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: Arcoxia
Active Ingredient: Etoricoxib 120mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, Elkton, Virginia, United States of America
Product: Arcoxia
Active Ingredient: Etoricoxib 60mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, Elkton, Virginia, United States of America
Product: Arcoxia
Active Ingredient: Etoricoxib 90mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, Elkton, Virginia, United States of America
Product: Cymevene
Active Ingredient: Ganciclovir sodium 545mg equivalent to 500mg ganicilovir
Dosage Form: Powder for infusion
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche Limited, Basel, Switzerland
Product: Efexor-XR
Active Ingredient: Venlafaxine hydrochloride 169.7mg equivalent to 150mg venlafaxine
Dosage Form: Modified release capsule
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Product: Efexor-XR
Active Ingredient: Venlafaxine hydrochloride 84.85mg equivalent to 75mg venlafaxine
Dosage Form: Modified release capsule
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Product: Remicade
Active Ingredient: Infliximab 100mg
Dosage Form: Powder for injection
New Zealand Sponsor: Schering-Plough Animal Health Limited
Manufacturers: Parkedale Pharmaceuticals Inc, Rochester, Michigan, United States of America
Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Product: Zoloft
Active Ingredient: Sertraline hydrochloride 111.9mg equivalent to 100mg sertraline
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturers: Pfizer Italia Srl, Borgo San Michele, Latina, Italy
Pfizer Limited, Sandwich, Kent, England
Pfizer Pharmaceuticals Limited, Dalian, China
Pfizer Pty Limited, West Ryde, New South Wales, Australia
Product: Zoloft
Active Ingredient: Sertraline hydrochloride 223.8mg equivalent to 200mg sertraline
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturers: Pfizer Limited, Sandwich, Kent, England
Pfizer Pty Limited, West Ryde, New South Wales, Australia
Product: Zoloft
Active Ingredient: Sertraline hydrochloride 56mg equivalent to 50mg sertraline
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer Laboratories Limited
Manufacturers: Pfizer Italia Srl, Borgo San Michele, Latina, Italy
Pfizer Limited, Sandwich, Kent, England
Pfizer Pharmaceuticals Limited, Dalian, China
Pfizer Pty Limited, West Ryde, New South Wales, Australia
Dated this 11th day of July 2003.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).