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ADEC 252nd meeting resolutions, 1 June 2007

Australian Drug Evaluation Committee

1 June 2007

Published in the Commonwealth of Australia Gazette, No. GN 27, 11 July 2007

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 252nd (2007/3) meeting of the Australian Drug Evaluation Committee (ADEC) (1 June 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 9067

There should be no objection to approval of the submission from Pfizer Australia Pty Ltd to register ARICEPT/ ARICEPT-D tablets containing donepezil hydrochloride 5mg and 10mg for the new indication:

The treatment of mild, moderate and severe Alzheimer's disease

RESOLUTION 9068

There should be no objection to approval of the submission from Novo Nordisk Pharmaceuticals Pty Ltd to register NOVOSEVEN powder for injection containing eptacog alfa 1.2mg, 2.4mg and 4.8mg for the new indications:

  • For the control of bleeding and surgery prophylaxis in patients with Glanzmann's thrombasthenia, who have antibodies to GPIIb-IIIa and/or HLA, and who have past or present refractoriness to platelet transfusions
  • For the control of bleeding and surgery prophylaxis in patients with congenital factor VII deficiency

RESOLUTION 9069

There should be no objection to approval of the submission from Merck Sharp & Dohme (Australia) Pty Ltd to register EMEND IV powder for injection containing the new chemical entity fosaprepitant dimeglumine 188mg for the indication:

For the prevention and treatment of chemotherapy-induced nausea and vomiting (CINV)

RESOLUTION 9070

There should be no objection to approval of the submission from Baxter Healthcare Pty Ltd to register OLICLINOMEL emulsion for injection containing amino acids, glucose and lipids, with or without electrolytes, for the indication:

Parenteral nutrition for adults and children above two years of age when oral or enteral nutrition is impossible, insufficient or contraindicated

RESOLUTION 9073

There should be no objection to approval of the submission from GlaxoSmithKline Australia Pty Ltd to register TYKERB tablets 250mg containing the new chemical entity lapatinib ditosylate 250mg for the indication:

In combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumours over express HER-2 /ErbB2) and whose tumours have progressed after treatment with an anthracycline, a taxane and trastuzumab.

RESOLUTION 9074

There should be no objection to approval of the submission from Schering-Plough Pty Limited to register NASONEX aqueous nasal spray containing mometasone furoate 50 µg per actuation for the new indication:

The treatment of acute rhinosinusitis in patients aged 12 and over, without signs of severe bacterial infection.

RESOLUTION 9075

There should be no objection to approval of the submission from Ferring Pharmaceuticals Pty Limited to register the new dose form [MINIRIN MELT] wafers containing desmopressin 60 µg, 120 µg and 240 µg for the following indications:

  • Cranial diabetes insipidus
  • Primary nocturnal enuresis in patients from 6 years of age with normal ability to concentrate urine, who are refractory to an enuresis alarm or in whom the enuresis alarm is contraindicated or inappropriate