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-Pravastatin
Active Ingredient: Pravastatin sodium 10mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Etobicoke, Ontario, Canada
Product: Apo-Pravastatin
Active Ingredient: Pravastatin sodium 20mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Etobicoke, Ontario, Canada
Product: Apo-Pravastatin
Active Ingredient: Pravastatin sodium 40mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Etobicoke, Ontario, Canada
Product: Apo-Risperidone
Active Ingredient: Risperidone 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Richmond Hill, Ontario, Canada
Product: Asamax 500
Active Ingredient: Mesalazine 500mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: QPharma AB, Malmo, Sweden
Product: Exforge
Active Ingredients: Amlodipine besilate 13.87mg equivalent to amlodipine 10mg
Valsartan 160mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Exforge
Active Ingredients: Amlodipine besilate 6.94mg equivalent to 5mg amlodipineValsartan 160mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Product: Exforge
Active Ingredients: Amlodipine besilate 6.94mg equivalent to 5mg amlodipineValsartan 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Product: Terbinafine
Active Ingredient: Terbinafine hydrochloride 281.25mg equivalent to 250mg terbinafine
Dosage Form: Tablet
New Zealand Sponsor: Affordable Healthcare Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Bachepalli, Andhra Pradesh, India
Dated this 3rd day of October 2008.
MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).