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
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Apo-Zoledronic Acid
Zoledronic acid monohydrate 0.0533mg/mL
equivalent to zoledronic acid anhydrous 0.05mg/mL
Solution for injection
Apotex NZ Limited
Sanochemia Pharmazeutika AG, Neufeld an der Leitha, Austria
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Metformin Mylan
Metformin hydrochloride 1000mg
Film coated tablet
Mylan New Zealand Limited
Mylan Laboratories Limited, Nashik, India
Granules India Limited, Hyderabad, India
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Zytiga
Abiraterone acetate 500mg
Film coated tablet
Janssen-Cilag (New Zealand) Limited
Patheon France SA, Bourgoin Jallieu, France
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Dated this 15th day of September 2017.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz