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 1 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 1 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, 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 subsections 85(2), 85(2A) and 85(2AA) of the National Health Act 1953.

Dated 2nd JANUARY 2009

DIANA MACDONELL

Acting 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 February 2009.

2              Amendment of PB 113 of 2008

Schedule 1 amends PB 113 of 2008.

Schedule 1        Amendments

1. Schedule 1, item dealing with Clopidogrel

following the existing text, insert in the columns in the order indicated:

3069 Treatment of acute coronary syndromes (myocardial infarction or unstable angina) in combination with aspirin to prevent early and long-term atherothrombotic events

1. Schedule 1, after item dealing with Desmopressin

insert in the columns in the order indicated:

Desvenlafaxine Major depressive disorders

1. Schedule 1, item dealing with Influenza Vaccine

omit from “Column 3” (twice occurring):

A/Solomon Islands/3/2006

and substitute:

A/Brisbane/59/2007

1. Schedule 1, item dealing with Protein hydrolysate formula with medium chain triglycerides

omit from “Column 3”:

In respect of the oral powder 450 g (Pepti-Junior):

and substitute:

In respect of the oral powder 450 g (Pepti-Junior Gold):

1. Schedule 1, item dealing with Risedronic Acid

following “In compliance with authority procedures set out in subparagraph 14 (d):” (first occurring), insert in the columns in the order indicated:

3070  Treatment as the sole PBS-subsidised anti-resorptive agent for corticosteroid-induced osteoporosis in a patient currently on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy with a bone mineral density T-score of -1.5 or less, and where the duration and dose of corticosteroid therapy, and the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement, are documented in the patient's medical records when treatment is initiated

1. Schedule 1, item dealing with Risedronic Acid and Calcium

following “In compliance with authority procedures set out in subparagraph 14 (d):”, insert in the columns in the order indicated:

3070  Treatment as the sole PBS-subsidised anti-resorptive agent for corticosteroid-induced osteoporosis in a patient currently on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy with a bone mineral density T-score of -1.5 or less, and where the duration and dose of corticosteroid therapy, and the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement, are documented in the patient's medical records when treatment is initiated

1. Schedule 1, item dealing with Rosiglitazone

omit from the columns in the order indicated:

3037 Continuation of therapy in type 2 diabetes mellitus in a patient who has previously received and been stabilised on a PBS-subsidised regimen of oral anti-diabetic medicines which includes rosiglitazone maleate

1. Schedule 1, item dealing with Rosiglitazone with Metformin

omit from the columns in the order indicated:

3037 Continuation of therapy in type 2 diabetes mellitus in a patient who has previously received and been stabilised on a PBS-subsidised regimen of oral anti-diabetic medicines which includes rosiglitazone maleate

1. Schedule 1, after item dealing with Sodium Lactate Compound

insert in the columns in the order indicated:

Sorafenib	In compliance with authority procedures set out in subparagraph 14 (d):
Initial treatment, as the sole PBS-subsidised agent, of advanced (Barcelona Clinic Liver Cancer Stage C) hepatocellular carcinoma in a patient with a World Health Organisation performance status of 2 or less and Child Pugh class A
Continuing treatment, as the sole PBS-subsidised agent, of advanced hepatocellular carcinoma in a patient who has previously been treated with PBS-subsidised sorafenib and who does not have progressive disease

1. Schedule 1, after item dealing with Trimethoprim with Sulfamethoxazole

insert in the columns in the order indicated:

Triptorelin	In compliance with authority procedures set out in subparagraph 14 (d):
Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate

1. Schedule 1, after item dealing with Vinorelbine

insert in the columns in the order indicated:

Voriconazole	In compliance with authority procedures set out in subparagraph 14 (d):
For the treatment and maintenance therapy of definite or probable invasive aspergillosis in immunocompromised patients
For the treatment and maintenance therapy of serious fungal infections caused by Scedosporium species or Fusarium species
For the treatment and maintenance therapy of serious Candida infections where treatment with amphotericin has failed
For the treatment and maintenance therapy of serious Candida infections where treatment with amphotericin is not tolerated and the causative species is not susceptible to fluconazole
For the treatment and maintenance therapy of serious Candida infections where treatment with fluconazole has failed
For the treatment and maintenance therapy of serious Candida infections where treatment with fluconazole is not tolerated
For the treatment and maintenance therapy of other serious invasive mycosis where treatment with amphotericin has failed
For the treatment and maintenance therapy of other serious invasive mycosis where treatment with amphotericin is not tolerated