Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Active Ingredient:
Dosage Form: New Zealand Sponsor: Manufacturer:
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Apo-Zoledronic Acid Zoledronic acid monohydrate 0.0426mg/mL equivalent to zoledronic acid 0.04mg/mL Solution for infusion Apotex NZ Limited Sanochemia Pharmazeutika AG, Neufeld an der Leitha, Austria
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Product: Active Ingredient: Dosage Form: New Zealand Sponsor: Manufacturer:
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HyperHep B Hepatitis B immunoglobulin, human 220IU/mL Solution for injection Medi’Ray New Zealand Limited Grifols Therapeutics Inc, North Carolina, United States of America
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Dated this 2nd day of June 2017.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).