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ADEC 235th meeting resolutions, 12-13 August 2004

Australian Drug Evaluation Committee

12 August 2004

Published in the Commowealth of Australia Gazette, No. GN 35, 1 September 2004

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 235th (2004/4) meeting of the Australian Drug Evaluation Committee (ADEC) (12-13 August 2004) 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.

FONDAPARINUX 12.5mg/mL in 5mg/0.4mL, 7.5mg/0.6mL and 10mg/0.8mL
Arixtra
Pre-filled syringes
Sanofi-Synthelabo Australia Pty Limited
New Indication: For the treatment of acute deep venous thrombosis (DVT) and acute pulmonary embolism (PE).

MELOXICAM 7.5mg and 15mg
Mobic
Tablets and Capsules
Boehringer Ingelheim Pty Limited
New Indication: For the treatment of rheumatoid arthritis.

MOXONIDINE 0.2 mg, 0.3 mg and 0.4 mg
Physiotens, Normatens
Solvay Pharmaceuticals
Tablets
New Chemical Entity: For the treatment of hypertension.

PARACETAMOL 10mg/mL
Perfalgan
Solution for Infusion
Bristol-Myers Squibb Australia Pty Ltd
New Route of Administration & New Dose Form: For the relief of mild to moderate pain and the reduction of fever where an intravenous route of administration is considered clinically necessary.

PERINDOPRIL ERBUMINE 2mg, 4mg and 8mg
COVERSYL
Tablets
Servier Laboratories (Australia) Pty Ltd
New Dosage Regimen: Treatment of hypertension, with a reduced starting dose in the elderly, patients who are salt or volume depleted, patients with reno-vascular hypertension and patients with heart failure.

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BIVALIRUDIN 250mg and 100mg
Angiomax
Powder for Injection
CSL Limited
New Chemical Entity: For use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI).

LEVODOPA/CARBIDOPA/ENTACAPONE 50mg/12.5mg/200mg, 100mg/25mg/200mg, & 150mg/37.5mg/200mg
Stalevo
Film-Coated Tablet
Novartis Pharmaceuticals Australia Pty Ltd
New Fixed Dose Combination: For the management of patients with Parkinson's disease who are experiencing motor fluctuations.

ROPINIROLE (AS HYDROCHLORIDE) 0.25mg, 0.5mg, 1.0mg and 2.0mg
Repreve
Film Coated Tablet
GlaxoSmithKline Australia Pty Ltd
New Indication: For the treatment of primary restless legs syndrome, including the reduction of associated periodic limb movement and episodes of nocturnal arousal.

MESALAZINE 1.0g per application
Salofalk
Foam Enema
Orphan Australia Pty Ltd
New Dose Form: The treatment of acute ulcerative colitis of mild to moderate severity and for the maintenance treatment of ulcerative colitis.

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RISPERIDONE (0.25, 0.5, 1.0, 2.0, 3.0, 4.0 & 6.0) mg and 1mg/mL
Risperdal
Tablet & Oral solution
Janssen-Cilag Pty Ltd
New Indication: As monotherapy for the short term treatment of acute mania associated with bipolar 1 disorder.

LANSOPRAZOLE 15mg and 30mg
Zoton, Lanzo
Capsules and Granules (Zoton only)
Wyeth Australia Pty Ltd
New Indication: To include the treatment of gastro-oesophageal reflux disease including all grades of oesophagitis and healing of erosive oesophagitis in children and adolescents 1-17 years of age.

HUMAN NORMAL IMMUNOGLOBULIN 5%
Octagam
Solution in vials and bottles
Octapharma Australia Pty Limited
New Chemical Entity: Indicated for the following:

  • Replacement therapy
    • primary immunodeficiency syndromes;
    • congenital agammaglobulinaemia and hypogammaglobulinaemia
    • common variable immunodeficiency
    • severe combined immunodeficiencies
    • Wiskott Aldrich syndrome
  • Myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections
  • Children with congenital Acquired Immune Deficiency Syndrome (AIDS) who have repeated bacterial infections.
  • Immunomodulatory effect
    • Idiopathic Thrombocytopenic Purpura (ITP) in adults or children with a high risk of bleeding or prior to surgery to correct platelet count.
    • Guillain Barré syndrome
    • Kawasaki disease.
  • Allogeneic bone marrow transplantation.

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DACLIZUMAB 25mg/5mL
Zenapax
Concentrated Solution for Infusion
Roche Products Pty Limited
New Patient Population: For use in children.

EFALIZUMAB 125 mg
Raptiva
Powder for Injection, vials
Serono Australia Pty Ltd
New Chemical Entity: For the treatment of adult patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy. Safety and efficacy beyond 12 months have not been established.

ETONOGESTREL 11.7mg (releasing 120µg / 24 hours) & ETHINYLOESTRADIOL 2.7mg (releasing 15µg / 24 hours)
Nuvaring
Annular intravaginal releasing system
Organon (Australia) Pty Ltd
New Fixed Combination/New Route of Administration/New Dose Form: For use for contraception.

ROSIGLITAZONE AS MALEATE 2mg, 4mg and 8mg
Avandia
Tablets
GlaxoSmithKline Australia Pty Ltd
New Indication: To include in triple combination therapy with metformin and sulphonylureas to improve glycaemic control in patients with Type 2 diabetes mellitus.

ROSIGLITAZONE AS MALEATE AND METFORMIN HYDROCHLORIDE 1 mg /500 mg, 2 mg /500mg & 4 mg /500 mg
Avandamet
Fixed dose combination tablets
GlaxoSmithKline Australia Pty Ltd
New Formulation & New Combination: As an adjunct to diet and exercise to improve glycaemic control in patients with Type 2 diabetes mellitus who are already treated with rosiglitazone and metformin in combination, or who are inadequately treated on metformin or rosiglitazone alone.

ABACAVIR (AS SULFATE) 300mg
Ziagen
Tablet
GlaxoSmithKline Australia Pty Ltd
New Fixed Dose Combination: For use in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents > 12 years.

25 August 2004

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