PB 47 of 2011
National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 6)
National Health Act 1953
___________________________________________________________________________
I, FELICITY MCNEILL, Acting First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.
Dated 16 June 2011
FELICITY MCNEILL
Acting First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing
___________________________________________________________________
1 Name of Instrument
(1) This Instrument is the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No.6).
(2) This Instrument may also be cited as PB 47 of 2011.
2 Commencement
This Instrument commences on 1 July 2011.
3 Amendments to PB 117 of 2010
Schedule 1 amends the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010 (PB 117 of 2010).
.
Schedule 1 Amendments
[1] Schedule 1, entry for Aprepitant
omit from the column headed Number of Repeats:
0
and substitute:
5
[2] Schedule 1, entry for “BCG-Tice” (Bacillus Calmette-Guerin/ Tice strain)
omit from the column headed Responsible Person:
SH
and substitute:
MK
[3] Schedule 1, entry for Bleomycin
substitute:
Bleomycin
Powder for injection containing bleomycin sulfate 15,000 I.U. (with any determined brand of sodium chloride injection as the required solvent)
Injection
Hospira Pty Limited
HH
EMP
C1139 C1198
10
0
[4] Schedule 1, entry for Carboplatin in the form Solution for I.V. injection 50 mg in 5 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[5] Schedule 1, entry for Carboplatin in the form Solution for I.V. injection 150 mg in 15 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[6] Schedule 1, entry for Carboplatin in the form Solution for I.V. injection 450 mg in 45 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[7] Schedule 1, entry for Cisplatin in the form I.V. injection 100 mg in 100 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[8] Schedule 1, entry for Docetaxel
substitute:
Docetaxel
Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL with solvent
Injection
Taxotere
SW
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
P3051
1
0
Taxotere
SW
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
P1194 P1742 P2416 P2439 P2732 P3292 P3428
2
0
Solution concentrate for I.V. infusion 20 mg in 1 mL
Injection
Oncotaxel 20
TA
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
P3051
1
0
Taxotere
SW
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
P3051
1
0
Oncotaxel 20
TA
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
P1194 P1742 P2416 P2439 P2732 P3292 P3428
2
0
Taxotere
SW
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
P1194 P1742 P2416 P2439 P2732 P3292 P3428
2
0
Solution concentrate for I.V. infusion 20 mg in 2 mL
Injection
DBL Docetaxel Concentrated Injection
HH
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
P3051
1
0
Docetaxel Ebewe
HX
EMP
C1194 C1742 C2416 C2732 C3051 C3428
P3051
1
0
DBL Docetaxel Concentrated Injection
HH
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
P1194 P1742 P2416 P2439 P2732 P3292 P3428
2
0
Docetaxel Ebewe
HX
EMP
C1194 C1742 C2416 C2732 C3051 C3428
P1194 P1742 P2416 P2732 P3428
2
0
Solution concentrate for I.V. infusion 80 mg in 4 mL
Injection
Oncotaxel 80
TA
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
1
0
Taxotere
SW
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
1
0
Solution concentrate for I.V. infusion 80 mg in 8 mL
Injection
DBL Docetaxel Concentrated Injection
HH
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
1
0
Docetaxel Ebewe
HX
EMP
C1194 C1742 C2416 C2732 C3051 C3428
1
0
Solution concentrate for I.V. infusion 140 mg in 7 mL
Injection
Oncotaxel 140
TA
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
1
0
Solution concentrate for I.V. infusion 160 mg in 16 mL
Injection
DBL Docetaxel Concentrated Injection
HH
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
1
0
Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent
Injection
Taxotere
SW
EMP
C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428
1
0
[9] Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[10] Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[11] Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 100 mg in 50 mL single dose vial
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[12] Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[13] Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[14] Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[15] Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[16] Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[17] Schedule 1, entry for Etoposide in the form Solution for I.V. infusion 100 mg in 5 mL vial
