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ADEC 234th meeting resolutions, 3-4 June 2004

Australian Drug Evaluation Committee

3 June 2004

Published in the Commowealth of Australia Gazette, No. GN 27, 7 July 2004

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 234th (2004/3) meeting of the Australian Drug Evaluation Committee (ADEC) (3-4 June 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.

AMOXYCILLIN (AS AMOXYCILLIN TRIHYDRATE & AMOXYCILLIN SODIUM)& CLAVULANIC ACID (AS POTASSIUM CLAVULANATE) 1000mg/62.5mg
Augmentin
Modified release Tablets
GlaxoSmithKline Australia Pty Ltd
New Dose Form & New strength: For the short term treatment of bacterial infections..... when caused by susceptible organisms in adults aged 16 years and above.

COMBINED DIPHTHERIA, TETANUS, ACELLULAR PERTUSSIS (DTPA) & INACTIVATED POLIOVIRUS VACCINE (IPV)
Boostrix®-IPV
Suspension for injection vials/prefilled syringe
GlaxoSmithKline Australia Pty Ltd
New Formulation: Booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis in individuals from the age of four years onwards.

CASPOFUNGIN (AS ACETATE) 50mg & 70mg
Cancidas
Powder for Injection vials
Merck Sharp & Dohme (Australia) Pty Limited
New Indication: Empirical therapy for presumed fungal infection in febrile, neutropenic, adult patients whose fever has failed to respond to broad-spectrum antibiotics.

ATORVASTATIN 10mg, 20mg, 40mg, and 80mg
Lipitor
Tablets
Pfizer Australia Pty Ltd
New Indication: Treatment in hypertensive patients with multiple risk factors and at high risk of coronary heart disease (CHD).

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IMIQUIMOD 50 mg/g
Aldara (5%)
Cream
3M Australia Pty Limited
New Indication: The primary treatment of confirmed superficial basal cell carcinoma where surgery is considered inappropriate.

HUMAN PROTEIN C (PLASMA DERIVED) 500IU &1,000IU
Ceprotin
Powder for Injection, vials
Baxter Healthcare Pty Ltd
New Chemical Entity: For the treatment of purpura fulminans and coumarin induced skin necrosis in patients with severe congenital protein C deficiency.

THYROTROPIN ALFA 1.1mg
Thyrogen
Powder for Injection, vials
New Indication: For use in conjunction with thyroglobin testing alone, for detection of thyroid remnants and well-differentiated thyroid cancer in post-thyroidectomy patients maintained on hormone suppression therapy.

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PEMETREXED DISODIUM 500mg
Alimta
Powder for Intravenous Infusion, vials
Eli Lilly Australia Pty Limited
New Chemical Entity: For the treatment of:

  • patients with malignant pleural mesothelioma, in combination with cisplatin
  • patients with locally advanced or metastatic non-small-cell lung cancer, after prior platinum-based therapy.

CLADRIBINE 10mg/mL
Litak
Solution for Injection, vials
Orphan Australia Pty Ltd
New Dose Form & New Strength: For the treatment of Hairy Cell Leukaemia (HCL) at a dose of 0.10 mg/kg/day by continuous IV infusion for 7 days, or by bolus SC administration at a dose of 0.14 mg /kg/day for 5 days; and second-line use in the treatment of lymphoplasmacytic lymphoma (Waldenstrom's macroglobulinaemia).

CALCIPOTRIOL AND BETAMETHASONE 50µg/g and 0.5mg/g
Daivobet
Ointment, tubes
CSL Limited
New Fixed Combination: For the once daily topical treatment of plaque-type psoriasis vulgaris amenable to topical therapy.

METFORMIN HCL/GLIBENCLAMIDE 250/1.25mg, 500/2.5mg and 500/5mg
Glucovance
Film Coated Tablets
Alphapharm Pty Limited
New Fixed Combination: For the second-line treatment of diabetes mellitus type II in Patients whose glycaemic control is inadequate after diet and exercise alone and where combined therapy with metformin and glibenclamide is appropriate.

ESOMEPRAZOLE 40mg
Nexium IV
Intravenous Injection Infusion, vials
AstraZeneca Pty Ltd
New Dose Form: For the short-term management of severe gastro-oesophagael reflux disease where oral therapy is inappropriate.

INFLIXIMAB 100mg
Remicade
Powder for Injection, vials
Schering-Plough Pty Limited
New Indication: For the treatment of refractory fistulising Crohn's disease.

23 June 2004

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