PB 67 of 2011
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011
(No.10)1
National Health Act 1953
I, KIM BESSELL, Acting First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this Instrument under sections 84AF, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 19 September 2011
KIM BESSELL
Acting First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing
1 Name of Instrument
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 10).
(2) This Instrument may also be cited as PB 67 of 2011.
2 Commencement
This Instrument commences on 1 October 2011.
3 Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010)
Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).
Schedule 1 Amendments
[1] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Max Quantity 2; Number of Repeats 5]
omit from the column headed “Circumstances”: C370 substitute: C3750
[2] Schedule 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 100 mg
omit:
Cardinorm
HX
MP NP
C1350
30
5
[3] Schedule 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 200 mg
omit:
Cardinorm
HX
MP NP
C1350
30
5
[4] Schedule 1, entry for Cimetidine
substitute:
Cimetidine
Tablet 400 mg
Oral
Magicul 400
AF
MP NP
60
5
Tablet 800 mg
Oral
Magicul 800
AF
MP NP
30
5
[5] Schedule 1, entry for Clodronic Acid in the form Capsule containing 400 mg sodium clodronate (as tetrahydrate)
omit from the column headed “Responsible Person”: SC substitute: BN
[6] Schedule 1, entry for Clodronic Acid in the form Capsule containing 800 mg sodium clodronate (as tetrahydrate)
(a) omit from the column headed “Form”: Capsule substitute: Tablet
(b) omit from the column headed “Responsible Person”: SC substitute: BN
[7] Schedule 1, entry for Clopidogrel with aspirin
substitute:
Clopidogrel with aspirin
Tablet 75 mg (as hydrogen sulfate)-100 mg
Oral
Clopidogrel Winthrop plus aspirin
WA
MP NP
C1722 C3219 C3246
30
5
CoPlavix
SW
MP NP
C1722 C3219 C3246
30
5
DuoCover
BQ
MP NP
C1722 C3219 C3246
30
5
[8] Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg
omit from the column headed “Responsible Person” (twice occurring): SC substitute: BN
[9] Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg
omit from the column headed “Responsible Person”: SC substitute: BN
[10] Schedule 1, entry for Degarelix
(a) omit from the column headed “Form”: Powder for injection 80 mg (as acetate) with solvent, syringe and needles
substitute: Powder for injection 80 mg (as acetate), injection set
(b) omit from the column headed “Form”: Powder for injection 120 mg (as acetate) with solvent, syringe and needles, 2
substitute: Powder for injection 120 mg (as acetate), 2, injection set
[11] Schedule 1, after entry for Docetaxel in the form Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent
insert in the columns in the order indicated:
Powder for I.V. infusion 20 mg with solvent
Injection
Docetaxel SUN
ZF
MP
C1194 C1742 C2732 C3428
2
0
Powder for I.V. infusion 80 mg with solvent
Injection
Docetaxel SUN
ZF
MP
C1194 C1742 C2732 C3428
1
0
[12] Schedule 1 entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL [Max Quantity 1; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Docetaxel Sandoz
SZ
MP
C1194 C1742 C2416 C2439 C2732 C3051 C3428
P3051
1
0
[13] Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL [Max Quantity 2; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Docetaxel Sandoz
SZ
MP
C1194 C1742 C2416 C2439 C2732 C3051 C3428
P1194 P1742 P2416 P2439 P2732 P3428
2
0
[14] Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Docetaxel Sandoz
SZ
MP
C1194 C1742 C2416 C2439 C2732 C3051 C3428
1
0
[15] Schedule 1, entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg
omit from the column headed “Responsible Person”: GQ substitute: TA
[16] Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride)
omit from the column headed “Responsible Person”: GQ substitute: TA
[17] Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride)
omit from the column headed “Responsible Person”: GQ substitute: TA
[18] Schedule 1, entry for Glimepiride in the form Tablet 1 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Glimepiride GA 1
GM
MP NP
