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
Product: Clopidogrel
Active Ingredient: Clopidogrel bisulfate 97.875mg equivalent to Clopidogrel 75mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Air Flow Products Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Hayfexo
Active Ingredient: Fexofenadine hydrochloride 120mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy's New Zealand Limited
Manufacturer: Dr Reddy's Laboratories Limited, Andhra Pradesh, India
Product: Hayfexo
Active Ingredient: Fexofenadine hydrochloride 180mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy's New Zealand Limited
Manufacturer: Dr Reddy's Laboratories Limited, Andhra Pradesh, India
Product: Sumatriptan
Active Ingredient: Sumatriptan succinate 69.99mg equivalent to Sumatriptan 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Air Flow Products Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Sumatriptan
Active Ingredient: Sumatriptan succinate 139.98mg equivalent to Sumatriptan 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Air Flow Products Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Dated this 7th day of February 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).