

 
 
 
 
 
MP NP
C4576 C4577 C4580 C4590 C4595 C4596 C4601
P4595
2
3
1
 
 

 
 
 
 
 
MP NP
C4576 C4577 C4580 C4590 C4595 C4596 C4601
P4576 P4577 P4580 P4596 P4601
2
5
1
 
 

[32]         Schedule 1, entry for Macrogol 3350
omit:
 
Sachets containing powder for oral solution 13.125 g with electrolytes, 30
Oral
APO‑MACROGOL plus ELECTROLYTES
TX
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3643
See Note 2
2
See Note 2
0
See
Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3642
See Note 2
2
See Note 2
3
See
Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P1263 P1613 P2693 P2823
See Note 2
1
See Note 2
5
See
Note 2
1
 
 

 
 
 
LaxaCon
GN
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3643
See Note 2
2
See Note 2
0
See
Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3642
See Note 2
2
See Note 2
3
See
Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P1263 P1613 P2693 P2823
See Note 2
1
See Note 2
5
See
Note 2
1
 
 

 
 
 
lax‑sachets
AE
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3643
See Note 2
2
See Note 2
0
See
Note 2
1
 
 

 
 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3642
See Note 2
2
See Note 2
3
See
Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P1263 P1613 P2693 P2823
See Note 2
1
See Note 2
5
See
Note 2
1
 
 

 
 
 
Molaxole
HM
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3643
See Note 2
2
See Note 2
0
See
Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3642
See Note 2
2
See Note 2
3
See
Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P1263 P1613 P2693 P2823
See Note 2
1
See Note 2
5
See
Note 2
1
 
 

 
 
 
Movicol
NE
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3643
See Note 2
2
See Note 2
0
See
Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3642
See Note 2
2
See Note 2
3
See
Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P1263 P1613 P2693 P2823
See Note 2
1
See Note 2
5
See
Note 2
1
 
 

substitute:
 
Sachets containing powder for oral solution 13.125 g with electrolytes, 30
Oral
APO-MACROGOL plus ELECTROLYTES
TX
MP NP
See Note 1
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4576 P4577 P4580 P4596 P4601
See Note 2
1
See Note 2
5
See
Note 2
1
 
 

 
 
 
LaxaCon
GN
MP NP
See Note 1
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4576 P4577 P4580 P4596 P4601
See Note 2
1
See Note 2
5
See
Note 2
1
 
 

 
 
 
 
lax-sachets
AE
MP NP
See Note 1
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4576 P4577 P4580 P4596 P4601
See Note 2
1
See Note 2
5
See
Note 2
1
 
 

 
 
 
Molaxole
HM
MP NP
See Note 1
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4576 P4577 P4580 P4596 P4601
See Note 2
1
See Note 2
5
See
Note 2
1
 
 

 
 
 
Movicol
NE
MP NP
See Note 1
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4576 P4577 P4580 P4596 P4601
See Note 2
1
See Note 2
5
See
Note 2
1
 
 

 
 
 
APO-MACROGOL plus ELECTROLYTES
TX
MP NP
See Note 1
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4590
See Note 2
2
See Note 2
0
See
Note 2
1
 
 

 
 
 
LaxaCon
GN
MP NP
See Note 1
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4590
See Note 2
2
See Note 2
0
See
Note 2
1
 
 

 
 
 
lax-sachets
AE
MP NP
See Note 1
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4590
See Note 2
2
See Note 2
0
See
Note 2
1
 
 

 
 
 
Molaxole
HM
MP NP
See Note 1
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4590
See Note 2
2
See Note 2
0
See
Note 2
1
 
 

 
 
 
Movicol
NE
MP NP
See Note 1
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4590
See Note 2
2
See Note 2
0
See
Note 2
1
 
 

 
 
 
APO-MACROGOL plus ELECTROLYTES
TX
MP NP
See Note 1
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4595
See Note 2
2
See Note 2
3
See
Note 2
1
 
 

 
 
 
 
LaxaCon
GN
MP NP
See Note 1
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4595
See Note 2
2
See Note 2
3
See
Note 2
1
 
 

 
 
 
lax-sachets
AE
MP NP
See Note 1
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4595
See Note 2
2
See Note 2
3
See
Note 2
1
 
 

 
 
