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: Apo-Ciclopirox
Active Ingredient: Ciclopirox 8%w/w
Dosage Form: Nail lacquer
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Groupe Parima, Montreal, Quebec, Canada
Product: Clopidogrel
Active Ingredient: Clopidogrel bisulfate 97.875mg equivalent to 75mg clopidogrel
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Mylanta Ranitidine 12 Hour Action
Active Ingredient: Ranitidine hydrochloride 167.5mg equivalent to 150mg ranitidine
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Salutas Pharma GmbH, Barleben, Germany
Product: Pravastatin
Active Ingredient: Pravastatin sodium 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Pravastatin
Active Ingredient: Pravastatin sodium 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Pravastatin
Active Ingredient: Pravastatin sodium 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Pravastatin
Active Ingredient: Pravastatin sodium 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Dated this 7th day of January 2010.
MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).