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ADEC 253rd meeting resolutions, 3 August 2007

Australian Drug Evaluation Committee

3 August 2007

Published in the Commonwealth of Australia Gazette, No. GN 35, 5 September 2007

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 253rd (2007/4) meeting of the Australian Drug Evaluation Committee (ADEC) (3 August 2007) 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 9082

There should be no objection to approval of the submission from GlaxoSmithKline Australia Pty Ltd to register a new dosage regimen for PRIORIX-TETRA injection containing, in each 0.5 mL dose, not less than 103.0 CCID50 (cell culture infective doses) of Schwarz measles virus, not less than 104.4 CCID50 of RIT 4385 strain of mumps virus, not less than 103.0 CCID50 of Wistar RA 27/3 rubella virus and not less than 103.3 PFU (plaque forming units) of Oka strain of varicella-zoster virus. PRIORIX-TETRA is indicated for active immunisation against measles, mumps, rubella and varicella from 9 months of age. Primary immunization could consist of one dose of vaccine. A second dose of vaccine may be given according to official recommendations.

RESOLUTION NO 9083

There should be no objection to approval of the submission from Octapharma Australia Pty Ltd to register WILATE powder for injection containing the new biological entity Human Coagulation Factor VIII and Von Willebrand Factor 450 IU / 400 IU per 5 mL for the indication:

  • Treatment and prophylaxis of bleeding including surgical bleeding in patients with haemophilia A (congenital factor VIII deficiency);
  • Treatment of bleeding episodes including surgical bleeding in patients with von Willebrand's disease when desmopressin treatment is ineffective or contraindicated.

RESOLUTION NO 9084

There should be no objection to approval of the submission from Orphan Australia Pty Ltd to register the new dose form DEPODUR modified release injection containing morphine sulfate 10mg/mL for the indication:

  • For the relief of post-operative pain following major orthopaedic, abdominal or pelvic surgery via the lumbar epidural route at a maximum recommended dose of 10mg. Appropriate monitoring must be maintained for at least 48 hours - see PRECAUTIONS.

RESOLUTION NO 9085

There should be no objection to approval of the submission from Pharmatel Fresenius Kabi Pty Ltd to register AMINOVEN 10% injection solution containing amino acids (10% w/v), electrolytes, glucose and triglycerides for the indication:

To supply amino acids as part of a composite admixture of total parenteral nutrition.

RESOLUTION NO 9086

There should be no objection to approval of the submission from Janssen-Cilag Pty Ltd to register INVEGA modified release tablets containing the new chemical entity paliperidone 3 mg, 6 mg, 9 mg, 12 mg for the indication:

The treatment of schizophrenia including acute treatment and recurrence prevention.

RESOLUTION NO 9089

The submission from Merck Sharp & Dohme (Australia) Pty Ltd to vary the Product Information for ARCOXIA, containing etoricoxib 60 mg and 120 mg tablets, by removing the current Black Box Warning at the beginning of the Product Information should be supported.

The other PI revisions, the addition of text in the Clinical Trials section to reflect the results of the MEDAL clinical study program, and the inclusion of data from an additional toxicology study in rabbits, which was conducted to examine further the potential effects of etoricoxib when administered during pregnancy, are also supported.

RESOLUTION NO 9090

There should be no objection to approval of the submission from Bristol-Myers Squibb Australia Pty Ltd to register ORENCIA lyophilised powder for injection containing the new biological entity abatacept 250mg for the indication:

Abatacept in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease modifying anti-rheumatic drugs (DMARDS), such as methotrexate or tumour necrosis factor (TNF) blocking agents. A reduction in the progression of joint damage and improvement in physical function have been demonstrated during combination treatment with abatacept and methotrexate.

Abatacept should not be administered concurrently with other biological DMARDs (eg TNF inhibitors, rituximab or anakinra).

RESOLUTION NO 9092

There should be no objection to approval of the submission from Octapharma Australia Pty Ltd to register PRONATIV powder for injection containing the new biological entity Human Prothrombin Complex 500IU for the indications:

Treatment of bleeding and perioperative prophylaxis in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in the case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required;

As second line therapy for the control of bleeding episodes and surgical prophylaxis in patients with congenital Factor VII deficiency, for whom recombinant human FVIIa has failed, is contraindicated or has been associated with unacceptable adverse effects.