 
Molaxole
HM
MP NP
See Note 1
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4595
See Note 2
2
See Note 2
3
See
Note 2
1
 
 

 
 
 
Movicol
NE
MP NP
See Note 1
C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2
P4595
See Note 2
2
See Note 2
3
See
Note 2
1
 
 

[33]         Schedule 1, entry for Metoprolol succinate in the form Tablet 23.75 mg (controlled release)
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metrol-XL 23.75
QA
MP NP
C3234
 
15
0
15
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Minax XL
AF
MP NP
C3234
 
15
0
15
 
 
[34]         Schedule 1, entry for Metoprolol succinate in the form Tablet 47.5 mg (controlled release)
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metrol-XL 47.5
QA
MP NP
C3234
 
30
5
30
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Minax XL
AF
MP NP
C3234
 
30
5
30
 
 
[35]         Schedule 1, entry for Metoprolol succinate in the form Tablet 95 mg (controlled release)
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metrol-XL 95
QA
MP NP
C3234
 
30
5
30
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Minax XL
AF
MP NP
C3234
 
30
5
30
 
 
 
[36]         Schedule 1, entry for Metoprolol succinate in the form Tablet 190 mg (controlled release)
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metrol-XL 190
QA
MP NP
C3234
 
30
5
30
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Minax XL
AF
MP NP
C3234
 
30
5
30
 
 
[37]         Schedule 1, entry for Metronidazole
omit:
 
I.V. infusion 500 mg in 100 mL
Injection
Baxter Healthcare Pty Ltd
BX
MP NP
C4167 C4168 C4169
 
10
0
1
 
 

 
 
 
 
 
PDP
C4169
 
10
0
1
 
 

 
 
 
DBL Metronidazole Intravenous Infusion
HH
MP NP
C4167 C4168 C4169
 
10
0
10
 
 

 
 
 
 
 
PDP
C4169
 
10
0
10
 
 

 
 
 
Metronidazole‑
Claris
AE
MP NP
C4167 C4168 C4169
 
10
0
5
 
 

 
 
 
 
 
PDP
C4169
 
10
0
5
 
 

 
 
 
Metronidazole Sandoz IV
SZ
MP NP
C4167 C4168 C4169
 
10
0
10
 
 

 
 
 
 
 
PDP
C4169
 
10
0
10
 
 

substitute:
 
I.V. infusion 500 mg in 100 mL
Injection
DBL Metronidazole Intravenous Infusion
HH
MP NP
C4592 C4593
 
10
0
5
 
 

 
 
 
 
 
PDP
C4581
 
10
0
5
 
 

 
 
 
Metronidazole‑
Claris
AE
MP NP
C4592 C4593
 
10
0
10
 
 

 
 
 
 
 
PDP
C4581
 
10
0
10
 
 

 
 
 
Metronidazole Sandoz IV
SZ
MP NP
C4592 C4593
 
10
0
10
 
 

 
 
 
 
 
PDP
C4581
 
10
0
10
 
 

[38]         Schedule 1, entry for Norethisterone in the form Tablets 350 micrograms, 28
omit:
 
 
 
Locilan 28 Day
FZ
MP NP
 
4
2
4
 
[39]         Schedule 1, entry for Omalizumab
substitute:
Omalizumab
Injection 75 mg in 0.5 mL single dose pre-filled syringe
Injection
Xolair
NV
MP
See Note 1
See Note 3
See Note 3
See Note 3
See
Note 3
1
 
D(100)

 
Injection 150 mg in 1 mL single dose pre-filled syringe
Injection
Xolair
NV
MP
See Note 1
See Note 3
See Note 3
See Note 3
See
Note 3
1
 
D(100)

 
Powder for injection 150 mg with diluent
Injection
Xolair
NV
MP
See Note 1
See Note 3
See Note 3
See Note 3
See
Note 3
1
 
D(100)

[40]         Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 50 mg
omit:
 
 
 
Xalox
GN
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[41]         Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 100 mg
omit:
 
 
 
Xalox
GN
MP
 
 
See Note 3
S See
Note 3
1
 
D(100)
[42]         Schedule 1, after entry for Panitumumab in the form Solution concentrate for I.V. infusion 100 mg in 5 mL
insert in the columns in the order indicated:
 
