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 106 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 106 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 12 November 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 December 2009.

2              Amendment of PB 113 of 2008

Schedule 1 amends PB 113 of 2008.

Schedule 1        Amendments

1. Schedule 1, after item dealing with Amino acid formula with vitamins and minerals without valine, leucine and isoleucine

insert in the columns in the order indicated:

Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexanoic acid Maple syrup urine disease

1. Schedule 1, after item dealing with Arsenic

insert in the columns in the order indicated:

Artemether with lumefantrine	In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of suspected or confirmed malaria due to Plasmodium falciparum

1. Schedule 1, item dealing with Calcipotriol

omit all text in the column headed “Circumstances” and substitute:

In respect of the cream 50 micrograms (as monohydrate) per g, 30 g:

Chronic stable plaque type psoriasis vulgaris

In respect of the scalp solution 50 micrograms (as monohydrate) per mL, 30 mL:

Chronic stable plaque type psoriasis vulgaris of the scalp

1. Schedule 1, after item dealing with Calcipotriol

insert in the columns in the order indicated:

Calcipotriol with betamethasone Chronic stable plaque type psoriasis vulgaris in a patient who is not adequately controlled with either calcipotriol or potent topical corticosteroid monotherapy

1. Schedule 1, after item dealing with Clopidogrel

insert in the columns in the order indicated:

Clopidogrel with aspirin	In compliance with authority procedures set out in subparagraph 14 (d):
3218	Treatment of acute coronary syndromes (myocardial infarction or unstable angina) to prevent early and long-term atherothrombotic events
3219	Treatment following cardiac stent insertion
1722	Prevention of recurrence of myocardial infarction or unstable angina in patients with a history of symptomatic cardiac ischaemic events while on therapy with low-dose aspirin

1. Schedule 1, item dealing with Glucose Indicator—Blood

insert after ‘reagent strips, 50 (Glucostix)’ in the column headed “Circumstances”:

, reagent strips, 50 (Lifeline Attest)

1. Schedule 1, after item dealing with Hydroxychloroquine

insert in the columns in the order indicated:

Hydroxyethyl starch 130/0.4 —

1. Schedule 1, item dealing with Montelukast

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

Montelukast

In respect of the tablet, chewable, 4 mg (as sodium):

In compliance with authority procedures set out in subparagraph 14 (d):

2617

 First-line preventer medication, as the single preventer agent for children aged from 2 to less than 6 years with frequent intermittent or mild persistent asthma, as an alternative to sodium cromoglycate or nedocromil sodium

In respect of the tablet, chewable, 5 mg (as sodium):

In compliance with authority procedures set out in subparagraph 14 (d):

2618

 First-line preventer medication, as the single preventer agent for children aged from 6 to less than 15 years with frequent intermittent or mild persistent asthma, as an alternative to sodium cromoglycate or nedocromil sodium

3217

 Prevention of exercise-induced asthma, as an alternative to adding salmeterol xinafoate or eformoterol fumarate, in a child aged from 6 to less than 15 years whose asthma is otherwise well controlled while receiving optimal dose inhaled corticosteroid, but who requires short-acting beta-2 agonist 3 or more times per week for prevention or relief of residual exercise-related symptoms

1. Schedule 1, item dealing with Olanzapine

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

Olanzapine

In respect of the tablet 2.5 mg, tablet 5 mg, tablet 7.5 mg, tablet 10 mg, wafer 5 mg and wafer 10 mg:

In compliance with authority procedures set out in subparagraph 14 (d):

1589

 Schizophrenia

2044

 Maintenance treatment of bipolar I disorder

In respect of the powder for injection 210 mg (as pamoate monohydrate) with diluent and powder for injection 300 mg (as pamoate monohydrate) with diluent:

In compliance with authority procedures set out in subparagraph 14 (d):

1589

 Schizophrenia

1. Schedule 1, after item dealing with Pneumococcal Vaccine – Polyvalent

insert in the columns in the order indicated:

Polyethylene glycol 400

In respect of the eye drops 2.5 mg per mL, 15 mL:

Severe dry eye syndrome, including Sjogren's syndrome

For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

In respect of the eye drops 2.5 mg per mL, single dose units 0.4 mL, 20:

In compliance with authority procedures set out in subparagraph 14 (d):

1359

 Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops

1. Schedule 1, item dealing with Pramipexole

omit from the column headed “Circumstances” (three instances):

Parkinson's disease as adjunctive therapy in patients being treated with levodopa—decarboxylase inhibitor combinations

and substitute:

Parkinson disease

1. Schedule 1, after item dealing with Pramipexole

insert in the columns in the order indicated:

Prasugrel	In compliance with authority procedures set out in subparagraph 14 (d):
3208	Treatment of acute coronary syndrome (myocardial infarction or unstable angina) managed by percutaneous coronary intervention in combination with aspirin

1. Schedule 1, item dealing with Sunitinib

insert after existing text in the column headed “Circumstances”:

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

Initial PBS-subsidised treatment as monotherapy of a patient with World Health Organisation performance status of 2 or less with a metastatic or unresectable malignant gastrointestinal stromal tumour after failure of imatinib mesylate treatment due to resistance or intolerance, and where the application for authorisation includes:

 (1)  a completed copy of the appropriate Sunitinib Malate (Sutent) PBS Authority Application for Use in the Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form; and

 (2)  a signed patient acknowledgement

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

 Continuing PBS-subsidised treatment as monotherapy of a patient with World Health Organisation performance status of 2 or less with a metastatic or unresectable malignant gastrointestinal stromal tumour who has previously been issued with an authority prescription for sunitinib and who does not have progressive disease on sunitinib

1. Schedule 1, omit item dealing with Tamarindus indica seed polysaccharide

1. Schedule 2A, after item dealing with Pilocarpine

insert in the columns in the order indicated:

Polyethylene glycol 400

In respect of the eye drops 2.5 mg per mL, 15 mL:

Severe dry eye syndrome, including Sjogren's syndrome

In respect of the eye drops 2.5 mg per mL, single dose units 0.4 mL, 20:

In compliance with authority procedures set out in subparagraph 14 (d):

Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops

1. Schedule 2A, omit item dealing with Tamarindus indica seed polysaccharide

1. Schedule 3, after item dealing with Amoxycillin

insert in the columns in the order indicated:

Artemether Artemether with Lumefantrine

1. Schedule 3, item dealing with Aspirin

insert above existing text in the column headed “Allowable compounds”:

Clopidogrel with Aspirin

1. Schedule 3, after item dealing with Benserazide

insert in the columns in the order indicated:

Betamethasone Calcipotriol with Betamethasone

1. Schedule 3, after item dealing with Buprenorphine

insert in the columns in the order indicated:

Calcipotriol Calcipotriol with Betamethasone

1. Schedule 3, after item dealing with Clavulanic Acid

insert in the columns in the order indicated:

Clopidogrel Clopidogrel with Aspirin

1. Schedule 3, after item dealing with Lopinavir

insert in the columns in the order indicated:

Lumefantrine Artemether with Lumefantrine

1. Schedule 6, after item dealing with Adefovir

insert:

Ambrisentan