Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand
of the changed medicine which was referred to the Minister of Health under the provisions of section 24 (5) of the Act and is set out in the Schedule hereto:
Schedule
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
Dated this 20th day of October 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).