You are here

TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

ADEC 247th meeting resolutions, 4 August 2006

Australian Drug Evaluation Committee

4 August 2006

Published in the Commonwealth of Australia Gazette, No. GN 34, 30 August 2006

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 247th (2006/4) meeting of the Australian Drug Evaluation Committee (ADEC) (4 August 2006) 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 8985

There should be no objection to approval of the submission from Biogen Idec Australia Pty Ltd to register TYSABRI injection containing the new biological entity natalizumab 300mg/15mL for the indication:

as monotherapy for the treatment of patients with relapsing remitting multiple sclerosis to delay the progression of physical disability and to reduce the frequency of relapse. The safety and efficacy of TYSABRI beyond two years are unknown.

RESOLUTION NO 8986

There should be no objection to approval of the submission from Ebos Group Pty Ltd to register ALUSTAL DERMATOPHAGOIDES PTERONYSSINUS; ALUSTAL D. FARINAE & ALUSTAL D. PTERONYSSINUS/ D. FARINAE Injections containing the new chemical entity House Dust Mite (European & American) for the indication:

treatment of patients with Type 1 allergy (Gell and Coombs classification), particularly presenting as seasonal or perennial rhinitis, conjunctivitis, rhinoconjunctivitis with or without associated asthma.

Top of page

RESOLUTION NO 8987

There should be no objection to approval of the submission from Ebos Group Pty Ltd to register ALUSTAL WHEAT/ ENGLISH PLANTAIN/ BERMUDA/ RYE/ OLIVE TREE/ THREE GRASSES/ FIVE GRASSES / TWELVE GRASSES Injections containing the new chemical entity Pollens and Grasses for the indication:

the treatment of patients with Type 1 allergy (Gell and Coombs classification), particularly presenting as seasonal or perennial rhinitis, conjunctivitis, rhinoconjunctivitis with or without associated asthma

RESOLUTION NO 8988

There should be no objection to approval of the submission from Pfizer Australia Pty Ltd to register ZELDOX capsules containing ziprasidone 20mg, 40mg, 60mg and 80mg for the new indication

As monotherapy for the short term treatment of acute manic or mixed episodes associated with bipolar 1 disorder.

RESOLUTION NO 8989

There should be no objection to approval of the submission from Schering Pty Limited to register VASOVIST injection containing the new chemical entity gadofosveset trisodium 244mg/mL for the indication

for contrast-enhanced magnetic resonance angiography for visualization of abdominal or limb vessels in patients with suspected or known vascular disease.

RESOLUTION NO 8990

There should be no objection to the approval of the submission from Servier Laboratories (Australia) Pty Ltd to register CORALAN tablets containing the new chemical entity ivabradine 5mg and 7.5mg for indications:

treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm who are unable to tolerate or who have a contraindication to the use of beta blockers.

RESOLUTION NO 8991

There should be no objection to the approval of the submission from Ipsen Pty Ltd to register the new dosage regimen of every 42 to 56 days for SOMATULINE AUTOGEL injection containing lanreotide acetate 120mg/0.5mL for the acromegaly indication.

RESOLUTION NO 8992

There should be no objection to the approval of the submission from Bayer Australia Limited to register NEXAVAR tablets containing the new chemical entity sorafenib tosylate 200mg for the indication

the treatment of advanced renal cell carcinoma

RESOLUTION NO 8993

  1. There should be no objection to the approval of the submission from Pfizer Australia Pty Ltd to register SUTENT capsules containing the new chemical entity Sunitinib 12.5mg, 25mg and 50mg for the indications
    • the treatment of gastrointestinal stromal tumour (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance
    • the treatment of advanced renal cell carcinoma (RCC)
  2. The Dosage and Administration should be 50 mg taken once daily. This should be on a schedule of 4 consecutive weeks of treatment followed by 2 weeks off (Schedule 4/2) to comprise a complete cycle of 6 weeks.