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: Azopt
Active Ingredient(s): Brinzolamide 1%
Dosage Form: Eye drops, suspension
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Alcon Couvreur SA, Puurs, Belgium
Product: Clopine
Active Ingredient(s): Clozapine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Douglas Manufacturing (Division of Douglas Pharmaceuticals Limited, Lincoln, Auckland)
Product: Clopine
Active Ingredient(s): Clozapine 25mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer(s): Douglas Manufacturing (Division of Douglas Pharmaceuticals Limited, Lincoln, Auckland)
Product: ReFacto
Active Ingredient(s): Factor VIII (recombinant) 1,000IU equivalent to 76 mcg
Dosage Form: Powder for injection
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer(s): Pharmacia & Upjohn AB, Stockholm, Sweden
Product: ReFacto
Active Ingredient(s): Factor VIII (recombinant) 250IU equivalent to 19 mcg
Dosage Form: Powder for injection
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer(s): Pharmacia & Upjohn AB, Stockholm, Sweden
Product: ReFacto
Active Ingredient(s): Factor VIII (recombinant) 500IU equivalent to 38 mcg
Dosage Form: Powder for injection
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer(s): Pharmacia & Upjohn AB, Stockholm, Sweden
Dated this 15th day of November 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).