Solution concentrate for I.V. infusion 400 mg in 20 mL
Injection
Vectibix
AN
MP
C4462 C4498 C4530 C4543
See Note 3
See Note 3
See
Note 3
1
D(100)
[43]         Schedule 1, after entry for Progesterone in the form Vaginal gel (prolonged release) 90 mg in single dose pre‑filled applicator
insert in the columns in the order indicated:
 
Vaginal tablet 100 mg
Vaginal
Endometrin
FP
MP
See Note 1
See Note 3
See Note 3
See Note 3
See
Note 3
1
D(100)
[44]         Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Quetia 25
FM
MP NP
C4385 C4391 C4396
 
60
0
60
 
 
[45]         Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Quetia 100
FM
MP NP
C1589 C2044 C2765
 
90
5
90
 
 
[46]         Schedule 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Quetia 200
FM
MP NP
C1589 C2044 C2765
 
60
5
60
 
 
[47]         Schedule 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Quetia 300
FM
MP NP
C1589 C2044 C2765
 
60
5
60
 
 
[48]         Schedule 1, entry for Saxagliptin
insert as first item in the columns in the order indicated:
 
Tablet 2.5 mg (as hydrochloride)
Oral
Onglyza
AP
MP NP
C4520
 
28
5
28
 
 
[49]         Schedule 1, entry for Sildenafil
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Sildenafil PHT
TX
MP
See Note 1
See Note 3
See Note 3
See Note 3
See
Note 3
90
 
D(100)
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Sildenafil Sandoz PHT 20
SZ
MP
See Note 1
See Note 3
See Note 3
See Note 3
See
Note 3
90
 
D(100)
[50]         Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg [Maximum Quantity: 100; Number of Repeats: 3]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Tacrolimus 0.5
CR
MP
C3080
 
100
3
100
 
 
[51]         Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg [Maximum Quantity: 200; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Tacrolimus 0.5
CR
MP
See Note 1
C1654 C3328
 
200
5
100
 
C(100)
[52]         Schedule 1, entry for Tacrolimus in the form Capsule 1 mg [Maximum Quantity: 100; Number of Repeats: 3]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Tacrolimus 1
CR
MP
C3080
 
100
3
100
 
 
[53]         Schedule 1, entry for Tacrolimus in the form Capsule 1 mg [Maximum Quantity: 200; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Tacrolimus 1
CR
MP
See Note 1
C1654 C3328
 
200
5
100
 
C(100)
[54]         Schedule 1, entry for Tacrolimus in the form Capsule 5 mg [Maximum Quantity: 50; Number of Repeats: 3]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Tacrolimus 5
CR
MP
C3080
 
50
3
50
 
 
[55]         Schedule 1, entry for Tacrolimus in the form Capsule 5 mg [Maximum Quantity: 100; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Tacrolimus 5
CR
MP
See Note 1
C1654 C3328
 
100
5
50
 
C(100)
[56]         Schedule 1, entry for Ticarcillin with Clavulanic Acid
omit from the column headed “Pack Quantity” (twice occurring):          10           substitute:             1
[57]         Schedule 1, entry for Tirofiban
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Tirofiban AC
GN
MP NP
C1275 C1729 C1730
 
1
2
1
 
 
[58]         Schedule 1, entry for Vancomycin in the form Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)
(a)      omit:
 
 
 
Vycin IV
GN
MP
C1091 C1302 C1464
P1302
2
0
1
 
 

 
 
 
 
 
PDP
C1302
 
2
0
1
 
 

(b)      omit:
 
 
 
Vycin IV
GN
MP
C1091 C1302 C1464
P1091 P1464
5
0
1
 
 
 
[59]         Schedule 3, after details relevant to Responsible Person code ER
insert:
EU
Emerge Health Pty Ltd
 72 145 180 865
[60]         Schedule 4, Part 1, after entry for Acitretin
insert:
Aclidinium
C4516
 
 
Chronic obstructive pulmonary disease (COPD)
 
[61]         Schedule 4, Part 1, entry for Atomoxetine
substitute:

Atomoxetine
C4578
 
 
Attention deficit hyperactivity disorder
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug
Compliance with Authority Required procedures - Streamlined Authority Code 4578

