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: HyperHep B
Active Ingredient: Hepatitis B immunoglobulin, human 220IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Medi'Ray New Zealand Limited
Manufacturer: Grifols Therapeutics Inc, North Carolina, United States of America
Note: This consent is valid for two years from the date of publication of this notice.
Dated this 26th day of June 2014.
SUSAN MARTINDALE, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).