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ADEC 219th meeting resolutions, 6-7 December 2001

Australian Drug Evaluation Committee

6 December 2001

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 219th (2001/6) meeting of the Australian Drug Evaluation Committee (ADEC) (6-7 December 2001) resolved to advise the Parliamentary Secretary to the Minister for Health and Aged Care and the Secretary, Department of Health and Aged Care 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.

Somatropin Humatrope
Sterile powder for injection, containing somatropin 4 IU and16 IU in vials and 18 IU, 36 IU and 72 IU in cartridges
Eli Lilly Australia Pty Ltd
Variation: An alternative dosage regimen in children with growth hormone (GH) deficiency.

Rofecoxib Vioxx
Tablets, 12.5 mg and 25 mg, oral suspension, 12.5 mg/5 mL and 25 mg/5 mL
Merck Sharp & Dohme (Australia) Pty Ltd
Variation: Extension of indications to include the symptomatic treatment of rheumatoid arthritis.

Carvedilol Dilatrend
Tablets, 3.125 mg, 6.25 mg, 12.5 mg and 25 mg
Roche Products Pty Limited
Variation: Extension of indications to include the treatment of patients with symptomatic mild to severe (NYHA Class II to IV) congestive heart failure (CHF) as an adjunct to conventional treatments (eg iuretics, ACE inhibitors and vasodilators).

Sirolimus Rapamune
Oral solution, containing the new chemical entity sirolimus, 1mg per mL
Wyeth Australia Pty Ltd
Indication: Indicated for the prophylaxis of organ rejection in patients at mild to moderate immunological risk receiving renal transplants. Rapamume should be used initially in a regimen with cyclosporin microemulsion and corticosteroids. Cyclosporin withdrawal should be considered 2 to 4 months after transplantation.

Eflornithine Vaniqa
Cream, containing the new chemical entity eflornithine hydrochloride 13.9% w/v
Bristol-Myers Squibb Australia Pty Ltd
Indication: Indicated for the delay of regrowth of unwanted facial hair, following depilation, in women.

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Insulin NovoRapid
Sterile subcutaneous insulin infusion, 100 IU/mL
Novo Nordisk Pharmaceuticals Pty Ltd
Variation: Amendment of dosage and administration to include use for continuous subcutaneous insulin infusion (CSII) in pump systems suitable for insulin infusions.

Travoprost Travatan
Eye drops, and aqueous solution containing travoprost 0.004% w/v x 2.5 mL
Alcon Laboratories (Australia) Pty Ltd
Indication: Indicated to decrease elevated intraocular pressure in:

  • ocular hypertension
  • open-angle glaucoma

Travatan may be used:

  • as a first line therapy or monotherapy
  • as adjunctive therapy to timolol

Tegaserod Zelmac
Tablets, containing tegaserod maleate 6 mg
Novartis Pharmaceuticals Australia Pty Ltd
Indication: Indicated for the treatment of constipation predominant irritable bowel syndrome (C-IBS) in female patients whose main symptoms are constipation and abdominal pain and/or discomfort. The maximum duration of treatment should not exceed 12 weeks and treatment should be discontinued if there has been no response after 4 weeks.

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Paroxetine Aropax
Tablets, 20 mg and 30 mg and oral suspension 2 mg/mL
SmithKline Beecham Australia Pty Ltd
Variation: Extension of indications to include treatment of generalised anxiety disorder.

Topiramate Topamax
Tablets, 25 mg, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg and sprinkle capsules, 15 mg, 25 mg and 50 mg
Janssen-Cilag Pty Ltd
Variation: Extension the indications to include the following:

  • for monotherapy in patients with newly diagnosed epilepsy; and
  • for conversion to monotherapy in patients with epilepsy

in children from 2 years of age.

Peginterferon alfa-2b Pegatron
Sterile powder for injection, of 50 mg, 80 mg, 100 mg and 150 mg in vials, ribavirin capsules, 200 mg
Schering-Plough Pty Limited
Variation: New combination indicated for the following:

  • "For the treatment of chronic hepatitis C (see 'Clinical Trials'). Patients must be 18 years of age or older, not previously treated (naive patients) with interferon and with compensated liver disease.
  • Interferon alpha monotherapy (including PEG-Intron) is indicated mainly in case of intolerance or contraindication to ribavirin. Rebetrol Capsules must not be used alone because ribavirin is not effective as monotherapy in the treatment of hepatitis C.

Moxifloxacin Avelox IV
Sterile intravenous solution for injection, 400 mg/250 mL
Bayer Australia Limited
Variation: New dosage form and route of administration indicated for the treatment of patients who require initial intravenous therapy for the following indications:
Treatment of community acquired pneumonia and treatment of acute exacerbation of chronic bronchitis in patients who require initial intravenous therapy. Moxifloxacin is indicated in acute exacerbation of chronic bronchitis only when caused by organisms bacteriologically proven to be resistant to other classes of antibiotics or when there is intolerance to other antibiotics.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

4 January 2002

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