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ADEC 256th meeting resolutions, 1 February 2008

Australian Drug Evaluation Committee

1 February 2008

Published in the Commonwealth of Australia Gazette, No. GN 9, 5 March 2008

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 256th (2008/1) meeting of the Australian Drug Evaluation Committee (ADEC) (1 February 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.

RESOLUTION 9147

There should be no objection to approval of the submission from Merck Sharp & Dohme (Australia) Pty Ltd to vary the Product Information for ARCOXIA film coated tablets containing Etoricoxib 30, 60 & 120mg by:

  • Adding a new starting dose of 30 mg for the symptomatic treatment of the signs and symptoms of osteoarthritis (OA). The recommended dose should be 30 mg daily and increased to 60 mg daily only if needed due to insufficient efficacy and after consideration of cardiovascular risk factors. A clinical review of medication should be conducted if there is no response within 4 weeks.
  • Including the data from two additional studies to further define the interaction between etoricoxib and the oral contraceptive pill (OCP) and with hormone replacement therapy (HRT) containing conjugated oestrogens.

RESOLUTION 9149

There should be no objection to approval of the submission from Wyeth Australia Pty Limited to register TORISEL Injection Solution containing the new chemical entity temsirolimus 25 mg/mL for the indication:

The treatment of advanced renal cell carcinoma.

RESOLUTION 9150

There should be no objection to approval of the submission from Novartis Pharmaceuticals Pty Ltd to register a new formulation and new route of administration for EXELON / PROMETAX Transdermal Drug Delivery Systems containing rivastigmine 9mg (Patch 5, surface area 5 cm2, 4.6 mg/24 hour release), 18mg (Patch 10, surface area 10 cm2, 9.5 mg/24 hour release), for the treatment of patients with mild to moderately severe dementia of the Alzheimer's type.

RESOLUTION 9152

There should be no objection to approval of the submission from Pfizer Australia Pty Ltd to register CELEBREX capsule containing celecoxib 100mg and 200mg for the new indication:

Symptomatic treatment of ankylosing spondylitis.

RESOLUTION 9153

There should be no objection to approval of the submission from Genzyme Australasia Pty Ltd to register MYOZYME Powder for Injection containing the new biological entity alglucosidase alfa (rch) 52.5 mg for the indication:

For the long-term treatment of patients with a confirmed diagnosis of Pompe disease (acid alfa-glucosidase deficiency).

RESOLUTION 9154

There should be no objection to approval of the submission from Pharmion Pty Ltd to register THALIDOMIDE PHARMION capsule containing thalidomide 50mg for the new indication:

Multiple Myeloma

  • Thalidomide Pharmion in combination with melphalan and prednisone is indicated for the treatment of patients with untreated multiple myeloma ≥ 65 years or ineligible for high dose chemotherapy.
  • Thalidomide Pharmion in combination with dexamethasone is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue, for the treatment of patients with untreated multiple myeloma.

RESOLUTION 9155

There should be no objection to approval of the submission from Novo Nordisk Pharmaceuticals Australia Pty Ltd to extend the patient population for LEVEMIR PENFILL / LEVEMIR FLEXPEN / LEVEMIR INNOLET Injection solution containing insulin detemir (rys) 100 U/mL for the new indication:

The treatment of Type 2 diabetes mellitus

There should be no objection to extend the patient population to include use in children aged 6-17 years for Type 1 diabetes mellitus.

RESOLUTION 9156

There should be no objection to approval of the submission from GlaxoSmithKline Australia Pty Ltd to vary the Product Information for AVANDIA tablet containing rosiglitazone (as maleate) 2 mg, 4 mg and 8 mg and AVANDAMET tablets containing rosiglitazone (as maleate)/metformin HCl 1 mg/500 mg, 2 mg/500 mg, 4 mg/500 mg, 2 mg/1000 mg and 4 mg/1000 mg to include safety data from the ADOPT study.

RESOLUTION 9157

There should be no objection to approval of the submission from Roche Products Pty Ltd to register new dosage regimens for the treatment of advanced or metastatic colorectal cancer for XELODA tablet containing capecitabine 150mg and 500mg for the indication:

  • the treatment of advanced or metastatic colorectal cancer (as monotherapy);
  • the adjuvant treatment of patients with Dukes' stage C, and high-risk stage B, colon cancer (as monotherapy);

The dosage regimen, in combination with oxaliplatin, with or without bevacizumab, is 1000 mg/m2 BD on days 1 - 14 of a 21 day cycle.

RESOLUTION 9158

There should be no objection to approval of the submission from Bayer Australia Limited to register NEXAVAR Tablet containing sorafenib (as tosylate) 200 mg for the new indication:

Treatment of patients with advanced hepatocellular carcinoma (HCC).