30
5
[19] Schedule 1, entry for Glimepiride in the form Tablet 2 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Glimepiride GA 2
GM
MP NP
30
5
[20] Schedule 1, entry for Glimepiride in the form Tablet 3 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Glimepiride GA 3
GM
MP NP
30
5
[21] Schedule 1, entry for Glimepiride in the form Tablet 4 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Glimepiride GA 4
GM
MP NP
30
5
[22] Schedule 1, entry for Iloprost
omit from the column headed “Responsible Person”: SC substitute: BN
[23] Schedule 1, entry for Interferon Beta-1b
omit from the column headed “Responsible Person”: SC substitute: BN
[24] Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL
(a) omit from the column headed “Responsible Person”: GQ substitute: TA
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Irinotecan Kabi
PK
MP
See Note 1
C3184
1
3
[25] Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL
(a) omit from the column headed “Responsible Person”: GQ substitute: TA
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Irinotecan Kabi
PK
MP
See Note 1
C3184
2
3
[26] Schedule 1, entry for Levonorgestrel
omit from the column headed “Responsible Person” (twice occurring): SC substitute: BN
[27] Schedule 1, entry for Levonorgestrel with Ethinyloestradiol in the form Pack containing 21 tablets 125 micrograms-50 micrograms and 7 inert tablets
omit from the column headed “Responsible Person”: SC substitute: BN
[28] Schedule 1, entry for Levonorgestrel with Ethinyloestradiol in the form Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets
omit from the column headed “Responsible Person”: SC substitute: BN
[29] Schedule 1, entry for Levonorgestrel with Ethinyloestradiol in the form Pack containing 6 tablets 50 micrograms-30 micrograms, 5 tablets 75 micrograms-40 micrograms, 10 tablets 125 micrograms-30 micrograms and 7 inert tablets
omit from the column headed “Responsible Person”: SC substitute: BN
[30] Schedule 1, entry for Macrogol 3350 in the form Powder for oral solution 510 g [Max Quantity 2; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
your pharmacy Clear Laxative
TW
MP NP
C1263 C1613 C2693 C2823 C3642 C3643
P3643
2
0
[31] Schedule 1, entry for Macrogol 3350 in the form Powder for oral solution 510 g [Max Quantity 2; Number of Repeats 3]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
your pharmacy Clear Laxative
TW
MP NP
C1263 C1613 C2693 C2823 C3642 C3643
P3642
2
3
[32] Schedule 1, entry for Macrogol 3350 in the form Powder for oral solution 510 g [Max Quantity 1; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
your pharmacy Clear Laxative
TW
MP NP
C1263 C1613 C2693 C2823 C3642 C3643
P1263 P1613 P2693 P2823
1
5
[33] Schedule 1, entry for Metronidazole in the form I.V. infusion 500 mg in 100 mL
(a) omit:
Metronidazole Sandoz
SZ
PDP
C1448
5
0
(b) omit:
Metronidazole Sandoz
SZ
MP NP
C1300 C1448
5
1
[34] Schedule 1, entry for Norethisterone in the form Tablet 5 mg
omit from the column headed “Responsible Person”: SC substitute: BN
[35] Schedule 1, entry for Oestradiol
omit from the column headed “Responsible Person” (all instances): SC substitute: BN
[36] Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 50 mg in 10 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Oxaliplatin SUN
ZF
MP
See Note 1
C2717 C3449 C3450
1
2
[37] Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 50 mg
omit from the column headed “Responsible Person”: GQ substitute: TA
[38] Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Oxaliplatin SUN
ZF
MP
See Note 1
C2717 C3449 C3450
1
2
[39] Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 100 mg
omit from the column headed “Responsible Person”: GQ substitute: TA
[40] Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 200 mg in 40 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Oxaliplatin SUN
ZF
MP
See Note 1
C2717 C3449 C3450
1
2
[41] Schedule 1, entry for Paclitaxel in each of the forms: Solution concentrate for I.V. infusion 30 mg in 5 mL; Solution concentrate for I.V. infusion 100 mg in 16.7 mL; Solution concentrate for I.V. infusion 150 mg in 25 mL; and Solution concentrate for I.V. infusion 300 mg in 50 mL
