Instrument number PB 36 of 2009
Amendment special arrangements under subsection 100(1) of the National Health Act 1953
I, DIANA MACDONELL, Acting Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsection 100(1) of the National Health Act 1953.
Dated 2nd April 2009
DIANA MACDONELL
Acting Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
Amendment Special Arrangements — Chemotherapy Pharmaceuticals Access Program
1 Commencement
This instrument commences on 1 May 2009.
2 Amendment of PB 121 of 2008
Schedule 1 amends PB 121 of 2008.
Schedule 1 Amendments
[1] Schedule 1, after item dealing with Paclitaxel
insert in the columns in the order indicated:
Paclitaxel, nanoparticle albumin-bound | In compliance with authority procedures set out in paragraph 14:
Metastatic breast cancer after failure of prior therapy which includes an anthracycline |
[2] Schedule 2, item dealing with Etoposide
(a) omit from the column headed “Form”:
Powder for I.V. infusion containing etoposide phosphate 113.6 mg
and substitute:
Powder for I.V. infusion 100 mg (as phosphate)
(b) omit from the column headed “Form”:
Powder for I.V. infusion containing etoposide phosphate 1.136 g
and substitute:
Powder for I.V. infusion 1 g (as phosphate)
[3] Schedule 2, item dealing with Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride)
in the column headed “Brand” insert in alphabetical order:
DBL Gemcitabine for Injection
[4] Schedule 2, item dealing with Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride)
in the column headed “Brand” insert in alphabetical order:
DBL Gemcitabine for Injection
[5] Schedule 2, after item dealing with Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride)
insert in the columns in the order indicated:
| Powder for I.V. infusion 2 g (as hydrochloride) | Injection | 1 | 2 | DBL Gemcitabine for Injection |
[6] Schedule 2, after item dealing with Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in
5 mL
insert in the columns in the order indicated:
| I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in | Injection | 1 | 3 | Camptosar |
[7] Schedule 2, item dealing with Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)
in the column headed “Brand” insert in alphabetical order:
APO-Ondansetron
[8] Schedule 2, item dealing with Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate)
in the column headed “Brand” insert in alphabetical order:
APO-Ondansetron
[9] Schedule 2, after item dealing with Paclitaxel
insert in the columns in the order indicated:
Paclitaxel, nanoparticle albumin-bound | Powder for I.V. injection containing | Injection | 1 | .. | Abraxane |