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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
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Product:
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Dosage Form:
New Zealand Sponsor:
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Arcoxia
Etoricoxib 30mg
Film coated tablet
Merck Sharp & Dohme (New Zealand) Limited
Merck Sharp & Dohme Corp, Virginia, United States of America
Frosst Iberica SA, Madrid, Spain
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Arcoxia
Etoricoxib 60mg
Film coated tablet
Merck Sharp & Dohme (New Zealand) Limited
Merck Sharp & Dohme Corp, Virginia, United States of America
Frosst Iberica SA, Madrid, Spain
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Arcoxia
Etoricoxib 90mg
Film coated tablet
Merck Sharp & Dohme (New Zealand) Limited
Merck Sharp & Dohme Corp, Virginia, United States of America
Frosst Iberica SA, Madrid, Spain
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Arcoxia
Etoricoxib 120mg
Film coated tablet
Merck Sharp & Dohme (New Zealand) Limited
Merck Sharp & Dohme Corp, Virginia, United States of America
Frosst Iberica SA, Madrid, Spain
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Avastin
Bevacizumab 25mg/mL
Concentrate for infusion
Roche Products (NZ) Limited
Genentech Inc, California, United States of America
F Hoffmann-La Roche Limited, Basel, Switzerland
Roche Diagnostics GmbH, Mannheim, Germany
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
Genentech Inc, Oregon, United States of America
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Cubicin
Daptomycin 350mg
Powder for infusion
Novartis New Zealand Limited
OSO BioPharmaceuticals Manufacturing, New Mexico, United States of America
Patheon Italia SpA, Milan, Italy
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Cubicin
Daptomycin 500mg
Powder for infusion
Novartis New Zealand Limited
Hospira Inc, Kansas, United States of America
OSO BioPharmaceuticals Manufacturing, New Mexico, United States of America
Patheon Italia SpA, Milan, Italy
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Dated this 4th day of March 2016.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz