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ADEC 201st meeting resolutions, 4-5 February 1999

Australian Drug Evaluation Committee

4 February 1999

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 201st (1999/1) Meeting of the Australian Drug Evaluation Committee (ADEC) (4-5 February 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 drugs 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.

CAMPRAL Acamprosate calcium tablets 333 mg
Alphapharm Pty Limited
Indications: For therapy to maintain abstinence in alcohol-dependent patients, to be combined with counselling.

ZOFRAN Ondansetron hydrochloride tablets 24 mg
Glaxo Wellcome Australia Ltd
Indications: For the prevention of nausea and vomiting induced by highly emetogenic chemotherapy.

DILAUDID Hydromorphone hydrochloride oral solution (1 mg/mL); tablets (2 mg, 4 mg and 8 mg); injection (2 mg/mL and 10 mg/mL)
Knoll Australia Pty Limited
Indications: For the treatment of moderate to severe pain.

ZITHROMAX Azithromycin capsules (250 mg), tablets (250 mg and 500 mg) and powder for oral suspension
Pfizer Pty Limited
Indications: For the treatment of Chlamydia Trachomatis conjunctivitis or trachoma.

DETRUSITOL Tolterodine L-tartrate tablets 1mg and 2 mg
Pharmacia & Upjohn Pty Limited
Indications: For the treatment of patients with overactive bladder (eg, symptoms of urinary frequency, urgency or incontinence or any combination of these symptoms).

XELODA Capecitabine tablets 150 mg and 500 mg
Roche Products Pty Limited
Indications: For the treatment of patients with locally advanced or metastatic breast cancer after failure of paclitaxel and an anthracycline-containing chemotherapy regimen unless therapy with these and other standard agents are clinically contraindicated.

CYMEVENE Ganciclovir capsules 250 mg
Roche Products Pty Limited
Indications: For the primary prophylaxis of Cytomegalovirus (CMV) disease in liver transplant recipients at risk of CMV disease.

CYMEVENE Ganciclovir powder for injection 500 mg
Roche Products Pty Limited
Indications: For the primary prophylaxis of Cytomegalovirus disease in liver, heart and bone marrow transplant patients at risk for Cytomegalovirus disease.

NOVONORM Repaglinide tablets 0.5 mg, 1 mg and 2 mg
Novo Nordisk Pharmaceuticals Pty Limited
Indications: For the treatment of Type 2 diabetes or non-insulin dependent diabetes mellitus.

THROMBOTROL-VF Human Anti-thrombin III concentrate powder for injection 1000 IU/per vial
CSL Limited
Indications: For use in patients with hereditary deficiency of anti-thrombin III for the prevention and therapeutic treatment of thrombosis and pulmonary emboli during surgery, pregnancy and childbirth.

COPAXONE Glatiramer acetate powder for injection 20 mg
Hoechst Marion Roussel Australia Pty Ltd
Indications: For reducing the frequency of relapses in patients with relapsing-remitting multiple sclerosis.

FLIXOTIDE NEBULES Fluticasone propionate suspension for inhalation 0.5 mg/2mL and 2 mg/2mL
Glaxo Wellcome Australia Ltd
Indications: For the treatment of severe asthma in adults and adolescents over 16 years.

FLIXOTIDE INHALER metered dose CFC inhalers 25 µg and 50 µg
Glaxo Wellcome Australia Ltd
Indications: For the prophylactic management of asthma in children aged one to four years.

RELENZA Zanamavir powder for inhalation 5 mg
Glaxo Wellcome Australia Ltd
Indications: For the treatment of infections due to influenza A or B viruses in adults and children aged 12 years and older.

URSOFALK Ursodeoxycholic acid capsules 250 mg
Orphan Australia Pty Limited
Indications: For the treatment of chronic cholestatic liver disease.

ATROVENT NASAL PLUS Ipratropium nasal spray solution 0.6 mg/mL
Boehringer Ingelheim Pty Limited
Indications: For the symptomatic relief of rhinorrhoea associated with allergic and non-allergic perennial rhinitis and the common cold.

ATROVENT NASAL PLUS Ipratropium 0.3 mg/mL
Boehringer Ingelheim Pty Limited
Indications: To include symptomatic relief of rhinorrhoea associated with the common cold.

AGGRASTAT Tirofiban hydrochloride solution for intravenous infusion 0.05 mg/mL and concentrate 0.25 mg/mL
Merck Sharp & Dohme (Australia) Pty Limited
Indications: For the treatment of unstable angina and non Q-wave myocardial infarction to prevent cardiac ischaemic events.

PHARMORUBICIN Epirubicin hydrochloride solution and powder for injection 10 mg, 20 mg, 50 mg, 150 mg and 200 mg
Pharmacia & Upjohn Pty Limited
Indications: To include adjuvant treatment in early breast cancer.

ZEFFIX Lamivudine tablets and oral solution 100 mg and 5 mg/mL
Glaxo Wellcome Australia Ltd
Indications: For the treatment of patients 16 years of age or older with chronic hepatitis B and evidence of hepatitis B virus (HBV) replication.

NIMBEX Cisatracurium besylate injection 5 mg/2.5 mL, 10 mg/5 mL, 20 mg/10 mL, 50 mg/25 mL and 150 mg/30 mL
Glaxo Wellcome Australia Ltd
Indications: For use in paediatric patients aged one month to two years; for tracheal intubation in children aged one month to 12 years; and to increase the maximum dose in patients undergoing Coronary Artery Bypass Graft (CABPG) surgery to 0.4 mg/kg by rapid intravenous bolus injection.

CLIMEN 28 Oestradiol valerate and Oestradiol valerate/Cyproterone acetate tablets
Schering Pty Limited
Indications: For the treatment of symptoms related to the menopause and for oestrogen deficiency symptoms after ovariectomy for non-carcinomatous disease.

INFANRIX-HB Diphtheria/Tetanus Toxoid/Acellular Pertussis and Hepatitis B sterile suspension for injection
SmithKline Beecham (Australia) Pty Ltd
Indications: For use in primary immunisation and as a first booster dose for children previously immunised with primary courses of diphtheria, tetanus, pertussis and hepatitis B vaccines.

REZULIN Troglitazone tablets 200 mg and 400 mg
Parke Davis Pty Ltd
Indications: For the treatment of Type II diabetes mellitus where insulin does not provide adequate glycaemic control.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

9 March 1999

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