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: Cerezyme (notification received on 8 August 2003)
Active Ingredient: Imiglucerase-rch 212U
Dosage Form: Powder for infusion
New Zealand Sponsor: Medra Services Limited
Manufacturer: Genzyme Corporation, Allston, Massachusetts, United States of America
Note: This medicine has provisional consent that expires on 29 July 2005.
Product: Cerezyme (notification received on 25 March 2004)
Active Ingredient: Imiglucerase-rch 212U
Dosage Form: Powder for infusion
New Zealand Sponsor: Medra Services Limited
Manufacturer: Genzyme Corporation, Allston, Massachusetts, United States of America
Note: This medicine has provisional consent that expires on 29 July 2005.
Product: Gemzar
Active Ingredient: Gemcitabine hydrochloride 1,140mg equivalent to 1,000mg 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., 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: Hepatitis B Immunoglobulin 100IU
Active Ingredient: Hepatitis B immunoglobulin, human 160mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: CSL New Zealand Limited
Manufacturer: CSL Limited, Broadmeadows, Victoria, Australia
Product: Hepatitis B Immunoglobulin 400IU
Active Ingredient: Hepatitis B immunoglobulin, human 160mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: CSL New Zealand Limited
Manufacturer: CSL Limited, Broadmeadows, Victoria, Australia
Product: Invanz
Active Ingredient: Ertapenem sodium 209.2mg/mL equivalent to 200mg/mL ertapenem free acid
Dosage Form: Powder for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Laboratoires Merck Sharp & Dohme - Chibret, (Mirabel Plant), Clermont-Ferrand, Cedex 9, France
Product: Normal Immunoglobulin
Active Ingredient: Immunoglobulin G 160mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: CSL New Zealand Limited
Manufacturer: CSL Limited, Broadmeadows, Victoria, Australia
Product: Rh(D) Immunoglobulin
Active Ingredient: Anti-D [Rho] immunoglobulin 250IU
Dosage Form: Solution for injection
New Zealand Sponsor: CSL New Zealand Limited
Manufacturer: CSL Limited, Broadmeadows, Victoria, Australia
Product: Rh(D) Immunoglobulin
Active Ingredient: Anti-D [Rho] immunoglobulin 625IU
Dosage Form: Solution for injection
New Zealand Sponsor: CSL New Zealand Limited
Manufacturer: CSL Limited, Broadmeadows, Victoria, Australia
Product: Tetanus Immunoglobulin
Active Ingredient: Tetanus immunoglobulin, human 250IU
Dosage Form: Solution for injection
New Zealand Sponsor: CSL New Zealand Limited
Manufacturer: CSL Limited, Broadmeadows, Victoria, Australia
Product: Zoster Immunoglobulin
Active Ingredient: Zoster immunoglobulin, human 100IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: CSL New Zealand Limited
Manufacturer: CSL Limited, Broadmeadows, Victoria, Australia
Dated this 28th day of April 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).