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ADEC 212th meeting resolutions, 5-6 October 2000

Australian Drug Evaluation Committee

5 October 2000

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 212th (2000/5) meeting of the Australian Drug Evaluation Committee (ADEC) (5-6 October 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.

HUMATROPE Somatropin
Sterile powder for reconstitution for subcutaneous or intramuscular injection, 4 IU and 16 IU in vials; 18 IU, 36 IU and 72 IU in cartridges
Eli Lilly Australia Pty Ltd
Variation: Extension ofIndications to include treatment of growth retardation in pre-pubertal children with chronic renal insufficiency whose height is on or less than the twenty-fifth percentile and whose growth velocity is on or less than the twenty-fifth percentile for bone age.

ORGALUTRAN Ganirelix
Sterile solution for subcutaneous injection, 0.25 mg/0.5 mL in disposable pre-filled glass syringes
Organon (Australia) Pty Limited
Indication: For the prevention of premature luteinisation and ovulation in patients undergoing controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.

ACTOS Pioglitazone hydrochloride
Tablets, 15 mg, 30 mg and 45 mg
Eli Lilly Australia Pty Ltd
Indication: For the treatment of type 2 diabetes mellitus inadequately controlled by diet. ACTOS is effective as a single agent, and may also be used in combination with sulfonylureas, metformin or insulin when diet plus the single agent does not result in adequate glycaemic control.

FOSAMAX Alendronate sodium
Tablets, 5 mg
Merck Sharp & Dohme (Australia) Pty Limited
Variation: Extension ofIndications to include prevention of bone mineral density loss in post-menopausal women who are osteopenic (T score of -1 to -2.5).

NOVONORM Repaglinide
Tablets, 0.5 mg, 1 mg and 2 mg
Novo Nordisk Pharmaceuticals Pty Ltd
Variation: Extension ofIndications to include first-line use and combination therapy with insulin in people with type 2 diabetes who are not satisfactorily controlled on sulphonylureas or NovoNorm alone.

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DIPRIVAN Propofol
Sterile oil-in-water emulsion for intravenous injection, 1 mg/mL in 20 mL ampoules, 50 mL and 100 mL vials, 20 mL and 50 mL syringes
AstraZeneca Pty Ltd
Variation: A new formulation for the currently approvedIndications.

LUVOX Fluvoxamine maleate
Tablets, 50 mg and 100 mg
Solvay Pharmaceuticals
Variation: Extension of the patient population to include use in children and adolescents aged 8-17 years for the treatment of obsessive-compulsive disorder.

LAMICTAL Lamotrigine
Dispersible/chewable tablets, 5 mg, 25 mg, 50 mg, 100 mg and 200 mg, uncoated tablets, 25 mg, 50 mg, 100 mg and 200 mg
Glaxo Wellcome Australia Ltd
Variation: To alter the starting dose and dose escalation for paediatric patients and amend the product information.

BOTOX Botulinum toxin, type A
Sterile solution for intramuscular injection, 100 IU per vial
Allergen Australia Pty Ltd
Variation: Extension ofIndications to include treatment of cervical dystonia (spasmodic torticollis).

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SUBUTEX Buprenorphine
Sublingual tablets, 2 mg, 4 mg and 8 mg
Reckitt Benckiser (Australia) Pty Limited
Variation: A new dose form and new strengths for the treatment of opiate dependence within a framework of medical, social and psychological treatment.

AVELOX Moxifloxacin hydrochloride
Tablets, 400 mg
Bayer Australia Limited
Indication: For the treatment of adults with bacterial infections caused by susceptible organisms in the following conditions: acute bacterial sinusitis; community-acquired pneumonia (of mild to moderate severity); and acute exacerbation of chronic bronchitis.

TEQUIN Gatifloxacin
Tablets, 200 mg and 400 mg, sterile solution for intravenous injection, 200 mg/20 mL and 400 mg/40 mL in vials, sterile solution for intravenous infusion in Flexibags, 200 mg/100 mL and 400 mg/200 mL
Bristol-Myers Squibb Australia Pty Ltd
Indication: For the treatment of adults with the following infections caused by susceptible bacteria: acute bacterial sinusitis; community-acquired pneumonia; acute bacterial exacerbation of chronic bronchitis; uncomplicated urethral, pharyngeal, and rectal gonorrhoea in males, and endocervical, pharyngeal and rectal gonorrhoea in females.

