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: Durogesic 100µg/h
Active Ingredient: Fentanyl 16.8mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Alza Ireland Limited, Cashel, Co. Tipperary, Ireland
Product: Durogesic 25µg/h
Active Ingredient: Fentanyl 4.2mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Alza Ireland Limited, Cashel, Co. Tipperary, Ireland
Product: Durogesic 50µg/h
Active Ingredient: Fentanyl 8.4mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Alza Ireland Limited, Cashel, Co. Tipperary, Ireland
Product: Durogesic 75µg/h
Active Ingredient: Fentanyl 12.6mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Alza Ireland Limited, Cashel, Co. Tipperary, Ireland
Product: Gemzar
Active Ingredient: Gemcitabine hydrochloride 1140mg equivalent to 1000mg Gemcitabine free base
Dosage Form: Powder for infusion
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturers: Lilly France SAS, Fegersheim, France
Lilly Technology Center, Indianapolis, Indiana, United States of America
VIANEX SA, 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 SAS, Fegersheim, France
Lilly Technology Center, Indianapolis, Indiana, United States of America
Dated this 5th day of May 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).