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: Gemzar
Active Ingredient(s): Gemcitabine hydrochloride 1,140mg equivalent to 1000mg Gemcitabine free base
Dosage Form: Powder for infusion
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer(s): Lilly France SA, Fegersheim, France
Lilly Technology Center, Indianapolis, Indiana, United States of America
Product: Gemzar
Active Ingredient(s): Gemcitabine hydrochloride 228mg equivalent to 200mg Gemcitabine free base
Dosage Form: Powder for infusion
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer(s): Lilly France SA, Fegersheim, France
Lilly Technology Center, Indianapolis, Indiana, United States of America
Product: Lipitor
Active Ingredient(s): Atorvastatin calcium 10.85mg equivalent to 10mg Atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Parke Davis (Div. Warner Lambert NZ Limited)
Manufacturer(s): Godecke AG, Freiburg, Germany
Parke Davis Pharmaceuticals Limited, Vega Baja, Puerto Rico
Parke-Davis, Usine Pharmaceutique d'Angers, Angers Cedex 01, France
Warner-Lambert Company, Lititz, Pennsylvania, United States of America
Product: Lipitor
Active Ingredient(s): Atorvastatin calcium 21.69mg equivalent to 20mg Atorvastatin
Dosage Form: Film coated tablet
NZ Sponsor: Parke Davis (Div. Warner Lambert NZ Limited)
Manufacturer(s): Godecke AG, Freiburg, Germany
Parke Davis Pharmaceuticals Limited, Vega Baja, Puerto Rico
Parke-Davis, Usine Pharmaceutique d'Angers, Angers Cedex 01, France
Warner-Lambert Company, Lititz, Pennsylvania, United States of America
Product: Lipitor
Active Ingredient(s): Atorvastatin calcium 43.38mg equivalent to 40mg Atorvastatin
Dosage Form: Film coated tablet
NZ Sponsor: Parke Davis (Div. Warner Lambert NZ Limited)
Manufacturer(s): Godecke AG, Freiburg, Germany
Parke Davis Pharmaceuticals Limited, Vega Baja, Puerto Rico
Parke-Davis, Usine Pharmaceutique d'Angers, Angers Cedex 01, France
Warner-Lambert Company, Lititz, Pennsylvania, United States of America
Dated this 27th day of April 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).