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ADEC 207th meeting resolutions, 2-3 December 1999

Australian Drug Evaluation Committee

2 December 1999

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 207th (1999/7) meeting of the Australian Drug Evaluation Committee (ADEC) (2-3 December 1999) 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.

GONAL F Follitropin alfa (recombinant human follicle stimulating hormone)
Lyophilised powder in 75 IU and 150 IU ampoules
Serono Australia Pty Ltd
Variation: To include concomitant therapy with human chorionic gonadotrophin (hCG) for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective.

PROLEUKIN Aldesleukin (rbe) (recombinant human interleukin-2)
Powder for injection vial, 9 million and 18 million IU
CSL Limited
Indication: For the treatment of metastatic renal cell carcinoma via the subcutaneous route.

REBETRON COMBINATION THERAPY Interferon alfa-2b and ribavirin
Capsules, 200 mg; Interferon alfa-2b (Intron A) vials, 3 MIU/0.5 mL, 18 MIU/3 mL; and multi-dose pen (Redipen), 18 MIU/1.2 mL
Schering-Plough Pty Ltd
Variation: To extend the approved indications to include treatment of chronic hepatitis C in patients 18 years of age and older with compensated liver disease previously untreated with alfa interferon or who have relapsed following alfa interferon therapy (see clinical trials).

SOMAC Pantoprazole sodium
Freeze-dried powder for injection, 40 mg
Pharmacia & Upjohn Pty Limited
Variation: For short-term use when oral therapy is not appropriate. The indications should be identical to those approved for the oral formulations.

AVANDIA Rosiglitazone maleate
Tablets, 1 mg, 2 mg, 4 mg and 8 mg
SmithKline Beecham (Australia) Pty Ltd
Indication: For the treatment of type II diabetes mellitus (non-insulin dependent diabetes mellitus), as monotherapy in patients inadequately controlled by diet and exercise, and in combination with sulfonylureas or metformin to improve glycaemic control.

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TRITACE Ramipril
Tablets, 1.25 mg, 2.5 mg and 5.0 mg
Hoechst Marion Roussel Australia Pty Ltd
Variation: To extend the indications to include the prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 G/day.

RENITEC PLUS Enalapril maleate and hydrochlorothiazide
Tablet, 20 mg/6 mg
Merck Sharp & Dohme (Australia) Pty Limited
Variation: For the treatment of mild to moderate hypertension. Treatment should not be initiated with this fixed-dose combination.

TOBI Tobramycin
Solution for inhalation, 60 mg/mL, 5 mL ampoules
La Rosa Langley Pty Ltd (on behalf of PathoGenesis Corporation, USA)
Variation: For the management of cystic fibrosis patients with Pseudomonas aeruginosa infection (see clinical trials section).

ZOLADEX Goserelin acetate
Implant, 3.6 mg
AstraZeneca
Variation: To amend the product information to include a statement regarding the addition of hormone replacement therapy in patients receiving Zoladex for the treatment of endometriosis.

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NOVORAPID Insulin aspart
Solution for subcutaneous injection, 100 IU/mL in 10 mL vials; Penfill cartridges, 1.5 mL and 3 mL; NovoLet prefilled syringes, 1.5 mL and 3 mL
Novo Nordisk Pharmaceuticals Pty Ltd
Indication: For the treatment of diabetes mellitus.

VARIVAX Live attentuated varicella virus vaccine
A single dose of reconstituted vaccine contains a minimum of 1350 Plaque Forming Units of live attentuated varicella vaccine Oka/Merck strain in 0.5 mL
Merck Sharp & Dohme (Australia) Pty Limited
Indication: For active immunisation against varicella in individuals 12 months of age and older.

ZIDOVAL Metronidazole Vaginal Gel 0.75 %
Gel, 37.5 mg/5 g, in 40 g tube with 5 disposable applicators
3M Pharmaceuticals Pty Ltd
Indication: For the treatment of symptomatic bacterial vaginosis (as defined in the dosage and administration section).

SERETIDE Salmeterol xinafoate and fluticasone propionate
Dry powder for inhalation, 50 µg/100 µg, 50 µg/250 µg and 50 µg/500 µg per actuation
Glaxo Wellcome Australia Ltd
Indication: For the regular treatment of asthma, where the use of a combination product is appropriate.

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KONAKION MM PAEDIATRIC Phytomenadione
Injection and oral solution, 2 mg/0.2 mL ampoule
Roche Products Pty Limited
Indication: For the prophylaxis of haemorrhagic disease of the newborn by intramuscular or oral administration.

MS MONO Morphine sulfate
Controlled release capsules, 30 mg, 60 mg, 90 mg, 120 mg, 150 mg and 200 mg in blisters and bottles
Mundipharma Pty Limited
Indication: For the treatment of opioid-responsive, chronic severe pain.

NEURONTIN Gabapentin
Capsules, 100 mg, 300 mg and 400 mg
Parke Davis Pty Ltd
Variation: To extend the approved indications to include use in paediatric patients for the treatment of partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children more than 3 years of age who have not achieved adequate control with standard anti-epileptic drugs.

IMOGAM RABIES Rabies human immune globulin
Injection, human rabies immunoglobulin, 300 IU/2 mL and 1500 IU/10 mL vials.
CSL Limited
Indication: For use in subjects thought to be exposed to the rabies virus, in accordance with World Health Organisation guidelines.

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COMVAX Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (recombinant) vaccine
Single dose vial, 0.5 mL, containing 7.5 µg Haemophilus b PRP, 125 µg of Neisseria meningitis OMPC and 5 µg of HBsAg
Merck Sharp & Dohme (Australia) Pty Limited
Indication: For vaccination against invasive disease caused by Haemophilus influenzae type B and against infection caused by all known serotypes of hepatitis B, in infants six weeks to 15 months of age born of HBsAg-negative mothers.

LIVIAL Tibolone
Tablets, 2.5 mg
Organon (Australia) Pty Limited
Indication: For the treatment of symptoms resulting from the natural or surgical menopause and for the prevention of post-menopausal bone mineral density loss.

ETHYOL Amifostine
Powder for injection, 500 mg/10 mL vial
Schering-Plough Pty Ltd
Variation: To extend the approved indications to include protection against acute and late xerostomia associated with standard fractionated radiation therapy in patients with head and neck cancer.

REFLUDAN Lepirudin
Powder for injection, 50 mg/2 mL vial
Hoechst Marion Roussel Australia Pty Ltd
Indication: For the treatment of acute heparin-associated thrombocytopenia (HAT) type II patients with thrombocytopenia or thromboembolic complications.

The ADEC also varied the following recommendation for approval (see Commonwealth of Australia Gazette No GN 44, 3 November 1999, page 3881):

KARVEZIDE/AVAPRO HCT Irbesartan/hydrochlorothiazide
Tablets, 150 mg/12.5 mg and 300 mg/12.5 mg
Sanofi-Synthelabo Australia Pty Limited/Bristol-Myers Squibb Australia Pty Ltd
Indication: For the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

December 1999

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