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: Hyzaar
Active Ingredients: Hydrochlorothiazide 12.5mg
Losartan potassium 50mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Bristol-Myers Squibb Pharma Company, Garden City, New York, United States of America
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Product: Remicade (notification received 26 August 2003)
Active Ingredient: Infliximab 100mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Schering-Plough Animal Health Limited
Manufacturers: Parkedale Pharmaceuticals Inc, Rochester, Michigan, United States of America
Patheon Italia SpA, Stucchi, Monza, Italy
Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: Remicade (notification received 7 April 2004)
Active Ingredient: Infliximab 100mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Schering-Plough Animal Health Limited
Manufacturers: Parkedale Pharmaceuticals Inc, Rochester, Michigan, United States of America
Patheon Italia SpA, Stucchi, Monza, Italy
Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: Remicade (notification received 8 April 2004)
Active Ingredient: Infliximab 100mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Schering-Plough Animal Health Limited
Manufacturers: Parkedale Pharmaceuticals Inc, Rochester, Michigan, United States of America
Patheon Italia SpA, Stucchi, Monza, Italy
Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Dated this 16th day of November 2004.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).