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ADEC 221st meeting resolutions, 4-5 April 2002

Australian Drug Evaluation Committee

4 April 2002

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 221st (2002/2) meeting of the Australian Drug Evaluation Committee (ADEC) (4-5 April 2002) 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.

INSULIN LISPRO Humalog
Sterile continuous subcutaneous infusion pumps
Eli Lilly Australia Pty Ltd
Variation: For use in continuous subcutaneous infusion pumps.

PRAMIPEXOLE Sifrol
Tablets, 125 µg and 250 µg, 1 mg, 1.25 mg and 1.5 mg
Boehringer Ingelheim Pty Limited
Indication: Extension of indications to include for the treatment of signs and symptoms of idiopathic Parkinson's disease. It may be used as monotherapy or in combination with levodopa.

RILUZOLE Rilutek
Tablets, 50mg
Aventis Pharma Pty Limited
Indication: For the treatment of amyotrophic lateral sclerosis.

ERTAPENEM Invanz
Sterile powder for injection, 1 g vials
Merck Sharp & Dohme (Australia) Pty Ltd
Indication: Indicated for:

  • Treatment of adult patients with moderate to severe infections caused by susceptible strains of micro organisms which are suspected or proven to be resistant to all other antibiotics, or for patients unable to tolerate other antibiotics; and
  • For initial empiric therapy for the treatment of complicated intra-abdominal infections and acute pelvic infections including, postpartum endomyometritis, septic abortion and post-surgical gynecological infections.

OSELTAMVIR Tamiflu
Tablets, 75 mg
Roche Products Pty Ltd
Variation: Extension of indications to include for the prophylaxis of influenza in adults and adolescents aged 13 years and older. Vaccination is the preferred method of prophylaxis against infection with influenza viruses. Routine prophylaxis with oseltamivir is not recommended.

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VALGANCICLOVIR Valcyte
Film-coated tablets, 450 mg
Roche Products Pty Ltd
Indication: For the treatment of cytomegalovirus retinitis (CMV) in patients with AIDS.
(For induction and maintenance treatment of CMV retinitis).

TENOFOVIR Viread
Tablets, 300 mg
Gilead Sciences Pty Ltd
Indication: For use in combination with other antiretroviral agents, for the treatment of HIV infected adults. Evidence to support this indication is based on surrogate endpoints (change in viral load and CD4 count) (see "Clinical Trials").

INACTIVATED HEPATITIS A VACCINE Vaqta
Sterile solution for subcutaneous injection, 50 U/mL vials
Merck Sharp & Dohme (Australia) Pty Ltd
Variation: To amend the indications and dose regimen to include HIV infected adults; to include subcutaneous administration when clinically appropriate; and to include an extension of adult booster dose timing.

ENOXAPARIN Clexane
Sterile injection, 20 mg, 40 mg, 60 mg, 80 mg and 100 mg prefilled syringes
Aventis Pharma Pty Limited
Variation: Indicated to reduce the dosage regimen in patients with severe renal failure and to amend the Precautionary Statements section of the Clexane Product Information to include a statement that dose reduction may be required in older people because of age-related impairment of renal function and increased risk of haemorrhage.

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COMBINED DIPHTHERIA, TETANUS, ACELLULAR PERTUSSIS AND INACTIVATED POLIOMYELITIS VACCINE Infanrix-IPV
Sterile solution for injection, 0.5 ml dose
GlaxoSmithKline Australia Pty Ltd
Indication: For use in a three dose primary series for immunisation of infants from 6 weeks of age and over, against diphtheria, tetanus, pertussis and poliomyelitis.
Also recommended as a single booster dose for children from 15 months of age up to and including 6 years of age who have previously been immunised against diphtheria, tetanus, pertussis and poliomyelitis.

PARECOXIB SODIUM Dynastat
Sterile solution for intravenous or intramuscular injection, 20 mg and 40 mg vials
Pharmacia Australia Pty Limited
Variation: For use as a single peri-operative dose, for the management of post-operative pain.

DILTIAZEM HYDROCHLORIDE GenRx Diltiazem CD, Healthsense Diltiazem CD, Terry White Chemists Diltiazem CD and Chem mart Diltiazem CD
Modified-release capsules, 180 mg and 240 mg
Faulding Healthcare Pty Ltd
Indication: For the treatment of mild to moderate essential hypertension and management of chronic stable angina (effort associated angina) where there is no evidence of vasospastic or unstable angina. Because the safety and efficacy of CD capsules in the management of unstable or vasospastic angina has not been substantiated, use of this formulation for these indications is not recommended.

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AGALSIDASE ALPHA Replagal
Sterile concentrate for solution for intravenous infusion, 1.0 mg/mL
O'Shea and Associates
Indication: For long-term enzyme replacement therapy of patients with Fabry disease (±-galactosidase A deficiency).

PACLITAXEL Taxol
Sterile solution for intravenous infusion, 6 mg/mL vials
Bristol-Myers Squibb Pharmaceuticals Pty Ltd
Variation: To amend the recommended dosage regimen for the primary treatment of ovarian cancer in combination with a platinum agent. The approved regimens should be:

  • 175 mg/m2 infused intravenously over 3 hours, followed by cisplatin 75 mg/m2, with a three week interval between courses; or
  • 135 mg/m2 infused intravenously over 24 hours, followed by cisplatin 75 mg/m2, with a three week interval between courses.

OMALIZUMAB Xolair
Sterile powder for injection, 150 mg vials
Novartis Pharmaceuticals Australia Pty Ltd
Indication: For the management of adult and adolescent patients with moderate allergic asthma, who are already being treated with inhaled steroids, and who have raised serum immunoglobulin E levels.

CAPECITABINE Xeloda
Tablets, 150 mg and 500 mg
Roche Products Pty Limited
Variation: Extension of indications to include:

  1. In combination with docetaxel, for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.
  2. There should also be no objections to the application to revise the wording of the currently approved indication for breast cancer to:
    • the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen, unless therapy with these other standard agents is clinically contraindicated.

BICALUTAMIDE Cosudex
Tablets, 150 mg
AstraZeneca Pty Ltd
Variation: Indicated for the following:

  • In patients with localised prostate cancer as immediate therapy in patients who are not receiving treatment of curative intent.
  • In patients with locally advanced prostate cancer is indicated as adjuvant therapy to treatment of curative intent, or alone as immediate therapy in patients who are not receiving treatment of curative intent.

LEVONORGESTREL/ETHINYLOESTRADIOL Loette
Tablets, 100 µg and 20 µg
Wyeth Australia Pty Limited
Variation: Extension of indications to include the treatment of moderate acne vulgaris not controlled by topical measures in post-menarchal, pre-menopausal women who accept contraception.

FLUDARABINE Fludara
Tablets, 10 mg
Schering Pty Limited
Variation: For use as a second-line therapy in patients with chronic lymphocytic leukaemia.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

April 2002

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