✨ Medicines Consent Notifications




5 MAY 2005

NEW ZEALAND GAZETTE, No. 76

1793

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



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2005, No 76


Gazette.govt.nz PDF NZ Gazette 2005, No 76





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of Changed Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
Medicines, Distribution Consent, Medicines Act 1981