Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Bextra
Active Ingredient: Valdecoxib 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacia Limited Company (trading as Pharmacia)
Manufacturer: Pharmacia, Caguas, Puerto Rico
Product: Bextra
Active Ingredient: Valdecoxib 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacia Limited Company (trading as Pharmacia)
Manufacturer: Pharmacia, Caguas, Puerto Rico
Product: Bextra
Active Ingredient: Valdecoxib 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacia Limited Company (trading as Pharmacia)
Manufacturer: Pharmacia, Caguas, Puerto Rico
Dated this 9th day of May 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).