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ADEC 211th meeting resolutions, 3-4 August 2000

Australian Drug Evaluation Committee

3 August 2000

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 211th (2000/4) meeting of the Australian Drug Evaluation Committee (ADEC) (3-4 August 2000) resolved to advise the Parliamentary Secretary to the Minister for Health and Aged Care and the Secretary, Department of Health and Aged Care 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.

CLEXANE Enoxaparin sodium
Sterile solution for subcutaneous injection, 100 mg/mL in 0.2 mL, 0.4 mL, 0.6 mL, 0.8 mL and 1.0 mL syringes, 0.2 mL and 0.4 mL cartridges and 1 mL ampoules, 150 mg/mL in 0.8 mL and 1.0 mL syringes
Rhône-Poulenc Rorer Australia Pty Ltd
Variation: To extend the Indication to include prophylaxis of venous thromboembolism in medical patients bedridden due to acute illness.

ATACAND PLUS 16/12.5 Candesartan cilexetil/hydrochlorothiazide
Capsules containing16 mg candesartan cilexetil, and 12.5 mg hydrochlorothiazide
AstraZeneca Pty Ltd
Variation: A new fixed dose combination for the treatment of hypertension.

OXYNORM Oxycodone hydrochloride
Capsules, 5 mg, 10 mg and 20 mg
Mundipharma Pty Limited
Variation: New dose form for the management of opioid-responsive, moderate to severe pain.

PARIET Rabeprazole sodium
Tablets, 10 mg and 20 mg
Janssen-Cilag Pty Ltd
Indication: For the treatment and prevention of relapse of gastro-oesophageal reflux disease, treatment of duodenal ulcers, and treatment of gastric ulcers.

AROMASIN Exemestane
Tablets, 25 mg
Pharmacia & Upjohn Pty Limited
Indication: For the treatment of advanced breast cancer in women with natural or induced post-menopausal status whose disease has progressed following anti-oestrogen therapy.

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BEROMUN Tasonermin
Sterile powder for intra-arterial injection, 1 mg per vial
Boehringer Ingelheim Pty Limited
Indication: For use in mild hyperthermic isolated limb perfusion, as an adjunct to surgery for subsequent removal of soft tissue sarcomas of the limbs so as to prevent or delay amputation; and in the palliative situation, for irresectable soft tissue sarcomas of the limbs.

BONEFOS Sodium clodronate tetrahydrate
Tablets, 400 mg and 800 mg, Capsules, 400 mg
Aventis Pharma Pty Limited
Variation: To extend the Indication to include the treatment of osteolytic bone metastases due to carcinoma of the breast and the treatment of osteolytic lesions of multiple myeloma.

ARIMIDEX Anastrozole
Tablets, 1 mg
AstraZeneca Pty Ltd
Variation: To extend the Indications to include first line treatment of advanced breast cancer in post-menopausal women with oestrogen and/or progesterone receptor-positive disease.

LUCRIN DEPOT Leuprorelin acetate
Sterile powder for intramuscular injection containing leuprorelin acetate 30 mg, plus sterile water for injection, 2 mL
Abbott Australasia Pty Ltd
Variation: For the palliative treatment of metastatic or locally extensive prostatic cancer.

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LANTUS Insulin glargine
Sterile solution for subcutaneous injection, 100 IU/mL in 5 mL and 10 mL vials, and 3 mL cartridges
Aventis Pharma Pty Limited
Indication: For the treatment of Type I or Type II diabetes mellitus in adults who require insulin for the control of hyperglycaemia.

NORDITROPIN/NORDITROPIN SIMPLEXx Somatropin
Sterile powder for reconstitution for injection containing, Somatropin 4 mg in vials, or 4 mg and 8 mg in cartridges, Norditropin SimpleXx sterile solution for injection, Somatropin 5 mg, 10 mg and 15 mg in cartridges
Novo Nordisk Pharmaceuticals Pty Ltd
Variation: To extend the Indication to include treatment of growth failure in girls due to gonadal dysgenesis (Turner Syndrome); and treatment of growth failure in children due to chronic renal insufficiency.

TRILEPTAL Oxcarbazepine
Tablets, 150 mg, 300 mg and 600 mg
Novartis Pharmaceuticals Australia Pty Ltd
Indication: For use as monotherapy or adjunctive therapy for the treatment of partial and generalised tonic-clonic seizures, in adults and children.

SERC Betahistine dihydrochloride
Tablets, 16 mg
Solvay Pharmaceuticals
Variation: To increase the maximum daily dose from 32 mg to 48 mg for the treatment of Meniere's Syndrome.

RELPAX Eletriptan hydrochloride
Tablets, 20 mg, 40 mg and 80 mg
Pfizer Pty Limited
Indication: For the acute treatment of migraine headache, with or without aura.

PERSANTIN Dipyridamole
Sterile solution for intravenous injection, 10 mg/2 mL
Boehringer Ingelheim Pty Limited
Variation: To include use as an alternative to exercise in myocardial imaging.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

21 August 2000

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