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: AMLO
Active Ingredient: Amlodipine besilate 13.87mg equivalent to 10mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Genpharm ULC, Ontario, Canada
Product: AMLO
Active Ingredient: Amlodipine besilate 6.94mg equivalent to 5mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Genpharm ULC, Ontario, Canada
Product: Donezil
Active Ingredient: Donepezil hydrochloride 10mg equivalent to 9.12mg donepezil base
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturers: McDermott Laboratories, t/a Gerard Laboratories, Grange Road, Dublin, Ireland
Merck Farma y Quimica SL, Poligono Merck, Mollet del Valles, Barcelona, Spain
Product: Donezil
Active Ingredient: Donepezil hydrochloride 5mg equivalent to 4.56mg donepezil base
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturers: McDermott Laboratories, t/a Gerard Laboratories, Grange Road, Dublin, Ireland
Merck Farma y Quimica SL, Poligono Merck, Mollet del Valles, Barcelona, Spain
Product: Eprex
Active Ingredient: Epoetin alfa 336µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Ltd
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Product: Nurofen Cold & Flu PE Phenylephrine
Active Ingredients: Ibuprofen 200mg
Phenylephrine hydrochloride 5mg equivalent to 4.1mg phenylephrine
Dosage Form: Film coated tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, Nottinghamshire, United Kingdom
Product: Nurofen Zavance 400 Double Strength Tablets
Active Ingredient: Ibuprofen sodium dihydrate 512mg equivalent to Ibuprofen 400mg
Dosage Form: Coated tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, Nottinghamshire, United Kingdom
Dated this 4th day of February 2009.
MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).