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ADEC 227th meeting resolutions, 3-4 April 2003

Australian Drug Evaluation Committee

3 April 2003

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 227th (2003/2) meeting of the Australian Drug Evaluation Committee (ADEC) (3-4 April 2003) resolved to advise the Parliamentary Secretary to the Minister for Health and Ageing and the Secretary, Department of Health and Ageing that the following medicines should be approved for registration, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the Therapeutic Goods Administration. These recommendations for approval may be subject to specific conditions.

DISODIUM ETIDRONATE & CALCIUM CARBONATE - Didrocal
Disodium Etidronate 200mg Uncoated Tablets /Calcium Carbonate 1.25g Film-Coated Tablets
Pharmacia Australia Pty. Ltd.
Variation: Extension of the registered indication to include: Prevention of bone loss in patients for whom long-term treatment with high-dose corticosteroids is either about to be commenced or has been recently initiated.

PIMECROLIMUS Elidel®
Cream containing the new chemical entity pimecrolimus 1% w/v
Tubes, 15g, 30g and 100g tubes
Novartis Pharmaceuticals Australia Pty Ltd
Indication: For infants (3-23 months), children (2-11 years), adolescents (12-17 years), and adults with atopic dermatitis (eczema) for:

  1. the short-term treatment of signs and symptoms and
  2. intermittent long-term use in the treatment of incipient and resolving lesions in atopic dermatitis where the use of a corticosteroid is not yet warranted or no longer needed.

INSULIN ASPART (RYS) Novorapid
Sterile solution for injection, 100IU/mL injection multidose vial (10ml vial) for intravenous use.
Novo Nordisk Pharmaceuticals Pty Ltd
Variation: Registration of a new route of administration and addition of an indication to include: a claim of reduced incidence of nocturnal hypoglycaemia

PANTOPRAZOLE Somac™ and Pantoloc™
Tablets, 20mg containing the new chemical entity pantoprazole
Pharmacia Australia Pty Limited
Variation: Extension of indications to include the prevention of gastroduodenal lesions and dyseptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in 'increased risk' patients with a need for continuous non-selective NSAID treatment.

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GALANTAMINE Reminyl™
Tablets, 4mg, 8mg, 12mg, Oral Solution 4mg/mL
Janssen-Cilag Pty Ltd
Variation: Changes to the clinical aspects of the Product Information (PI) to include the proposed statement in the clinical trials section from study GAL-INT-6 as amended by the Clinical Evaluator which should include information indicating that the trial showed that Reminyl had no effect in patients with vascular dementia.

ARIPIPRAZOLE Abilify
Tablets, 2mg, 5mg, 10mg, 15mg, 20mg, and 30mg containing the new chemical entity aripiprazole.
Bristol Myers Squibb Australia P/L
Indication: For the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.

PEGINTERFERON ALFA-2a Pegasys®
Sterile solution for injection, 135 µg and 180 µg in vials and prefilled syringes.
PEGINTERFERON ALFA-2a Pegasys-RBV™
Combination packs consisting of peginterferon alfa-2a (Pegasys®) solution for injection 135 µg and 180 µg in prefilled syringes + ribavirin Copegus™ 200 mg tablets
Roche Products Limited
Indication: For the treatment of chronic hepatitis C alone or in combination with ribavirin in patients who have received no prior interferon therapy.

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INTERFERON ALFA-2A Roferon®-A
Sterile solution for injection in pre-filled syringes containing 3 MIU, 4 MIU, 5 MIU, 6 MIU, or 9 MIU
Roche Products Pty Limited
Variation: Extension of indication to include the treatment of chronic hepatitis C in combination with ribavirin in previously untreated patients or patients who have relapsed after interferon alfa monotherapy. Patients must be 18 years of age or older and have compensated liver disease.

RIBAVIRIN Copegus
Tablets containing 200 mg ribavirin
Roche Products Pty Limited
Variation: New dose form of ribavirin, containing ribavirin 200 mg to be used in combination with interferon alfa agents for the treatment of chronic hepatitis C. Patients must be 18 years of age or older and have compensated liver disease.

DIMEGLUMINE GADOPENTETATE Magnevist
Sterile solution for injection in prefilled syringes, 2 mmol/L
Schering Pty Limited
Variation: New strength for contrast enhancement in magnetic resonance arthrography.

OSELTAMIVIR PHOSPHATE TAMIFLU
Sterile powder for oral suspension 12 mg/mL
Roche Products Pty Ltd
Variation: New dosage form and extension of patient population for the treatment of infections due to influenza A and B viruses in adults and children aged 1 year and older.

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ANAKINRA KineretTM
Sterile solution for injection in prefilled syringes 100 mg/0.67 mL
Amgen Australia Pty Ltd
Indication: For the treatment of active adult rheumatoid arthritis (RA) in patients who have had inadequate response to one or more other Disease Modifying Anti Rheumatic Drugs (DMARDs).

APOMORPHINE Uprima
Tablets, 2 mg and 3 mg tablets
Abbott Australasia Pty Ltd
Indication: For the treatment of erectile dysfunction.

EZETIMIBE Ezetrol™
Tablets, 10 mg
Merck Sharp and Dohme (Australia) Pty Limited
Indication: For the treatment of:

  • Homozygous Familial Hypercholesterolaemia.
    Ezeterol, in combination with a statin, is indicated for the treatment of homozygous familial hypercholesterolaemia.
  • Homozygous Sitosterolaemia (Phytosterolaemia).
    Ezeterol is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial hypercholesterolaemia.

GEFITINIB Iressa
Tablets, 250 mg
AstraZeneca Pty Ltd
Indication: For the treatment of patients with locally advanced or metastatic non-small cell lung cancer who have previously received chemotherapy.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

16 April 2003

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GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The ADEC Reference Panel of the Australian Drug Evaluation Committee (ADEC) (5 March 2003) resolved to advise the Parliamentary Secretary to the Minister for Health and Ageing and the Secretary, Department of Health and Ageing that the following medicines should be approved for registration, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the Therapeutic Goods Administration. This recommendation for approval may be subject to specific conditions.

Alendronate sodium - FOSAMAX®
5mg, 10mg, 40mg, 70mg tablets
Merck Sharp and Dohme (Australia) Pty Ltd
Variation: The recommended treatment regimen is 40mg once a day for up to six months.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

24 March 2003

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