Pursuant to section 23(1) 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: Zemaira
Active Ingredient: alpha1-Proteinase inhibitor 1000mg
Dosage Form: Injection with diluent
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: CSL Behring LLC, Illinois, United States of America
Note: This consent is valid for two years from the date of publication of this notice.
Dated this 17th day of March 2011.
PAT TUOHY, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).