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: Gemcitabine hydrochloride 1,140mg equivalent to 1000mg Gemcitabine free base
Dosage Form: Powder for infusion
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturers: Lilly France S.A.S., Fegersheim, France
Lilly Technology Center, Indianapolis, Indiana, United States of America
VIANEX S.A., Plant C, Pallini Attikis, Greece
Product: Gemzar
Active Ingredient: Gemcitabine hydrochloride 228mg equivalent to 200mg Gemcitabine free base
Dosage Form: Powder for infusion
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturers: Lilly France S.A.S., Fegersheim, France
Lilly Technology Center, Indianapolis, Indiana, United States of America
Product: Lipitor
Active Ingredient: Atorvastatin calcium 10.85mg equivalent to 10mg atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Godecke GmbH, Freiburg, Germany
Parke Davis Pharmaceuticals Limited, Vega Baja, Puerto Rico
Parke-Davis, Usine Pharmaceutique d’Angers, France
Pfizer Ireland Pharmaceuticals, Ringaskiddy, County Cork, Ireland
Warner-Lambert Company, Lititz, Pennsylvania, United States of America
Product: Lipitor
Active Ingredient: Atorvastatin calcium 21.69mg equivalent to 20mg atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Godecke GmbH, Freiburg, Germany
Parke Davis Pharmaceuticals Limited, Vega Baja, Puerto Rico
Parke-Davis, Usine Pharmaceutique d’Angers, France
Pfizer Ireland Pharmaceuticals, Ringaskiddy, County Cork, Ireland
Warner-Lambert Company, Lititz, Pennsylvania, United States of America
Product: Lipitor
Active Ingredient: Atorvastatin calcium 43.38mg equivalent to 40mg atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Godecke GmbH, Freiburg, Germany
Parke Davis Pharmaceuticals Limited, Vega Baja, Puerto Rico
Parke-Davis, Usine Pharmaceutique d’Angers, France
Pfizer Ireland Pharmaceuticals, Ringaskiddy, County Cork, Ireland
Warner-Lambert Company, Lititz, Pennsylvania, United States of America
Product: Lipitor
Active Ingredient: Atorvastatin calcium 86.76mg equivalent to 80mg atorvastatin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Parke Davis Pharmaceuticals Limited, Vega Baja, Puerto Rico
Product: Lucrin Depot 1-month
Active Ingredient: Leuprorelin acetate 3.75mg
Dosage Form: Powder for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Takeda Chemical Industries Limited, Fugisawa-shi, Japan
Product: Lucrin Depot 3-month
Active Ingredient: Leuprorelin acetate 11.25mg
Dosage Form: Powder for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Takeda Chemical Industries Limited, Fugisawa-shi, Japan
Dated this 12th day of October 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).