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:
Manufacturers:
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Act-HIB vaccine
Haemophilus influenzae type b vaccine 10mcg
Powder for injection with diluent
Sanofi-Aventis New Zealand Limited
Sanofi Pasteur SA, Marcy L’Etoile, France
Sanofi-Aventis SpA, Frosinone, Italy
Sanofi Pasteur SA, Val-De-Reuil Cedex, France
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Augmentin
Amoxicillin sodium 530.1mg equivalent to Amoxicillin 500mg
Potassium clavulanate 119.13mg equivalent to Clavulanic acid 100mg
Powder for injection
GlaxoSmithKline (NZ) Limited
SmithKline Beecham Pharmaceuticals Limited, West Sussex, United Kingdom
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Product:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
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Augmentin
Amoxicillin sodium 1060.2mg equivalent to Amoxicillin 1000mg
Potassium clavulanate 238.25mg equivalent to Clavulanic acid 200mg
Powder for injection
GlaxoSmithKline (NZ) Limited
SmithKline Beecham Pharmaceuticals Limited, West Sussex, United Kingdom
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Dated this 13th day of May 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