omit from the column headed “Responsible Person”: GQ substitute: TA
[42] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 5]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Cholvastin
RA
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
(b) omit:
Vastoran
RA
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[43] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 11]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Cholvastin
RA
MP
C1540 C3047
P3047
30
11
(b) omit:
Vastoran
RA
MP
C1540 C3047
P3047
30
11
[44] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 5]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Cholvastin
RA
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
(b) omit:
Vastoran
RA
MP
C1540 C3047
P1540
30
5
NP
C1540
30
5
[45] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 11]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Cholvastin
RA
MP
C1540 C3047
P3047
30
11
(b) omit:
Vastoran
RA
MP
C1540 C3047
P3047
30
11
[46] Schedule 1, entry for Ranibizumab
omit from the column headed “Circumstances”:
C3788
insert in numerical order:
C3859
[47] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b
(a) omit:
Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 50 micrograms with diluent
Injection/oral
Pegatron
MK
MP
See Note 1
C3053 C3055 C3413 C3414
2
5
D
(b) omit:
Pack containing 168 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent
Injection/oral
Pegatron
MK
MP
See Note 1
C3053 C3055 C3413 C3414
2
5
D
(c) omit:
Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 100 micrograms with diluent
Injection/oral
Pegatron
MK
MP
See Note 1
C3053 C3055 C3413 C3414
2
5
D
(d) omit:
Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 120 micrograms with diluent
Injection/oral
Pegatron
MK
MP
See Note 1
C3053 C3055 C3413 C3414
2
5
D
(e) omit:
Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent
Injection/oral
Pegatron
MK
MP
See Note 1
C3053 C3055 C3413 C3414
2
5
D
[48] Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 35 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Risedronate-GA
GM
MP NP
C2645 C2646 C3070
4
5
[49] Schedule 1, entry for Testosterone
omit from the column headed “Responsible Person”(all instances): SC substitute: BN
[50] Schedule 1, after entry for Tobramycin in the form Injection 500 mg (as sulfate) in 5 mL (without preservative)
insert in the columns in the order indicated:
Solution for inhalation 300 mg in 5 mL
Inhalation
Tobi
NV
MP
C3842
56
2
[51] Schedule 1, entry for Verteporfin
omit from the column headed “Circumstances”:
C3793 C3794
insert in numerical order:
C3860 C3861
[52] Schedule 1, entry for Vinorelbine in the form Solution for I.V. infusion 10 mg (as tartrate) in 1 mL
omit:
Vinorelbine Kabi
PK
MP
See Note 1
C1194 C1741
16
2
Vinorelbine Link
FU
MP
See Note 1
C1194 C1741
16
2
[53] Schedule 1, entry for Vinorelbine in the form Solution for I.V. infusion 50 mg (as tartrate) in 5 mL
(a) omit:
Vinorelbine Link
FU
MP
See Note 1
C1194 C1741
4
2
[54] Schedule 3
omit:
FU
Fresenius Kabi Australia Pty Limited
39 109 383 593
[55] Schedule 3
omit:
SC
Bayer Australia Ltd
22 000 138 714
[56] Schedule 3, details relevant to code ZF
omit: Sun Pharmaceutical Industries Pty Ltd substitute: Sun Pharmaceutical Industries (Australia) Pty Ltd
[57] Schedule 4, Part 1, entry for Ranibizumab [Circumstances Code C3788]
omit from the column headed “Circumstances”: C3788 substitute: C3859
[58] Schedule 4, Part 1, entry for Tobramycin
insert after existing text in the columns in the order indicated:
C3842
Management of a proven Pseudomonas aeruginosa infection in a patient with cystic fibrosis
Compliance with Authority Required procedures - Streamlined Authority Code 3842
[59] Schedule 4, Part 1, entry for Verteporfin [Circumstances Code C3793]
omit from the column headed “Circumstances”: C3793 substitute: C3860
[60] Schedule 4, Part 1, entry for Verteporfin [Circumstances Code C3794]
omit from the column headed “Circumstances”: C3794 substitute: C3861
1Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.
See http://www.frli.gov.au.