 
C4591
 
 
Attention deficit hyperactivity disorder
Initial treatment
The condition must be or have been diagnosed by a paediatrician or psychiatrist according to the DSM-5 criteria; AND
Patient must have a contraindication to dexamphetamine or methylphenidate as specified in TGA-approved product information; OR
Patient must have a comorbid mood disorder that has developed or worsened as a result of dexamphetamine or methylphenidate treatment and is of a severity necessitating treatment withdrawal; OR
Patient must be at an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal if given a stimulant treatment with another agent; OR
Patient must have experienced adverse reactions of a severity necessitating permanent treatment withdrawal following treatment with dexamphetamine and treatment with methylphenidate (not simultaneously)
Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive
Compliance with Authority Required procedures - Streamlined Authority Code 4591


[62]         Schedule 4, Part 1, after entry for Benzydamine
insert:
Betaine
C4599
 
 
Homocystinuria
The treatment must be as adjunctive therapy to current standard care; AND
The condition must be treated by or in consultation with a metabolic physician
The name of the specialist must be included in the authority application
Compliance with Authority Required procedures

[63]         Schedule 4, Part 1, entry for Bevacizumab
substitute:

Bevacizumab
C4584
 
 
Where the patient is receiving treatment at/from a Public Hospital
Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with bevacizumab for this condition; AND
Patient must not have progressive disease; AND
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks; AND
The treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer
Compliance with Authority Required procedures - Streamlined Authority Code 4584


 
C4585
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with bevacizumab for this condition; AND
Patient must not have progressive disease; AND
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks; AND
The treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer
Compliance with Authority Required procedures


 
C4587
 
 
Where the patient is receiving treatment at/from a Public Hospital
Metastatic colorectal cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with bevacizumab for this condition; AND
Patient must not have progressive disease; AND
The treatment must be in combination with first-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
The patient's body weight must be documented in the patient's medical records at the time the treatment cycle is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4587


 
C4588
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Metastatic colorectal cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with bevacizumab for this condition; AND
Patient must not have progressive disease; AND
The treatment must be in combination with first-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


 
C4589
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Initial treatment
The condition must be suboptimally debulked (maximum diameter of any gross residual disease greater than 1 cm); AND
Patient must have a WHO performance status of 2 or less; AND
The condition must be previously untreated; AND
The treatment must be commenced in combination with platinum-based chemotherapy; AND
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks; AND
The treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer
The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated
Compliance with Authority Required procedures


 
C4594
 
 
Where the patient is receiving treatment at/from a Public Hospital
Metastatic colorectal cancer
Initial treatment
The condition must be previously untreated; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be in combination with first-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
The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4594


 
C4597
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Metastatic colorectal cancer
Initial treatment
The condition must be previously untreated; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be in combination with first-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


 
C4598
 
 
Where the patient is receiving treatment at/from a Public Hospital
Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Initial treatment
The condition must be suboptimally debulked (maximum diameter of any gross residual disease greater than 1 cm); AND
Patient must have a WHO performance status of 2 or less; AND
The condition must be previously untreated; AND
The treatment must be commenced in combination with platinum-based chemotherapy; AND
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks; AND
The treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer
The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4598


[64]         Schedule 4, Part 1, entry for Calcium
substitute:
Calcium
C4586
 
 
Hyperphosphataemia
The condition must be associated with chronic renal failure
Compliance with Authority Required procedures - Streamlined Authority Code 4586
[65]         Schedule 4, Part 1, entry for Erlotinib
(a)      omit:

 
C4481
 
 
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy; AND
Patient must not have received previous PBS-subsidised treatment with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI); OR
Patient must have developed intolerance to another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal; AND
Patient must have failed prior therapy which included a platinum compound; AND
Patient must have a WHO performance status of 3 or less; AND
The condition must have progressed following treatment with docetaxel or pemetrexed; OR
Patient must have a contraindication or intolerance to treatment with docetaxel and pemetrexed; AND
Patient must not be able to receive further chemotherapy subsidised by the PBS or from other sources following treatment with erlotinib
Patient must have a wild type epidermal growth factor receptor (EGFR) gene; OR
Patient must have an epidermal growth factor receptor (EGFR) gene of unknown type
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Non-Small Cell Lung Cancer Erlotinib Authority Application - Supporting Information Form, which includes:
(i) evidence that the patient has been treated with platinum-based chemotherapy; AND
(ii) evidence that disease progression has occurred following treatment with docetaxel or pemetrexed. In patients in whom docetaxel or pemetrexed is contraindicated or cannot be tolerated the prescriber must state the reasons for intolerance or the contraindication; AND
(iii) a declaration from the prescriber that the patient has exhausted all opportunities for treatment with chemotherapy either on the PBS, through special access schemes or in a clinical trial; and
(3) a signed patient acknowledgement
Compliance with Written Authority Required procedures


