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: Carvedilol
Active Ingredient: Carvedilol 3.125mg
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Maharashtra State, India
Product: Carvedilol
Active Ingredient: Carvedilol 6.25mg
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Maharashtra State, India
Product: Carvedilol
Active Ingredient: Carvedilol 12.5mg
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Maharashtra State, India
Product: Carvedilol
Active Ingredient: Carvedilol 25mg
Dosage Form: Tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Maharashtra State, India
Product: Strepsils Warm
Active Ingredients: Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Dosage Form: Lozenge
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottinghamshire, United Kingdom
Product: Tiramate
Active Ingredient: Topiramate 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Pharmaceuticals ULC, Ontario, Canada
Product: Tiramate
Active Ingredient: Topiramate 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Pharmaceuticals ULC, Ontario, Canada
Product: Tiramate
Active Ingredient: Topiramate 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Pharmaceuticals ULC, Ontario, Canada
Product: Tiramate
Active Ingredient: Topiramate 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Pharmaceuticals ULC, Ontario, Canada
Dated this 26th day of February 2010.
ANTHONY HILL, Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).