Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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(s): Topiramate 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Cilag AG, Schaffhausen, Switzerland
Janssen-Cilag Farmaceutica LDA, Queluz de Baixo, Queluz, Portugal
Product: Topamax
Active Ingredient(s): Topiramate 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Cilag AG, Schaffhausen, Switzerland
Janssen-Cilag Farmaceutica LDA, Queluz de Baixo, Queluz, Portugal
Product: Topamax
Active Ingredient(s): Topiramate 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Cilag AG, Schaffhausen, Switzerland
Janssen-Cilag Farmaceutica LDA, Queluz de Baixo, Queluz, Portugal
Product: Topamax
Active Ingredient(s): Topiramate 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Cilag AG, Schaffhausen, Switzerland
Janssen-Cilag Farmaceutica LDA, Queluz de Baixo, Queluz, Portugal
Product: Topamax
Active Ingredient(s): Topiramate 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Cilag AG, Schaffhausen, Switzerland
Janssen-Cilag Farmaceutica LDA, Queluz de Baixo, Queluz, Portugal
Product: Topamax
Active Ingredient(s): Topiramate 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer(s): Cilag AG, Schaffhausen, Switzerland
Janssen-Cilag Farmaceutica LDA, Queluz de Baixo, Queluz, Portugal
Dated this 24th day of May 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).