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ADEC 238th meeting resolutions, 3-4 February 2005

Australian Drug Evaluation Committee

3 February 2005

Published in the Commowealth of Australia Gazette, No. GN 8, 2 March 2005

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 238th (2005/1) meeting of the Australian Drug Evaluation Committee (ADEC) (3-4 February 2005) 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.

PREGABALIN 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, and 300mg
Lyrica
Capsules
Pfizer Australia Pty Ltd.
New Chemical Entity: As adjunctive therapy in adults with partial seizures with or without secondary generalisation. Treatment of neuropathic pain.

RISPERIDONE 250µg, 500µg, 1mg, 2mg, 3mg, 4mg and 6mg; 1mg/mL; 0.5mg, 1mg and 2mg
Risperdal
Tablets, Oral liquid and orally disintegrating tablet
Janssen-Cilag Pty Ltd
New Indication: For the treatment of behavioural disorders associated with autism in children and adolescents.

MESALAZINE 500mg
Salofalk
Enteric coated tablets
Orphan Australia Pty Ltd
New Indication: For the treatment of acute episodes and maintenance of remission of Crohn's ileitis and colitis.

ABACAVIR (as SULFATE) AND LAMIVUDINE 600mg / 300mg
Kivexa
Tablets
GlaxoSmithKline Australia Pty Ltd
New Fixed Combination: For the treatment of Human Immunodeficiency Virus (HIV) infection in adults and children over 12 years of age in combination with other antiretrovirals.

VALSARTAN AND HYDROCHLOROTHIAZIDE 80mg/12.5mg, 160mg/12.5mg and 160mg/25mg
Co-Diovan
Tablets
Novartis Pharmaceuticals Australia Pty Ltd
New Fixed Combination: For the treatment of hypertension. Treatment should not be initiated with these combinations.

CANDESARTAN CILEXETIL 4mg, 8mg and 16mg
Atacand
Tablets
Astra Zeneca Pty Ltd
New Indication: Treatment of patients with heart failure and left ventricular systolic dysfunction. Treatment with Atacand reduces mortality due to heart failure and reduces hospitalisation due to heart failure, in patients with left ventricular ejection function less than 40%, and improves symptoms.

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DOCETAXEL 20mg and 80mg
Taxotere
Concentrated Injection
Aventis Pharma Pty Limited
New Indication: For treatment of patients with androgen independent (hormone refractory) prostate cancer.

ETANERCEPT 25mg
Enbrel
Powder for Injection
Wyeth Australia Pty Limited
New Indication: Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to, other systemic therapy including cyclosporin, methotrexate or PUVA. Safety and efficacy beyond 12 months have not been demonstrated.

TEMOZOLOMIDE 5mg, 20mg, 100mg and 250mg
Temodal and Temoxol
Capsules
Schering Plough Pty Limited
Change in Patient Group: Treatment of recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy.

GLUCOSE, CALCIUM CHLORIDE,MAGNESIUM CHLORIDE, SODIUM BICARBONATE, SODIUM LACTATE, SODIUM CHLORIDE (1.36%, 2.27% and 3.86% final glucose concentrations)
Physioneal 40
Solution for peritoneal dialysis
Baxter Healthcare Pty Ltd
New Fixed Combination: For use in peritoneal dialysis in patients with acute or chronic renal failure.

AZELASTINE HYDROCHLORIDE 0.05%
Eyezep
Eye Drops
Sigma Pharmaceuticals Pty Ltd
New Route of Administration: Treatment and prevention of the symptoms of seasonal and non-seasonal (perennial) allergic conjunctivitis in adults and children 4 years and older.

16 February 2005

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