RELENZA ROTADISK Zanamivir
Dry powder for oral inhalation, 5 mg per inhalation
Glaxo Wellcome Australia Ltd
Variation: Extension of the patient population to include use in children aged five years and older, and extension ofIndications to include prophylaxis of infection due to influenza A and B viruses in circumstances where prophylaxis of healthy young adults is justified.

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H-B VAX II Hepatitis B vaccine, recombinant
Sterile solution for intramuscular injection, 10 µg/mL
Merck Sharp & Dohme (Australia) Pty Limited
Variation: A new two-dose regimen for adolescents aged 11-15 years for immunisation against infection caused by all known subtypes of hepatitis B virus.

NEURONTIN Gabapentin
Tablets, 600 mg and 800mg, capsules, 100 mg, 300 mg and 400 mg
Parke Davis Pty Ltd
Variation: A new dose regimen and extension ofIndications to include the treatment of neuropathic pain.

METALYSE Tenecteplase
Sterile powder for reconstitution for intravenous injection, 6000 IU, 8000 IU and 10000 IU per vial
Boehringer Ingelheim Pty Limited
Indication: For the thrombolytic treatment of the acute phase of myocardial infarction.

TRITACE Ramipril
Tablets, 1.25 mg, 2.5 mg and 5 mg and capsules, 10 mg
Aventis Pharma Pty Limited
Variation: Extension of Indications to include use for: 1) for reducing the risk of myocardial infarction, stroke, cardiovascular death or need for revascularisation procedures in patients 55 years or more who have clinical evidence of coronary artery disease, stroke or peripheral vascular disease; and 2) for reducing the risk of myocardial infarction, stroke, cardiovascular death or need for revascularisation procedures in diabetic patients 55 years or more who have one or more of the following risk factors: systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg, total cholesterol >5.2 mmol/L, HDL cholesterol <0.9 mmol/L, current smoker, known microalbuminuria, or any evidence of previous vascular disease.

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REFACTO Moroctocog alpha (Factor VIII, recombinant [cho])
Sterile powder for reconstitution for intravenous injection, 250 IU, 500 IU and 1000 IU per vial
Wyeth Australia Pty Limited
Indication: For the control and prevention of haemorrhagic episodes in patients with haemophilia A, including control and prevention of bleeding in surgical settings.

COLAZIDE Balsalazide sodium
Capsules, 750 mg
Astra Pharmaceuticals Pty Ltd
Indication: For the treatment and maintenance of remission of acute mild to moderate ulcerative colitis in patients who are intolerant, sensitive or allergic to sulphasalazine.

ASMANEX TWISTHALER Mometasone furoate
Powder for inhalation, 200 µg and 400 µg per actuation
Schering-Plough Pty Ltd
Variation: A new dose form and new route of administration for the management of asthma in patients aged twelve years and older.

HELIXATE NEXGEN/KOGENATE FS Factor VIII, recombinant [bhk]
Sterile powder for reconstitution for intravenous injection, 250 IU, 500 IU and 1000 IU per vial
Bayer Australia Limited
Variation: A new formulation for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital Factor VIII deficiency).

GEMZAR Gemcitabine hydrochloride
Sterile powder for reconstitution for intravenous injection, 200 mg and 1 g per vial
Eli Lilly Australia Pty Limited
Variation: A new dosage regimen and extension ofIndications to include use in combination with cisplatin in the treatment of non-small cell lung cancer, and in the treatment of advanced bladder cancer, alone or in combination with cisplatin.

FLIXOTIDE JUNIOR CFC-FREE Fluticasone propionate
CFC-free metered dose inhaler, 50 µg per actuation
Glaxo Wellcome Australia Ltd
Variation: A new formulation, for the prophylactic management of asthma in adults and children aged one year and older.

GRANOCYTE Lenograstim
Sterile powder for reconstitution for injection, 13.4 million IU and 33.6 million IU per vial
AMRAD Pharmaceuticals Pty Ltd
Variation: Extension ofIndications to include mobilisation of peripheral blood progenitor cells in healthy donors.

XELODA Capecitabine
Tablets, 150 mg and 500 mg
Roche Products Pty Limited
Variation: Extension ofIndications to include treatment of patients with advanced or metastatic colorectal cancer.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

30 October 2000

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