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: NovoNorm
Active Ingredient(s): Repaglinide 0.5mg
Dosage Form: Tablet
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer(s): Boehringer Ingelheim Pharma KG, Ingelheim am Rhein, Germany
Product: NovoNorm
Active Ingredient(s): Repaglinide 1mg
Dosage Form: Tablet
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer(s): Boehringer Ingelheim Pharma KG, Ingelheim am Rhein, Germany
Product: NovoNorm
Active Ingredient(s): Repaglinide 2mg
Dosage Form: Tablet
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer(s): Boehringer Ingelheim Pharma KG, Ingelheim am Rhein, Germany
Product: Xeloda
Active Ingredient(s): Capecitabine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): Roche Products Limited, Welwyn Garden City, Hertfordshire, United Kingdom
Note: This product has provisional consent.
Product: Xeloda
Active Ingredient(s): Capecitabine 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): Roche Products Limited, Welwyn Garden City, Hertfordshire, United Kingdom
Note: This product has provisional consent.
Dated this 11th day of May 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).