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ADEC 196th meeting resolutions, 2-3 April 1998

Australian Drug Evaluation Committee

2 April 1998

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 196th (1998/2) Meeting of the Australian Drug Evaluation Committee (ADEC) (2-3 April 1998) resolved to advise the Parliamentary Secretary to the Minister for Health and Family Services, and the Secretary, Department of Health and Family Services, 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.

FLUTICASONE PROPIONATE, Flixotide Inhaler CFC-Free Powder for inhalation; 125 µg/actuation and 250 µg/actuation
Glaxo Wellcome Australia Pty Ltd
Indications: For use in the prophylactic management of asthma in adults and children over 4 years of age.

DISODIUM ETIDRONATE (AND CALCIUM CARBONATE), Didrocal tablets 200 mg (and 1.25 g)
Pharmacia & Upjohn Pty Limited
Indication: For the treatment of osteoporosis. Osteoporosis must be confirmed by the finding of low bone mass (at least 2 standard deviations below the gender-specific mean for young adults) or by the presence or history of osteoporotic fracture.

CANDESARTAN CILEXETIL, Atacand tablets 4 mg, 8 mg and 16 mg mesylate, Trovan IV 5mg/mL
Astra Pharmaceuticals Pty Ltd
Indication: The treatment of mild to moderate hypertension.

EPOIETIN ALFA, Eprex sterile solution for injection 2000, 4000 and 10000 IU/mL
Janssen-Cilag Pty Ltd
Indications: Eprex is also indicated for the prevention and treatment of anaemia in patients with non-myeloid malignancies, where anaemia is anticipated to develop or develops as a result of concomitantly administered chemotherapy. Eprex is indicated to decrease the need for transfusion in patients who will continue to receive concomitant chemotherapy for a minimum of two months.

RALTITREXED, omudex Lyophilised powder for reconstitution of solution for injection 2 mg/vial
ICI Australia Operations Pty Ltd
Indications: For use as a single agent in the palliative treatment of advanced colorectal cancer (distant metastases or unresectable local disease).

AMPHOTERICIN B, Abelcet sterile concentrate for injection 5 mg/mL
Pharmaction Pty Ltd (on behalf of the Liposome Company)
Indications: For the treatment of invasive fungal disease caused by organisms susceptible to ampohotericin B.

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TRANDOLAPRIL, Odrik/Gopten capsules 0.5 mg, 1 mg, 2 mg
Hoechst Marion Roussel Australia Pty Ltd (Odrik) and Knoll Australia Pty Ltd (Gopten)
Indications: Left Ventricular Dysfunction Post-Myocardial Infarction: ODRIK [GOPTEN] is also indicated for patients with left ventricular dysfunction [£ 35% ejection fraction].

SAQUINAVIR, Fortovase soft gelatin capsules 200 mg
Roche Products Pty Ltd
Indications: For use in combination with other antiretroviral agents in the treatment of HIV infection.

ENALAPRIL MALEATE, Renitec wafers 2.5 mg, 5 mg, 10 mg and 20 mg
Merck Sharpe & Dohme (Australia) Pty Ltd
Indications: For the treatment of all grades of hypertension, congestive heart failure and left ventricular dysfunction.

LENOGRASTIM, Granocyte 13 and Granocyte 34 powder for reconstitution of solution for injection 33.6 million IU/vial (Granocyte 34) and 13.4 million IU/vial (Granocyte 13)
Amrad Operations Pty Ltd
Indications: Granocyte is also indicated to mobilise peripheral blood progenitor cells (PBPC) either alone or after myelosuppressive chemotherapy, in order to accelerate haematopoietic recovery by infusion of PBPC after myelosuppression or myeloablative therapy in patients with non-myeloid malignancies. Granocyte is also indicated to accelerate the engraftment of PBPC after their re-infusion.

PACLITAXEL, Taxol sterile concentrated soution for injection 30 mg/5 mL, 100 mg/16.7 mL and 150 mg/25 mL
Bristol-Myers Squibb Pharmaceuticals Pty Ltd
Indications: For the treatment of non-small cell lung cancer (NSCLC).

SIMVASTATIN, Zocor/Lipex film coated tablets 5 mg, 10 mg, 20 mg and 40 mg
Merck Sharpe & Dohme (Australia) Pty Ltd (Zocor); Amrad Operations Pty Ltd (Lipex)
Indications: As an adjunct to diet for treatment of hypercholesterolaemia.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

14 April 1998

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