Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines 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: Atrovent
Active Ingredient: Ipratropium bromide monohydrate 0.021mg/dose equivalent to 0.020mg/dose ipratropium bromide anhydrous
Dosage Form: Aerosol inhaler, metered dose
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma KG, Ingelheim am Rhein, Germany
Product: Cipralex
Active Ingredient: Escitalopram oxalate 12.77mg equivalent to 10mg escitalopram
Dosage Form: Film coated tablet
New Zealand Sponsor: Zuellig-Pharma Limited
Manufacturer: H Lundbeck A/S, Copenhagen-Valby, Copenhagen, Denmark
Product: Cipralex
Active Ingredient: Escitalopram oxalate 19.16mg equivalent to 15mg escitalopram
Dosage Form: Film coated tablet
New Zealand Sponsor: Zuellig-Pharma Limited
Manufacturer: H Lundbeck A/S, Copenhagen-Valby, Copenhagen, Denmark
Product: Cipralex
Active Ingredient: Escitalopram oxalate 25.54mg equivalent to 20mg escitalopram
Dosage Form: Film coated tablet
New Zealand Sponsor: Zuellig-Pharma Limited
Manufacturer: H Lundbeck A/S, Copenhagen-Valby, Copenhagen, Denmark
Product: Cipralex
Active Ingredient: Escitalopram oxalate 6.39mg equivalent to 5mg escitalopram
Dosage Form: Film coated tablet
New Zealand Sponsor: Zuellig-Pharma Limited
Manufacturer: H Lundbeck A/S, Copenhagen-Valby, Copenhagen, Denmark
Product: Somac
Active Ingredient: Pantoprazole sodium 42.3mg equivalent to 40mg pantoprazole
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmacia Limited Company trading as Pharmacia
Manufacturer: Dr Rentschler Biotechnologie GmbH & Co KG, Laupheim, Germany Wasserburger Arzneimittelwerk Dr Madaus GmbH, Wasserburg, Germany
Dated this 22nd 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).