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ADEC 259th meeting resolutions, 1 August 2008
Australian Drug Evaluation Committee
Published in the Commonwealth of Australia Gazette, No. GN 37, 17 September 2008
THERAPEUTIC GOODS ACT 1989
AUSTRALIAN DRUG EVALUATION COMMITTEE
The 259th (2008/4) meeting of the Australian Drug Evaluation Committee (ADEC) (1 August 2008) 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.
There should be no objection to approval of the submission from Schering-Plough Pty Limited to register Product Information changes to include the clinical trial results of the IMPACT-2 study for REMICADE powder for injection containing infliximab 100 mg.
The submission from Wyeth Australia Pty Limited to register Product Information changes to TYGACIL Powder for Injection containing tigecycline 50 mg to include data in relation to Methicillin-Resistant Staphylococcus Aureus (MRSA), Vancomycin-Resistant Enterococcus (VRE) and Resistant Gram-Negative Pathogens but not Rapidly Growing Mycobacterial Infections should be included in the PI.
There should be no objection to approval of the submission from Sanofi-Aventis Australia Pty Ltd to register a new dose regimen for TAXOTERE powder for injection containing docetaxel 40 mg/mL (when reconstituted) for use:
in combination with cisplatin and fluorouracil as induction treatment prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the tumour is technically unresectable.
The new dosage regimen is:
- Docetaxel: 75 mg / m2 on day 1
- Cisplatin: 100 mg / m2 on day 1
- Fluorouracil 1000 mg / m2 / day on days 1 to 4 (continuous infusion)
Treatment is continued for three 21 day cycles.
There should be no objection to approval of the submission from Roche Products Pty Ltd to register AVASTIN solution for injection containing bevacizumab 25 mg/mL for the new indication:
AVASTIN (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for first-line treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous, non-small cell lung cancer.
There should be no objection to approval of the submission from CSL Limited to register BIOSTATE powder for injection containing Human Coagulation Factor VIII (250 IU or 500 IU per vial) and Human von Willebrand Factor (500 IU or 1000 IU per vial) for the new indication:
The treatment of bleeding episodes including surgical bleeding in patients with von Willebrand's disease when desmopressin treatment is ineffective or contraindicated.
21 August 2008