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ADEC 257th meeting resolutions, 4 April 2008

Australian Drug Evaluation Committee

4 April 2008

Published in the Commonwealth of Australia Gazette, No. GN 17, 30 April 2008

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 257th (2008/2) meeting of the Australian Drug Evaluation Committee (ADEC)(4 April 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 9166

There should be no objection to approval of the submission from Pfizer Australia Pty Ltd to register ERAXIS Powder for Injection containing the new chemical entity anidulafungin 100 mg for the indication:

The treatment of invasive candidiasis, including candidaemia.

RESOLUTION 9167

There should be no objection to approval of the submission from Novartis Pharmaceuticals Pty Ltd to register ACLASTA / OSTEOVAN Solution for Injection containing zoledronic acid 5mg/100mL for the new indications:

  • For the treatment of osteoporosis in patients aged over 50 years of age with a history of at least one low trauma hip fracture, to reduce the incidence of further fractures. Treatment should be restricted to no more than 3 annual doses.
  • Treatment of osteoporosis in postmenopausal women, to reduce the incidence of hip, vertebral and non-vertebral fractures. Treatment should be restricted to no more than 3 annual doses.

RESOLUTION 9168

There should be no objection to approval of the submission from GlaxoSmithKline Australia Pty Ltd to register PANDEMRIX Suspension for Injection containing the new biological entity influenza virus haemagglutinin [H5N1] for the indication:

Prophylaxis of influenza in an officially declared pandemic situation. PANDEMRIX should be used in accordance with official recommendations.

RESOLUTION 9169

There should be no objection to approval of the submission from Bristol-Myers Squibb Australia Pty Ltd to register ABILIFY INJECTION solution for injection, containing aripiprazole 7.5 mg/mL for the new indication:

The treatment of agitation associated with schizophrenia.

RESOLUTION 9170

There should be no objection to approval of the submission from Abbott Australasia Pty Ltd to register HUMIRA solution for injection containing adalimumab 40 mg/0.8mL for the indication:

The treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy

RESOLUTION 9171

There should be no objection to approval of the submission from Novartis Pharmaceuticals Pty Ltd to register ENVIAGE / RASILEZ tablets containing the new chemical entity aliskiren 150mg & 300mg for the indication:

Treatment of hypertension

RESOLUTION 9172

There should be no objection to approval of the submission from Dentsply (Australia) Pty Ltd to register ORAQIX fixed combination gel containing lignocaine 2.5% and prilocaine 2.5% for the indication:

For use in adults for localised anaesthesia in periodontal pockets for probing, scaling and/or root planning.

RESOLUTION 9173

There should be no objection to approval of the submission from Merck Sharp & Dohme (Australia) Pty Ltd to register the new fixed combinations FOSAMAX PLUS 70mg/140µg containing alendronate sodium 70 mg and cholecalciferol 140µg (5600 IU vitamin D3) for the indication:

The treatment of osteoporosis* in select patients where Vitamin D supplementation is recommended.

*Prior to treatment, osteoporosis must be confirmed by:

  • the finding of low bone mass of at least 2 standard deviations below the gender specific mean for young adults or by
  • the presence of osteoporotic fracture

RESOLUTION 9174

There should be no objection to approval of the submission from CSL Limited (Australia) to register PANVAX® VACCINE, suspension for injection, containing the new biological entity influenza virus haemagglutinin [H5N1], for the indication:

For the prevention of influenza caused by a pandemic strain of influenza virus.

21 April 2008