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ADEC 206th meeting resolutions, 7-8 October 1999

Australian Drug Evaluation Committee

7 October 1999

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 206th (1999/6) meeting of the Australian Drug Evaluation Committee (ADEC) (7-8 October 1999) 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.

FLIXONASE Fluticasone propionate
Nasal spray, 50 mg/actuation
Glaxo Wellcome Australia Ltd
Indications: For the prophylaxis and treatment of seasonal allergic rhinitis and for the treatment of perennial rhinitis.

NEURONTIN Gabapentin
Capsules, 100 mg, 300 mg and 400 mg
Parke Davis Pty Ltd
Variation: To vary the regimen for dosage initiation to 900 mg per day for the treatment of partial seizures, including secondarily generalised tonic-clonic seizures, to be used as add-on therapy in those patients who have not achieved adequate control with standard anti-epileptic drugs.

NEURONTIN Gabapentin
Tablets, 600 mg and 800 mg
Parke Davis Pty Ltd
Variation: New strength tablets for the currently registered indication.

PREDONIUM DS Perindopril/indapamide
Tablets, 4 mg/1.25 mg
Servier Laboratories (Australia) Pty Ltd
Indications: For the treatment of mild to moderate hypertension. Treatment should not be initiated with this fixed dose combination.

OMNISCAN Gadodiamide
Injection, 287 mg/mL in 5 mL, 10 mL, 15 mL and 20 mL ampoules/vials
Nycomed Australia Pty Ltd
Variation: To extend the approved indications to include enhancement of magnetic resonance imaging of the whole body, to increase the dose for contrast enhancement of magnetic resonance imaging of the central nervous system in adults, and to remove the contraindication for use in patients with impaired renal function.

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AGRYLIN Anagrelide
Capsules, 0.5 mg and 1 mg
Orphan Australia Pty Ltd
Indications: For the treatment of essential thrombocythaemia.

HYZAAR/HYZAAR DS Losartan/hydrochlorothiazide
Tablets, 50 mg/12.5 mg and 100 mg/25 mg
Merck Sharp & Dohme (Australia) Pty Limited
Indications: For the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination.

CORVERT Ibutilide fumarate
Solution for intravenous infusion, 1 mg/10 mL
Pharmacia & Upjohn Pty Limited
Indications: For the acute conversion of atrial fibrillation or atrial flutter to sinus rhythm, as an alternative to electrical cardioversion.

ROFERON-A Interferon alfa-2a
Solution for injection, 3, 4, 5, 6 and 9 million units in prefilled syringes and 18 million units per vial
Roche Products Pty Limited
Variation: To extend the indications to include the treatment of advanced renal cell carcinoma.

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UBIT 13C-urea
Granules for oral solution, 100 mg
Otsuka Pharmaceutical Australia Pty Ltd
Indications: For use as a breath test for the in vivo diagnosis of gastro-duodenal Helicobacter pylori infection.

SOMAC/PROTAN Pantoprazole sodium
Tablets, 20 mg
Pharmacia & Upjohn Pty Ltd
Variation: For the acute treatment of reflux oesophagitis and the prevention of relapse of moderate to severe reflux oesophagitis in adults. To extend the approved indications for Somac/Protan 40 mg tablets to include the prevention of relapse of moderate to severe reflux oesophagitis in adults.

SEROQUEL Quetiapine fumarate
Tablets, 25 mg, 100 mg and 200 mg
AstraZeneca
Indications: For the treatment of schizophrenia.

KARVEZIDE/AVAPRO HCT Irbesartan/hydrochlorothiazide
Tablets, 150 mg/12.5 mg and 300 mg/12.5 mg
Sanofi-Synthelabo Australia Pty Limited/Bristol-Myers Squibb Australia Pty Ltd
Indications: For the treatment of mild to moderate hypertension in patients whose blood pressure is not satisfactorily controlled on irbesartan or hydrochlorothiazide alone. Treatment should not be initiated with this fixed-dose combination.

VIOXX Rofecoxib
Tablets, 12.5 mg and 25 mg. Oral suspension, 12.5 mg/5 mL and 25 mg/5 mL
Merck Sharp & Dohme (Australia) Pty Limited
Indications: For the symptomatic treatment of osteoarthritis.

RISPERDAL Risperidone
Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg. Oral solution, 1 mg/mL
Janssen-Cilag Pty Ltd
Variation: To extend the approved indications to include the treatment of behavioural disturbances in dementia.

NEUROLITE Technetium 99mTc-bicisate
Injection kit
Du Pont (Australia) Ltd
Indications: For the evaluation and localisation of regional perfusion abnormalities in adult patients with the central nervous system disorders of stroke and dementia.

LOSEC/ACIMAX Omeprazole magnesium
Tablets (as magnesium), 10 mg, 20 mg and 40 mg
Astra Pharmaceuticals Pty Ltd
Variation: To extend use to include the treatment of paediatric patients aged one year and older.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

27 October 1999

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