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[18] Schedule 1, entry for Fludarabine in the form Solution for I.V. injection 50 mg fludrabine phosphate in 2 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[19] Schedule 1, entry for Fluorouracil in the form Injection 500 mg in 10 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[20] Schedule 1, entry for Fluorouracil in the form Injection 1000 mg in 20 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[21] Schedule 1, entry for Fluorouracil, after the form Injection 1000 mg in 20 mL
insert:
Injection 2500 mg in 50 mL
Injection
Fluorouracil Ebewe
SZ
EMP
2
0
Injection 5000 mg in 100 mL
Injection
Fluorouracil Ebewe
SZ
EMP
1
0
[22] Schedule 1, entry for Folinic acid in the form Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[23] Schedule 1, entry for Folinic acid in the form Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[24] Schedule 1, entry for Folinic acid in the form Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[25] Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride)
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[26] Schedule 1, entry for Gemcitabine in the form Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[27] Schedule 1, entry for Gemcitabine in the form Solution concentrate for I.V. infusion 500 mg (as hydrochloride) in 50 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[28] Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride)
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[29] Schedule 1, entry for Gemcitabine in the form Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[30] Schedule 1, entry for Idarubicin in the form Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[31] Schedule 1, entry for Idarubicin in the form Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[32] Schedule 1, entry for Interferon Alfa-2b
omit from the column headed Responsible Person (all instances):
SH
and substitute:
MK
[33] Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[34] Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL
omit:
Irinotecan Sandoz
SZ
EMP
C3184
1
3
[35] Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[36] Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL
omit:
Irinotecan Sandoz
SZ
EMP
C3184
1
3
D
[37] Schedule 1, entry for Methotrexate in the form Solution concentrate for I.V. infusion 1000 mg in 10 mL vial
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[38] Schedule 1, entry for Methotrexate in the form Solution concentrate for I.V. infusion 5000 mg in 50 mL vial
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[39] Schedule 1, entry for Mitozantrone in the form Injection 20 mg (as hydrochloride) in 10 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[40] Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 50 mg
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[41] Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 100 mg
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[42] Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 30 mg in 5 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[43] Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 100 mg in 16.7 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[44] Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 150 mg in 25 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[45] Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL
omit from the column headed Responsible Person:
IT
and substitute:
SZ
[46] Schedule 1, entry for Vinorelbine
substitute:
Vinorelbine
Solution for I.V. infusion 10 mg (as tartrate) in 1 mL
Injection
Hospira Pty Limited
HH
EMP
C1194 C1741
16
2
Navelbine
FB
EMP
C1194 C1741
16
2
Vinorelbine Ebewe
SZ
EMP
C1194 C1741
16
2
Vinorelbine Kabi
PK
EMP
C1194 C1741
16
2
Vinorelbine Link
FU
EMP
C1194 C1741
16
2
Solution for I.V. infusion 50 mg (as tartrate) in 5 mL
Injection
Hospira Pty Limited
HH
EMP
C1194 C1741
4
2
Navelbine
FB
EMP
C1194 C1741
4
2
Vinorelbine Ebewe
SZ
EMP
C1194 C1741
4
2
Vinorelbine Kabi
PK
EMP
C1194 C1741
4
2
Vinorelbine Link
FU
EMP
C1194 C1741
4
2
[47] Schedule 2, after:
FB
Pierre Fabre Medicament Australia Pty Ltd
30 098 999 850
insert:
FU
Fresenius Kabi Australia Pty Limited
39 109 383 593
[48] Schedule 2, after:
HH
Hospira Pty Limited
13 107 058 328
omit:
IT
InterPharma Pty Ltd
19 099 877 899
and substitute:
HW
Sandoz Pty Ltd
60 075 449 553
[49] Schedule 2, after:
SG
Merck Serono Australia Pty Ltd
72 006 900 830
omit:
SH
Schering-Plough Pty Limited
57 000 235 245
[50] Schedule 2, after:
SZ
Sandoz Pty Ltd
60 075 449 553
insert:
TA
Actavis Australia Pty Ltd
43 122 896 468
Note
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.
