National Health Act 1953 Amendment declaration under subsections 85(2) and 85(2AA) Amendment determination under subsection 85(2A) drugs and medicinal preparations (No. PB 75 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 75 of 2009

Amendment declaration under subsections 85(2) and 85(2AA) of the National Health Act 1953

Amendment determination under subsection 85(2A) of the National Health Act 1953

I, LINDA JACKSON, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsections 85(2), 85(2A) and 85(2AA) of the National Health Act 1953.

Dated 31 July 2009

LINDA JACKSON

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment declaration and determination — drugs and medicinal preparations

1              Commencement

This instrument commences on 1 September 2009.

2              Amendment of PB 113 of 2008

Schedule 1 amends PB 113 of 2008.

Schedule 1        Amendments

1. Schedule 1, item dealing with Cladribine

omit all text and substitute in the columns in the order indicated:

In compliance with authority procedures set out in subparagraph 14 (d):
3180	Hairy cell leukaemia

1. Schedule 1, item dealing with Fotemustine

omit all text and substitute in the columns in the order indicated:

In compliance with authority procedures set out in subparagraph 14 (d):
3181	Metastatic malignant melanoma

1. Schedule 1, item dealing with Irinotecan

omit all text and substitute in the columns in the order indicated:

In compliance with authority procedures set out in subparagraph 14 (d):
3184	Metastatic colorectal cancer in patients with a World Health Organisation performance status of 2 or less

1. Schedule 1, item dealing with Lansoprazole

omit from the column headed “Circumstances”:

In respect of the capsule 30 mg:

and substitute:

In respect of the tablet 30 mg (orally disintegrating) and capsule 30 mg:

1. Schedule 1, after item dealing with Polygeline

insert in the columns in the order indicated:

Poly-l-lactic acid

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Maintenance PBS-subsidised treatment, for facial administration only, of severe facial lipoatrophy caused by therapy for HIV infection;

 accreditation following completion of injection administration training with Sanofi-Aventis is required to prescribe poly-l-lactic acid under the PBS;

 patients must be referred from the HIV physician to the accredited injector

In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii):

Initial PBS-subsidised treatment, for facial administration only, of severe facial lipoatrophy caused by therapy for HIV infection;

 accreditation following completion of injection administration training with Sanofi-Aventis is required to prescribe poly-l-lactic acid under the PBS;

 patients must be referred from the HIV physician to the accredited injector

1. Schedule 1, item dealing with Raltitrexed

omit all text and substitute in the columns in the order indicated:

In compliance with authority procedures set out in subparagraph 14 (d):
3185	For use as a single agent in the treatment of advanced colorectal cancer

1. Schedule 1, after item dealing with Sevelamer

insert in the columns in the order indicated:

Silver sulfadiazine	Prevention and treatment of infection in partial or full skin thickness loss due to burns
Prevention and treatment of infection in partial or full skin thickness loss due to epidermolysis bullosa
Stasis ulcers

1. Schedule 1, after item dealing with Sodium Acid Phosphate

insert in the columns in the order indicated:

Sodium bicarbonate —

1. Schedule 1, item dealing with Topotecan

omit all text and substitute in the columns in the order indicated:

In compliance with authority procedures set out in subparagraph 14 (d):
3186	Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound