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: Children’s Claratyne
Active Ingredient: Loratadine 5mg
Dosage Form: Chewable tablet
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturers: Schering Corporation (USA), Kenilworth, New Jersey, United States of America
Product: Nurofen Zavance Caplets (General Sale)
Active Ingredient: Ibuprofen sodium dihydrate 256mg equivalent to Ibuprofen 200mg
Dosage Form: Coated tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, Nottinghamshire, United Kingdom
Product: Nurofen Zavance Caplets (Pharmacy Only)
Active Ingredient: Ibuprofen sodium dihydrate 256mg equivalent to Ibuprofen 200mg
Dosage Form: Coated tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, Nottinghamshire, United Kingdom
Product: Nurofen Zavance Tablets (General Sale)
Active Ingredient: Ibuprofen sodium dihydrate 256mg equivalent to Ibuprofen 200mg
Dosage Form: Coated tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, Nottinghamshire, United Kingdom
Product: Nurofen Zavance Tablets (Pharmacy Only)
Active Ingredient: Ibuprofen sodium dihydrate 256mg equivalent to Ibuprofen 200mg
Dosage Form: Coated tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, Nottinghamshire, United Kingdom
Product: Spiriva Respimat
Active Ingredient: Tiotropium bromide monohydrate 3.125µg/dose equivalent to Tiotropium 2.5µg/dose
Dosage Form: Solution for inhalation
New Zealand Sponsor: Boehringer Ingelheim (NZ) Ltd
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany
Dated this 12th day of December 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).