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ADEC 231st meeting resolutions, 4-5 December 2003

Australian Drug Evaluation Committee

4 December 2003

Published in the Commowealth of Australia Gazette, No. GN 1, 7 January 2004





The 231st (2003/6) meeting of the Australian Drug Evaluation Committee (ADEC) (4-5 December 2003) 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.

Powder for injection 12 IU (4mg), vial with diluent vial.
Novo Nordisk Pharmaceuticals Pty. Ltd
New Indication: For the treatment of severe growth failure due to intrauterine growth retardation (i.e., children born small for gestational age (birth weight and/or length < -2SD) without spontaneous catch up growth by 2 years of age.

Oestradiol hemihydrate- ESTRADOT
Transdermal Patches 25, 37.5, 50, 75 and 100 µg/day
Novartis Pharmaceuticals Australia Pty Ltd
New Strength/Generic Application: Indicated for short-term treatment of symptoms of oestrogen deficiency due to the menopause, whether natural or surgically induced.

Olive oil and soya oil - CLINOLEIC 20%
Sterile emulsion for injection, 100mL, 250mL, 350mL, 500mL, 1000mL in bags and 100mL, 125mL, 250mL, 500mL and 1000mL in bottles.
Baxter Healthcare Pty. Limited
New Route of Administration/New Fixed Combination: Indicated for parenteral nutrition when oral or enteral nutrition is impossible, insufficient or contraindicated.

Atomoxetine Hydrochloride - STRATTERA
Capsules 5mg, 10mg, 18mg, 25mg, 40mg, and 60mg
Eli Lilly Australia Pty Limited
New Chemical Entity: For the treatment of attention deficit hyperactivity disorder (ADHD) as defined by DSM-IV criteria in children 6 years of age and older, adolescents and adults.

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Atazanavir sulfate - REYATAZ
Capsules 100mg, 150mg & 200mg
Bristol-Myers Squibb Australia Pty. Ltd
New Chemical Entity: Atazanavir sulfate is indicated for the treatment of HIV-1 infection, in combination with other antiretroviral agents.

Palivizumab - SYNAGIS
Powder for injection 50mg/0.5mL & 100mg/1mL per vial with diluent
Abbott Australasia Pty Ltd
New Indication: Synagis (palivizumab) is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease. Safety and efficacy were established in children with bronchopulmonary dysplasia (BPD), infants with a history of prematurity (gestational age < 35 weeks at birth), and children with haemodynamically significant congenital heart disease (CHD) (See Clinical Trials).

Pravastatin - PRAVACHOL
Tablets 5mg, 10mg, 20mg and 40mg
Bristol-Myers Squibb Pharmaceuticals
New Indication: PRAVACHOL is indicated as an adjunct to diet and lifestyle modification for the treatment of Heterozygous Familial Hypercholesterolaemia in children and adolescent patients ages 8 years and older (see Clinical Trials).

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Treprostinil sodium - REMODULIN
Solution for injection, 1mg/mL, 2.5mg/mL, 5mg/mL & 10mg/mL in 20mL multi-use vials
Orphan Australia Pty Ltd
New Chemical Entity: Remodulin is indicated as a continuous subcutaneous infusion for the treatment of pulmonary arterial hypertension in patients with NYHA class III-IV to diminish symptoms associated with exercise.

Fondaparinux - ARIXTRA
Sterile solution for injection, 2.5mg prefilled syringe
Sanofi-Synthelabo Australia Pty Ltd
New Directions for Use: Treatment should be continued for at least 7±2 days. In cases where the risk of VTE persists, treatment can be extended for as long as indicated up to a maximum of 31 days therapy.

Capsule, immediate release 20mg and 40mg & tablet, sustained release 80mg
Novartis Pharmaceuticals Australia Pty Ltd
New Indication: For the prevention of major adverse cardiac events in patients with coronary heart disease who have undergone successful coronary transcatheter therapy.

Candesartan - ATACAND
Tablets 4mg, 8mg, and 16mg
AstraZeneca Pty Ltd
Amendment of Product Information: Inclusion of a description of the SCOPE study and a description of the CALM study, correcting the SCOPE study for secondary endpoints and correcting the CALM study for multiple comparisons.

Professor Martin Tattersall
Australian Drug Evaluation Committee

16 December 2003

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