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: Atorvastatin Pfizer
Active Ingredient: Atorvastatin calcium 10.85mg equivalent to Atorvastatin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany
Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico
Pfizer Ireland Pharmaceuticals, County Cork, Ireland
Farmea, Angers, France
Product: Atorvastatin Pfizer
Active Ingredient: Atorvastatin calcium 21.7mg equivalent to Atorvastatin 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany
Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico
Pfizer Ireland Pharmaceuticals, County Cork, Ireland
Farmea, Angers, France
Product: Atorvastatin Pfizer
Active Ingredient: Atorvastatin calcium 43.4mg equivalent to Atorvastatin 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany
Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico
Pfizer Ireland Pharmaceuticals, County Cork, Ireland
Farmea, Angers, France
Product: Atorvastatin Pfizer
Active Ingredient: Atorvastatin calcium 86.8mg equivalent to Atorvastatin 80mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany
Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico
Pfizer Ireland Pharmaceuticals, County Cork, Ireland
Farmea, Angers, France
Product: Stivarga
Active Ingredient: Regorafenib monohydrate 41.49mg equivalent to Regorafenib 40mg
Dosage Form: Tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Pharma AG, Leverkusen, Germany
Product: Vttack
Active Ingredient: Voriconazole 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Product: Vttack
Active Ingredient: Voriconazole 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Laboratories Limited, Maharashtra State, India
Dated this 29th day of August 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).