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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Topamax
Active Ingredient: Topiramate 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Cilag AG, Schaffhausen, Switzerland
Product: Topamax
Active Ingredient: Topiramate 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Cilag AG, Schaffhausen, Switzerland
Product: Topamax
Active Ingredient: Topiramate 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Cilag AG, Schaffhausen, Switzerland
Product: Topamax
Active Ingredient: Topiramate 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Cilag AG, Schaffhausen, Switzerland
Product: Topamax Sprinkle
Active Ingredient: Topiramate 15mg
Dosage Form: Capsule
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico
Product: Topamax Sprinkle
Active Ingredient: Topiramate 25mg
Dosage Form: Capsule
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico
Product: Topamax Sprinkle
Active Ingredient: Topiramate 50mg
Dosage Form: Capsule
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico
Dated this 24th 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).