Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Leflunomide Sandoz
Active Ingredient: Leflunomide 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Cipla Limited, Manufacturing & Research Div., Virgonagar, Bangalore, India
Product: Leflunomide Sandoz
Active Ingredient: Leflunomide 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Cipla Limited, Manufacturing & Research Div., Virgonagar, Bangalore, India
Product: Panadeine Caplets
Active Ingredients: Codeine phosphate, anhydrous 8mg
Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Australia Pty Limited, Consumer Healthcare, Ermington, New South Wales, Australia
Product: ZolaCos CP (Combination Product)
Subcutaneous implant
Active Ingredient: Goserelin acetate 3.8mg equivalent to 3.6mg goserelin
Dosage Form: Subcutaneous implant
Manufacturer: AstraZeneca UK Limited, Macclesfield, Cheshire, United Kingdom
Tablet
Active Ingredient: Bicalutamide 50mg
Film coated tablet
Manufacturer: Corden Pharma GmbH, Plankstadt, Germany
New Zealand Sponsor: AstraZeneca Limited
Product: ZolaCos CP (Combination Product)
Subcutaneous implant
Active Ingredient: Goserelin acetate 11.34mg equivalent to 10.8mg goserelin
Dosage Form: Subcutaneous implant
Tablet
Manufacturers: AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire, United Kingdom
Active Ingredient: Bicalutamide 50mg
Film coated tablet
Manufacturer: Corden Pharma GmbH, Plankstadt, Germany
New Zealand Sponsor: AstraZeneca Limited
Dated this 30th day of March 2009.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).