✨ Medicines Distribution Consent




NEW ZEALAND GAZETTE, No. 21 β€” 10 MARCH 2016

Consent to the Distribution of New Medicines

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

Product: Arcoxia
Active Ingredient: Etoricoxib 30mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme Corp, Virginia, United States of America
Frosst Iberica SA, Madrid, Spain

Product: Arcoxia
Active Ingredient: Etoricoxib 60mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme Corp, Virginia, United States of America
Frosst Iberica SA, Madrid, Spain

Product: Arcoxia
Active Ingredient: Etoricoxib 90mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme Corp, Virginia, United States of America
Frosst Iberica SA, Madrid, Spain

Product: Arcoxia
Active Ingredient: Etoricoxib 120mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme Corp, Virginia, United States of America
Frosst Iberica SA, Madrid, Spain

Product: Avastin
Active Ingredient: Bevacizumab 25mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: 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

Product: Cubicin
Active Ingredient: Daptomycin 350mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: OSO BioPharmaceuticals Manufacturing, New Mexico, United States of America
Patheon Italia SpA, Milan, Italy

Product: Cubicin
Active Ingredient: Daptomycin 500mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Hospira Inc, Kansas, United States of America
OSO BioPharmaceuticals Manufacturing, New Mexico, United States of America
Patheon Italia SpA, Milan, Italy

Dated this 4th day of March 2016.

CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2016, No 21





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
4 March 2016
Medicines, Consent, Distribution, Medicines Act 1981
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health