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ADEC 209th meeting resolutions, 6-7 April 2000

Australian Drug Evaluation Committee

6 April 2000

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 209th (2000/2) meeting of the Australian Drug Evaluation Committee (ADEC) (6-7 April 2000) 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.

OXIS TURBUHALER Eformoterol fumarate dihydrate
Powder for metered dose inhalation, 6 mg and 12 mg/actuation
Astra Pharmaceuticals Pty Ltd
Variation: To extend the indications to include on demand use in asthmatics over 18 years of age with suboptimal control despite treatment with inhaled corticosteroids, taken in combination with regular twice daily dosing of inhaled eformoterol.

MIRENA Levonorgestrel
Intrauterine device containing levonorgestrel 52 mg, releasing 20 mg/day
Schering Pty Limited
Indication: For use in contraception, idiopathic menorrhagia, and for protection from endometrial hyperplasia during oestrogen-replacement therapy.

DEHYDRATED ALCOHOL BP Ethanol
Solution for injection, 100% ethanol in 20 mL vials
FH Faulding & Co Limited
Indication: For use as an adjunct in the treatment of acute methanol and ethylene-glycol poisoning.

FIBRO-VEIN Sodium tetradecyl sulfate
Solution for injection, 0.2% (5 mL vials), 0.5% (2 mL ampoules) and 1.0% (2 mL ampoules)
Australasian Medical & Scientific Limited
Variation: New strengths for use in the treatment of uncomplicated varicose veins of the leg by compression sclerotherapy.

OGEN Piperazine oestrone sulfate
Tablets 0.625 mg, 1.23 mg and 2.5 mg
Pharmacia & Upjohn Pty Limited
Variation: To extend the indications to include the prevention of bone mineral density loss in postmenopausal women at risk of osteoporosis.

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EVISTA Raloxifene hydrochloride
Tablets, 60 mg
Eli Lilly Australia Pty Limited
Variation: To extend the indications to include the prevention and treatment of osteoporosis in postmenopausal women.

RHINOCORT Budesonide
Aqueous nasal spray, 32 mg and 64 mg/actuation
Astra Pharmaceuticals Pty Ltd
Variation: New strengths and dosage schedule. For the prevention and treatment of seasonal allergic rhinitis in adults and children and for the treatment of perennial allergic rhinitis and nasal polyps in adults.

INTRAGAM P Immunoglobulin, normal
Solution for injection, 6% w/v in 10, 50, 200 and 500 mL vials
CSL Limited
Variation: To extend the indications to include immunomodulatory therapy in idiopathic thrombocytopenic purpura (ITP), in adults and children at high risk of bleeding or prior to surgery to correct the platelet count, allogeneic haemopoietic stem cell transplantation and Kawasaki disease.

QVAR Beclomethasone dipropionate
Metered dose inhalers, 50 mg and 100 mg per actuation
3M Australia Pty Limited
Variation: To extend the approved patient population to include children aged 5 years and older, for the prophylactic management of asthma.

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FLIXOTIDE NEBULES Fluticasone propionate
Nebules, 0.5 mg/2 mL and 2 mg/2 mL
Glaxo Wellcome Australia Ltd
Variation: To extend the indications to include the treatment of mild to moderate acute exacerbations of asthma in children and adolescents aged 4 to 16 years in an outpatient setting.

ACTONEL Risedronate sodium
Tablets, equivalent to 5 mg and 30 mg risendronate
Aventis Pharma Pty Limited
Indication: For the treatment of postmenopausal osteoporosis, glucocorticoid-induced osteoporosis and Paget's disease of bone and for the preservation of bone mineral density in patients on long-term corticosteroid therapy.

AMPHOCIL Amphotericin B cholesteryl sulfate complex
Powder for reconstitution for IV Infusion, 50 mg and 100 mg
FH Faulding & Co Limited
Indication: For the treatment of invasive fungal disease caused by organisms susceptible to amphotericin B in adults and children 12 years or older in cases where toxicity or renal failure preclude the use of conventional amphotericin B in effective doses (see Clinical Trials).

AUGMENTIN DUO Amoxycillin trihydrate/clavulanic acid
Tablets, amoxycillin trihydrate 500 mg and clavulanic acid 125 mg
Smithkline Beecham (Australia) Pty Ltd
Variation: New dosage form for use as a twice daily regimen for the same indications as the currently registered Augmentin (250 mg/125 mg) tablets.

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VIRAMUNE Nevirapine hydrochloride
Oral suspension, 50 mg/5 mL
Boehringer Ingelheim Pty Limited
Variation: New dosage form for use in combination with antiretroviral agents for the treatment of HIV-1 infection in adults and children over the age of two months.

EXELON Rivastigmine hydrogen tartrate
Capsules, 0.5 mg, 1 mg, 1.5 mg, 3 mg, 4.5 mg and 6 mg
Novartis Pharmaceuticals Australia Pty Ltd
Indication: For the treatment of patients with mild to moderately severe dementia of the Alzheimer's type.

OPTIMARK Gadoversetamide
Solution for injection, 330 mg/mL
Mallinckrodt Australia Pty Ltd
Indication: For use as a contrast agent to enhance signal intensity in magnetic resonance imaging of intracranial and spinal lesions with an abnormal blood brain barrier or abnormal vascularity, and in whole body imaging.

ENBREL Etanercept
Powder for reconstitution for subcutaneous injection, 10 mg and 25 mg
Wyeth Australia Pty Limited
Indication: For the treatment of active rheumatoid arthritis in patients who have had an inadequate response to one or more disease modifying antirheumatic drugs.

REMICADE Infliximab
Powder for injection, 100 mg per vial
Schering-Plough Pty Ltd
Indication: For the treatment of moderate to severe Crohn's disease in patients who have had an inadequate response to conventional therapies and for draining enterocutaneous fistulae in patients with Crohn's disease.

BIOSTATE Factor VIII
Freeze-dried powder for reconstitution for intravenous injection, 250 IU/vial
CSL Limited
Indication: For the treatment and prophylaxis of bleeding associated with factor VIII deficiency due to haemophilia A.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

April 2000

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