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: HyperHep B
Active Ingredient: Hepatitis B immunoglobulin, human 220IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Medica Limited Medica Pacifica Limited
Manufacturer: Talecris Biotherapeutics Inc, North Carolina, United States of America
Note: This renewed consent is valid for two years from 8 May 2012.
Dated this 16th day of February 2012.
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).