National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 9) (No. PB 70 of 2011) (Cth)
PB 70 of 2011
National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No. 9)
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 subsections 100(1) and (2) of the National Health Act 1953.
Dated 22 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 (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011 (No.9).
(2)This Instrument may also be cited as PB 70 of 2011.
2 Commencement
This Instrument commences on 1 October 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
Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL
substitute:
| Solution concentrate for I.V. infusion 20 mg in 2 mL | Injection | DBL Docetaxel Concentrated Injection | HH | EMP | C1194 C1742 C2416 C2439 C2732 C3051 C3428 | P3051 | 1 | 0 |
| Docetaxel Ebewe | HX | EMP | C1194 C1742 C2416 C2732 C3051 C3428 | P3051 | 1 | 0 | ||
| Docetaxel Sandoz | SZ | EMP | C1194 C1742 C2416 C2439 C2732 C3051 C3428 | P3051 | 1 | 0 | ||
| DBL Docetaxel Concentrated Injection | HH | EMP | C1194 C1742 C2416 C2439 C2732 C3051 C3428 | P1194 P1742 P2416 P2439 P2732 P3428 | 2 | 0 | ||
| Docetaxel Ebewe | HX | EMP | C1194 C1742 C2416 C2732 C3051 C3428 | P1194 P1742 P2416 P2732 P3428 | 2 | 0 | ||
| Docetaxel Sandoz | SZ | EMP | C1194 C1742 C2416 C2439 C2732 C3051 C3428 | P1194 P1742 P2416 P2439 P2732 P3428 | 2 | 0 |
Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL
substitute:
| Solution concentrate for I.V. infusion 80 mg in 8 mL | Injection | DBL Docetaxel Concentrated Injection | HH | EMP | C1194 C1742 C2416 C2439 C2732 C3051 C3428 | 1 | 0 |
| Docetaxel Ebewe | HX | EMP | C1194 C1742 C2416 C2732 C3051 C3428 | 1 | 0 | ||
| Docetaxel Sandoz | SZ | EMP | C1194 C1742 C2416 C2439 C2732 C3051 C3428 | 1 | 0 |
Schedule 1, entry for Docetaxel, after Solution concentrate for I.V. infusion 160 mg in 16 mL
insert:
| Powder for I.V. infusion 20 mg with solvent | Injection | Docetaxel SUN | ZF | EMP | C1194 C1742 C2732 C3428 | 2 | 0 |
| Powder for I.V. infusion 80 mg with solvent | Injection | Docetaxel SUN | ZF | EMP | C1194 C1742 C2732 C3428 | 1 | 0 |
Schedule 1, entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg, in the column headed ‘Responsible Person’
omit:
GQ
substitute:
TA
Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride), in the column headed ‘Responsible Person’
omit:
GQ
substitute:
TA
Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride), in the column headed ‘Responsible Person’
omit:
GQ
substitute:
TA
Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL
substitute:
| Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL | Injection | Camptosar | PF | EMP | C3184 | 1 | 3 |
| Hospira Pty Limited | HH | EMP | C3184 | 1 | 3 | |||
| Irinotecan Actavis | TA | EMP | C3184 | 1 | 3 | |||
| Irinotecan Alphapharm | AF | EMP | C3184 | 1 | 3 | |||
| Irinotecan Ebewe | SZ | EMP | C3184 | 1 | 3 | |||
| Irinotecan Kabi | PK | EMP | C3184 | 1 | 3 | |||
| Omegapharm Irinotecan | OE | EMP | C3184 | 1 | 3 | |||
| Tecan | WQ | EMP | C3184 | 1 | 3 |
Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL
substitute:
| I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL | Injection | Camptosar | PF | EMP | C3184 | 2 | 3 |
| Hospira Pty Limited | HH | EMP | C3184 | 2 | 3 | ||
| Irinotecan Actavis | TA | EMP | C3184 | 2 | 3 | ||
| Irinotecan Alphapharm | AF | EMP | C3184 | 2 | 3 | ||
| Irinotecan Ebewe | SZ | EMP | C3184 | 2 | 3 | ||
| Irinotecan Kabi | PK | EMP | C3184 | 2 | 3 | ||
| Omegapharm Irinotecan | OE | EMP | C3184 | 2 | 3 | ||
| Tecan | WQ | EMP | C3184 | 2 | 3 |
Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 50 mg in 10 mL
insert in alphabetical order by brand name:
| Oxaliplatin SUN | ZF | EMP | C2717 C3449 C3450 | 1 | 2 |
[10] Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 50 mg, in the column headed ‘Responsible Person’
omit:
GQ
substitute:
TA
[11] Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL
insert in alphabetical order by brand name:
| Oxaliplatin SUN | ZF | EMP | C2717 C3449 C3450 | 1 | 2 |
[12] Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 100 mg, in the column headed ‘Responsible Person’
omit:
GQ
substitute:
TA
[13] Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 200 mg in 40 mL
insert in alphabetical order by brand name:
| Oxaliplatin SUN | ZF | EMP | C2717 C3449 C3450 | 1 | 2 |
[14] Schedule 1, entry for Paclitaxel in the form Solution Concentrate for I.V. infusion 30 mg in 5 mL, in the column headed ‘Responsible Person’
omit:
GQ
substitute:
TA
[15] Schedule 1, entry for Paclitaxel in the form Solution Concentrate for I.V. infusion 100 mg in 16.7 mL, in the column headed ‘Responsible Person’
omit:
GQ
substitute:
TA
[16] Schedule 1, entry for Paclitaxel in the form Solution Concentrate for I.V. infusion 150 mg in 25 mL, in the column headed ‘Responsible Person’
omit:
GQ
substitute:
TA
[17] Schedule 1, entry for Paclitaxel in the form Solution Concentrate for I.V. infusion 300 mg in 50 mL, in the column headed ‘Responsible Person’
omit:
GQ
substitute:
TA
[18] 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 | |||
| 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 |
[19] Schedule 2, Responsible Person Codes
omit:
| FU | Fresenius Kabi Australia Pty Limited | 39 109 383 593 |
[20] Schedule 2, Responsible Person Codes
omit:
| GQ | Generic Health Pty Ltd | 93 110 617 859 |
Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.
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