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ADEC 241st meeting resolutions, 4-5 August 2005

Australian Drug Evaluation Committee

4 August 2005

Published in the Commowealth of Australia Gazette, No. GN 35, 7 September 2005

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 241st (2005/4) meeting of the Australian Drug Evaluation Committee (ADEC) (4-5 August 2005) 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.

PALIFERMIN 6.25mg
Kepivance
Powder for Injection
Amgen Australia Pty Ltd.
New Chemical Entity: To decrease oral mucositis in patients with haematological malignancies receiving myelotoxic therapy requiring haematopoietic stem cell support.

CAPECITABINE 150mg and 500mg
Xeloda
Tablet
Roche Products Pty Ltd.
New Indication: To include the adjuvant treatment of Dukes' stage C and high-risk stage B colon cancer.

APREPITANT 80mg and 125mg
Emend
Capsule
Merck Sharp & Dohme Pty Ltd.
New Indication: For the treatment of nausea and vomiting in patients receiving moderately emetogenic chemotherapy.

TESTOSTERONE UNDECANOATE 1000mg per 4mL
Nebido
Solution for Injection
Schering Pty Ltd.
New Dose Form: For testosterone replacement in primary and secondary male hypogonadism.

IMIQUIMOD 5%
Aldara
Cream
3M Pharmaceuticals Pty Ltd.
New Indication: For the treatment of actinic keratitis (AK) of the face and scalp.

RASAGILINE MESYLATE 1 mg
Azilect
Tablet
Lundbeck Australia Pty Ltd.
New Chemical Entity: For the symptomatic treatment of idiopathic Parkinson's disease as monotherapy (without concomitant levodopa/decarboyxlase inhibitor therapy) or as adjunct therapy (with concomitant levodopa/decarboxylase inhibitor therapy).

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ESCITALOPRAM OXALATE 5mg, 10mg, 15mg, 20mg and 10mg/mL
Lexapro
Tablet and Oral Solution
Lundbeck Australia Pty Ltd.
New Indication: For the treatment of Social Anxiety Disorder (Social Phobia), and for the treatment of Generalised Anxiety Disorder in adults.

MESALAZINE 1g/100mL
Pentasa
Enema
Ferring Pharmaceuticals Pty Limited
New Indication: For the treatment of left-sided ulcerative colitis.

TENOFOVIR DISOPROXIL FUMARATE / EMTRICITABINE 300mg / 200mg
Truvada
Tablet
Gilead Sciences Pty Ltd.
New Combination: For the treatment of HIV infected adults over the age of 18 years, in combination with other antiretroviral agents.

PEGINTERFERON ALFA-2a 180µg/0.5mL
Pegasys
Solution for Injection
Roche Products Pty Ltd.
New Indication: For the treatment of:

  • chronic hepatitis B in patients with evidence of viral replication and liver inflammation and compensated liver disease in adults. The recommended dose is 180µg once weekly by SCI for 48 weeks.
  • chronic hepatitis C infection in adults with co-infection with human immunodeficiency virus (HIV). The recommended dosage of peginterferon alfa-2a is 180µg SCI weekly for 48 weeks alone or in combination with oral ribavirin 800mg daily.

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RIBAVIRIN 200mg
Copegus
Tablet
Roche Products Pty Ltd.
New Indication: For the treatment, in combination with PEGASYS (peginterferon alfa-2a), of patients with chronic hepatitis C co-infected with human immunodeficiency virus (HIV-HCV co-infected). The recommended dose is 800mg daily.

PEGINTERFERON ALFA-2a / RIBAVIRIN 180µg/0.5mL and 200mg
Pegasys RBV
Solution for Injection and Tablet
Roche Products Pty Ltd.
New Indication: For the treatment of patients with chronic hepatitis C co-infected with human immunodeficiency virus (HIV-HCV co-infected). The recommended dosage of peginterferon alfa-2a is 180µg SCI weekly for 48 weeks alone or in combination with oral ribavirin 800mg daily.

OLMESARTAN MEDOXOMIL 10mg, 20mg and 40mg
Olmetec
Tablet
Pfizer Australia Pty Ltd.
New Chemical Entity: For the treatment of hypertension.

TRANDOLAPRIL / VERAPAMIL HYDROCHLORIDE 2mg/180mg and 4mg/240mg
Ziaxel
Tablet
Abbott Australasia Pty Ltd.
New Combination: For the treatment of hypertension. Treatment should not be initiated with this fixed dose combination.

LANTHANUM 250mg, 500mg, 750mg and 1000mg
Fosrenol
Chewable tablets
Orphan Australia Pty Ltd
New Chemical Entity: For the treatment of hyperphosphataemia in adults with chronic renal failure on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

LEFLUNOMIDE 10mg, 20mg and 100mg
Arava and Arabloc
Tablet
Aventis Pharma Pty Limited
New Indication: For the

  • management of polyarticular course juvenile rheumatoid (idiopathic) arthritis in patients aged 3 to 17 years.
  • treatment of active psoriatic arthritis. Leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease.

23 August 2005

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