Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Fabrazyme
Active Ingredient: Agalsidase beta 35mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Pharmacy Retailing trading as Healthcare Logistics
Manufacturer: Genzyme Corporation, Allston, Massachusetts, United States of America
Note: This consent is valid for two years from 20 October 2007.
Product: Fabrazyme
Active Ingredient: Agalsidase beta 5.5mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Pharmacy Retailing trading as Healthcare Logistics
Manufacturer: Genzyme Corporation, Allston, Massachusetts, United States of America
Note: This consent is valid for two years from 24 January 2008.
Dated this 1st day of February 2008.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).