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ADEC 248th meeting resolutions, 6 October 2006

Australian Drug Evaluation Committee

6 October 2006

Published in the Commonwealth of Australia Gazette, No. GN 44, 8 November 2006

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 248th (2006/5) meeting of the Australian Drug Evaluation Committee (ADEC) (6 October 2006) 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.

RESOLUTION NO 8999

  1. There should be no objection to approval of the submission from Baxter Healthcare Pty Ltd to register FEIBA-NF powder for injection containing the new biological entity Factor Eight Inhibitor Bypassing Fraction 500 IU and 1,000 IU for the indication:
    Second line therapy for the control of spontaneous bleeding episodes and use in surgery, in haemophilia A or B patients with inhibitors, for whom recombinant human factor VIIa is unavailable or has failed.
  2. Use should be contraindicated in extracorporeal membrane oxygenation (ECMO) or cardiac surgery involving cardiopulmonary bypass.

RESOLUTION NO 9001

  1. There should be no objection to approval of the submission from Novartis Pharmaceuticals Australia Pty Ltd to register a new dosage regimen and new strength for DIOVAN film coated tablets containing valsartan 320mg for the indication:
    Treatment of hypertension.

RESOLUTION NO 9005

  1. There should be no objection to approval of the submission from Galderma Australia Pty Ltd to register METVIX cream containing methyl aminolevulinate 160mg/g, in association with photodynamic therapy, for the indication:
    Treatment of biopsy proven squamous cell carcinoma in situ (Bowen's disease) where surgery is considered inappropriate.