Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:
Schedule
Product: Zemaira
Active Ingredient: alpha1-Proteinase inhibitor 1000mg
Dosage Form: Injection with diluent
New Zealand Sponsor: bioCSL (NZ) Limited
Manufacturer: CSL Behring LLC, Illinois, United States of America
Note: This renewed consent is valid for two years from 24 March 2013.
Dated this 7th day of February 2013.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).