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:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Dulcolax SP Drops
Sodium picosulfate monohydrate 7.5mg/mL
Oral solution
Sanofi-Aventis New Zealand Limited
Istituto de Angeli SrL, Florence, Italy
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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Isentress
Raltegravir potassium 434.4mg equivalent to raltegravir 400mg
Film coated tablet
Merck Sharp & Dohme (New Zealand) Limited
MSD International GmbH (Singapore Branch), Singapore, Singapore
MSD International GmbH (Ireland), Clonmel, Ireland
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Zinforo
Ceftaroline fosamil acetic acid solvate monohydrate 668.4mg
equivalent to ceftaroline fosamil 600mg
Powder for injection
Pfizer New Zealand Limited
Facta Farmaceutici SpA, Teramo, Italy
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Dated this 18th day of May 2018.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz