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: Angiomax
Active Ingredient(s): Bivalirudin 100mg
Dosage Form: Powder for injection
New Zealand Sponsor: The Medicines Company
Manufacturer(s): Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Product: Angiomax
Active Ingredient(s): Bivalirudin 250mg
Dosage Form: Powder for injection
New Zealand Sponsor: The Medicines Company
Manufacturer(s): Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
Product: Zyprexa Zydis
Active Ingredient(s): Olanzapine 10mg
Dosage Form: Wafer
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer(s): Scherer DDS Ltd, Blagrove, Swindon, Wiltshire, England
Product: Zyprexa Zydis
Active Ingredient(s): Olanzapine 15mg
Dosage Form: Wafer
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer(s): Scherer DDS Ltd, Blagrove, Swindon, Wiltshire, England
Product: Zyprexa Zydis
Active Ingredient(s): Olanzapine 20mg
Dosage Form: Wafer
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer(s): Scherer DDS Ltd, Blagrove, Swindon, Wiltshire, England
Product: Zyprexa Zydis
Active Ingredient(s): Olanzapine 5mg
Dosage Form: Wafer
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer(s): Scherer DDS Ltd, Blagrove, Swindon, Wiltshire, England
Dated this 4th day of July 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).