Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of a New Medicine

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:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

HyperHep B
Hepatitis B immunoglobulin, human 220IU/mL
Solution for injection
Pharmaco (NZ) Limited
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 12th day of August 2016.

CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).