 
C4525
 
 
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be as monotherapy; AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not have progressive disease
Patient must have a wild type epidermal growth factor receptor (EGFR) gene; OR
Patient must have an epidermal growth factor receptor (EGFR) gene of unknown type
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Non-Small Cell Lung Cancer Erlotinib Authority Application - Supporting Information Form, which includes:
(i) evidence that the patient has been treated with platinum-based chemotherapy; AND
(ii) evidence that disease progression has occurred following treatment with docetaxel or pemetrexed. In patients in whom docetaxel or pemetrexed is contraindicated or cannot be tolerated the prescriber must state the reasons for intolerance or the contraindication; AND
(iii) a declaration from the prescriber that the patient has exhausted all opportunities for treatment with chemotherapy either on the PBS, through special access schemes or in a clinical trial; and
(3) a signed patient acknowledgement
Compliance with Written Authority Required procedures


 
C4536
 
 
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be as monotherapy; AND
Patient must have previously been issued with an authority prescription for this drug prior to 1 January 2014; AND
Patient must not have progressive disease
Patient must have a wild type epidermal growth factor receptor (EGFR) gene; OR
Patient must have an epidermal growth factor receptor (EGFR) gene of unknown type
Compliance with Authority Required procedures


(b)      insert in numerical order following existing text:
 
C4600
 
 
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be as monotherapy; AND
Patient must have previously been issued with an authority prescription for this drug prior to 1 August 2014; AND
Patient must not have progressive disease
Patient must have a wild type epidermal growth factor receptor (EGFR) gene; OR
Patient must have an epidermal growth factor receptor (EGFR) gene of unknown type
Compliance with Authority Required procedures

[66]         Schedule 4, Part 1, entry for Macrogol 3350
(a)      omit:

 
C1263
P1263
 
Patients receiving palliative care
 

 
C1613
P1613
 
Constipation in patients with malignant neoplasia
 

 
C2693
P2693
 
Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function not responding to other oral therapies
 

 
C2823
P2823
 
Chronic constipation or faecal impaction not adequately controlled with first line interventions such as bulk‑forming agents
 

 
C3642
P3642
 
Initial supply, for up to 4 months, for a palliative care patient where constipation is a problem
Compliance with Authority Required procedures – Streamlined Authority Code 3642

 
C3643
P3643
 
Continuing supply for a palliative care patient where constipation is a problem
Compliance with Authority Required procedures – Streamlined Authority Code 3643

(b)      insert in numerical order following existing text:

 
C4576
P4576
 
Constipation
Patient must have malignant neoplasia
 

 
C4577
P4577
 
Constipation
Patient must be receiving palliative care
 

 
C4580
P4580
 
Constipation
Patient must be paraplegic, quadriplegic or have severe neurogenic impairment of bowel function; AND
The condition must be unresponsive to other oral therapies
 

 
C4590
P4590
 
Constipation
Continuing treatment
Patient must be receiving palliative care
Compliance with Authority Required procedures - Streamlined Authority Code 4590

 
C4595
P4595
 
Constipation
Initial treatment
Patient must be receiving palliative care; AND
Patient must not receive more than 4 months treatment under this restriction
Compliance with Authority Required procedures - Streamlined Authority Code 4595

 
C4596
P4596
 
Chronic constipation
The condition must be inadequately controlled with first line interventions such as bulk-forming agents
 

 
C4601
P4601
 
Faecal impaction
The condition must be inadequately controlled with first line interventions such as bulk-forming agents
 

[67]         Schedule 4, Part 1, entry for Metronidazole
(a)      omit from the column headed “Circumstances Code”:     C4167   substitute:             C4581
(b)      omit from the column headed “Circumstances Code”:     C4168   substitute:             C4592
(c)      omit from the column headed “Circumstances Code”:     C4169   substitute:             C4593