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ADEC 203rd meeting resolutions, 3-4 June 1999

Australian Drug Evaluation Committee

3 June 1999

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 203rd (1999/3) Meeting of the Australian Drug Evaluation Committee (ADEC) (3-4 June 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.

OMNIC Tamsulosin hydrochloride modified release capsules 400 µg
CSL Limited
Indications: For the treatment of benign prostatic hyperplasia.

CELEBREX Celecoxib hard gelatin capsules 100 mg and 200 mg
Searle, Division of Monsanto Australia Limited
Indications: For the symptomatic treatment of osteoarthritis and rheumatoid arthritis.

CELLCEPT Mycophenolate mofetil powder for IV infusion 500 mg
Roche Products Pty Limited
Indications: For the prophylaxis of organ rejection in adults receiving allogeneic cardiac or renal transplants.

TAXOTERE Docetaxel concentrated solution for IV infusion, 20 mg/0.5mL and 80 mg/2 mL
Rhone-Poulenc Rorer Australia Pty Ltd
Indications: To include the treatment of metastatic carcinoma of the ovary after failure of first-line or subsequent chemotherapy.

PRAVACHOL Pravastatin sodium tablets 5, 10, 20 and 40 mg
Bristol-Myers Squibb Pharmaceuticals Pty Ltd
Indications: To include the treatment of patients with unstable angina pectoris (see clinical trials).

MICARDIS/PRITOR Telmisartan tablets 40 mg and 80 mg
Boehringer Ingelheim Pty Limited
Indications: For the treatment of mild to moderate hypertension.

OXYCONTIN Oxycodone hydrochloride modified release tablets 10, 20, 40 and 80 mg
Mundipharma Pty Ltd
Indications: For the management of chronic severe pain unresponsive to non-narcotic analgesia.

BONDRONAT Ibandronic acid concentrate for IV infusion 1 mg/mL and 2 mg/2 mL ampoules
Roche Products Pty Limited
Indications: For the treatment of tumour-induced hypercalcaemia, with or without metastases.

ACCUPRIL Quinapril hydrochloride tablets 5, 10 and 20 mg
Parke Davis Pty Limited
Variation: A new dose regimen for the treatment of heart failure.

ARAVA Leflunomide tablets 10, 20 and 100 mg
Hoechst Marion Roussel Australia Pty Limited
Indications: For the treatment of active rheumatoid arthritis.

TILADE CFC-FREE Nedocromil sodium metered dose pressurised aerosol 2 mg/actuation
Rhone-Poulenc Rorer Australia Pty Ltd
Indications: Prophylaxis of mild to moderate persistent asthma in adults; prophylaxis of frequent episodic asthma in children aged over two years; and prevention of bronchospasm provoked by exercise, cold air, inhaled allergens, atmospheric pollutants and other irritants.

MONOPLUS 10/12.5 and MONOPLUS 20/12.5 Fosinopril sodium and hydrochlorothiazide fixed combination tablets
Bristol Myers Squibb Australia Pty Ltd
Indications: For the treatment of mild to moderate hypertension. Treatment should not be initiated with this combination.

INTEGRILIN Eptifibatide solution for injection 20 mg/10 mL and 75 mg/100 mL vials
Schering Plough Pty Ltd
Indications: For the treatment of patients presenting with unstable angina.

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INTRAMUSCULAR IMMUNOGLOBULIN PRODUCTS Normal Immunoglobulin Viral Inactivated, Hepatitis B Immunoglobulin Viral Inactivated, Rh(D) Immunoglobulin Viral Inactivated, Tetanus Immunoglobulin Viral Inactivated, Zoster Immunoglobulin Viral Inactivated, injection
CSL Limited
Variation: Approval of a change to the manufacturing process. The indications and dosage recommendations for each of these products should be identical to the current registrations.

CABASER Cabergoline tablets 1, 2 and 4 mg
Pharmacia & Upjohn Pty Limited
Indications: To include treatment of Parkinson's disease (see clinical trials).

COSOPT Dorzolamide hydrochloride and timolol maleate eye drops 20 mg/mL and 5 mg/mL
Merck Sharp & Dohme (Australia) Pty Limited
Indications: For the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate.

BETAFERON Interferon beta-1b injection 0.3 mg/vial
Schering Pty Limited
Indications: To include the treatment of progressive multiple sclerosis.

STEMGEN Ancestim powder for injection 1.875 mg and 2.5 mg vials
Amgen Australia Pty Ltd
Indications: For use in combination with Neupogen (filgrastim) in the setting of autologous peripheral blood progenitor cells (PBPC) transplantation for patients at risk of poor PBPC mobilisation, to increase the number of PBPC collected in the apheresis harvest, thereby increasing the proportion of patients reaching a PBPC target for transplantation.

PENTAVAX Diptheria/Tetanus/Whole Cell Pertussis/H. Influenzae Type B/ Hepatitis B combined vaccine injection 0.5 mL
Merck Sharp & Dohme (Australia) Pty Limited
Indications: For use in infants whose mothers are hepatitis B surface antigen-negative and who have been given an injection of hepatitis B vaccine within seven days of birth.

TOPAMAX Topiramate sprinkle capsules 15, 25 and 50 mg
Janssen-Cilag Pty Ltd
Indications: To include partial onset epileptic seizures, with or without secondary generalisation, inadequately controlled by first-line anti-epileptic medications and treatment for drop attacks associated with the Lennox-Gastaut syndrome, in patients two years or older.

ULTRAVIST Iopromide solution for injection 0.623 g/mL and 0.769 g/mL
Schering Pty Limited
Indications: To include paediatric use in contrast enhanced computerised tomography, intravenous urography and angiocardiography.

ZAVEDOS Idarubicin hydrochloride solution for injection 5 mg/5mL, 10 mg/10 mL and 20 mg/20 mL
Pharmacia & Upjohn Pty Limited
Variation: New dosage form and altered dosing in hepatic and renal impairment.

VARILRIX Varicella live attenuated vaccine injection 103.3 plaque forming units varicella-zoster virus (OKA strain)/0.5 mL
SmithKline Beecham Australia Pty Ltd
Indications: For active immunisation of healthy subjects from nine months of age against varicella.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

June 1999

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