Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the following new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Konakion MM
Active Ingredient: Phytomenadione 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: Cenexi SAS, Fontenay-sous-Bois, France
F Hoffmann-La Roche Limited, Basel, Switzerland
Product: Lipex
Active Ingredient: Simvastatin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck & Co Inc, West Point, Pennsylvania, United States of America
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia
Product: Lipex
Active Ingredient: Simvastatin 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck & Co Inc, West Point, Pennsylvania, United States of America
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia
Product: Lipex
Active Ingredient: Simvastatin 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck & Co Inc, West Point, Pennsylvania, United States of America
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia
Product: Lipex
Active Ingredient: Simvastatin 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck & Co Inc, West Point, Pennsylvania, United States of America
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia
Product: Lipex
Active Ingredient: Simvastatin 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Product: Pentasa
Active Ingredient: Mesalazine 1g
Dosage Form: Modified release granules
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturers: Ferring A/S (Denmark), Vanlose, Denmark
Ferring International Centre SA, Chemin de la Vergognausaz, Switzerland
Product: Pentasa
Active Ingredient: Mesalazine 2g
Dosage Form: Modified release granules
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturers: Ferring A/S (Denmark), Vanlose, Denmark
Ferring International Centre SA, Chemin de la Vergognausaz, Switzerland
QPharma AB, Malmo, Sweden
Inpac AB, Aldermansgatan, Lund, Sweden
Product: Pentasa
Active Ingredient: Mesalazine 250mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturers: Ferring A/S (Denmark), Vanlose, Denmark
Pharbil Pharma GmbH Limited, Bielefeld, Germany
Product: Pentasa
Active Ingredient: Mesalazine 500mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturers: Ferring A/S (Denmark), Vanlose, Denmark
Ferring International Centre SA, Chemin de la Vergognausaz, Switzerland
Pharbil Pharma GmbH Limited, Bielefeld, Germany
Product: Vytorin
Active Ingredients: Ezetimibe 10mg
Simvastatin 10mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme (Singapore) Limited, Singapore, Singapore
Merck Sharp & Dohme SpA, Pavia, Italy
Product: Vytorin
Active Ingredients: Ezetimibe 10mg
Simvastatin 20mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme (Singapore) Limited, Singapore, Singapore
Merck Sharp & Dohme SpA, Pavia, Italy
Product: Vytorin
Active Ingredients: Ezetimibe 10mg
Simvastatin 40mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme (Singapore) Limited, Singapore, Singapore
Merck Sharp & Dohme SpA, Pavia, Italy
Product: Vytorin
Active Ingredients: Ezetimibe 10mg
Simvastatin 80mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme (Singapore) Limited, Singapore, Singapore
Merck Sharp & Dohme SpA, Pavia, Italy
Dated this 16th day of October 2008.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).