Notice Type
Departmental
Notice Title

Consent to the Distribution of Changed Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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: 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: Losec
Active Ingredient: Omeprazole 10mg
Dosage Form: Capsule
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca AB, Sodertalje, Sweden
AstraZeneca UK Limited, Headway, Great Oakley, Corby, Northamptonshire, United Kingdom
Product: Losec
Active Ingredient: Omeprazole 20mg
Dosage Form: Capsule
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca AB, Sodertalje, Sweden
AstraZeneca UK Limited, Headway, Great Oakley, Corby, Northamptonshire, United Kingdom
Product: Losec
Active Ingredient: Omeprazole 40mg
Dosage Form: Capsule
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca AB, Sodertalje, Sweden
AstraZeneca UK Limited, Headway, Great Oakley, Corby, Northamptonshire, United Kingdom
Product: Neupogen
Active Ingredient: Filgrastim 600Ág/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: F Hoffmann-La Roche AG, Basel, Switzerland
Parkedale Pharmaceuticals Inc, Rochester, Michigan, United States of America
Product: Neupogen
Active Ingredient: Filgrastim 300Ág/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: Amgen Puerto Rico Inc., Juncos, Puerto Rico
F Hoffmann-La Roche AG, Basel, Switzerland
Parkedale Pharmaceuticals Inc, Rochester, Michigan, United States of America
Dated this 24th day of October 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).