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: Recormon 10000 for Reco-Pen
Active Ingredient: Epoetin beta 10,000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Recormon 20000 for Reco-Pen
Active Ingredient: Epoetin beta 20,000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Recormon
Active Ingredient: Epoetin beta 1,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 2,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 3,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 4,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 5,000IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 500IU
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Recormon
Active Ingredient: Epoetin beta 6,000IU
Dosage Form: 0.3 mL pre-filled syringe Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany
Product: Topamax Sprinkle
Active Ingredient: Topiramate 15mg
Dosage Form: Capsule
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Janssen Ortho LLC, Mamey Ward, Gurabo, Puerto Rico
McNeil Pharmaceutical (a Div. of OMJ Pharmaceuticals Inc.), Dorado, Puerto Rico
Product: Topamax Sprinkle
Active Ingredient: Topiramate 25mg
Dosage Form: Capsule
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Janssen Ortho LLC, Mamey Ward, Gurabo, Puerto Rico
McNeil Pharmaceutical (a Div. of OMJ Pharmaceuticals Inc.), Dorado, Puerto Rico
Product: Topamax Sprinkle
Active Ingredient: Topiramate 50mg
Dosage Form: Capsule
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Janssen Ortho LLC, Mamey Ward, Gurabo, Puerto Rico
McNeil Pharmaceutical (a Div. of OMJ Pharmaceuticals Inc.), Dorado, Puerto Rico
Product: Topamax
Active Ingredient: Topiramate 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Cilag AG, Schaffhausen, Switzerland
Janssen-Cilag Farmaceutica LDA, Estrada Consiglieri Pedroso, Queluz de Baixo, Queluz, Portugal
Product: Topamax
Active Ingredient: Topiramate 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Limited
Manufacturers: Cilag AG, Schaffhausen, Switzerland
Janssen-Cilag Farmaceutica LDA, Estrada Consiglieri Pedroso, Queluz de Baixo, Queluz, Portugal
Product: Topamax
Active Ingredient: Topiramate 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Cilag AG, Schaffhausen, Switzerland
Janssen-Cilag Farmaceutica LDA, Estrada Consiglieri Pedroso, Queluz de Baixo, Queluz, Portugal
Product: Topamax
Active Ingredient: Topiramate 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Cilag AG, Schaffhausen, Switzerland
Janssen-Cilag Farmaceutica LDA, Estrada Consiglieri Pedroso, Queluz de Baixo, Queluz, Portugal
Product: Topamax
Active Ingredient: Topiramate 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Cilag AG, Schaffhausen, Switzerland
Janssen-Cilag Farmaceutica LDA, Estrada Consiglieri Pedroso, Queluz de Baixo, Queluz, Portugal
Product: Topamax
Active Ingredient: Topiramate 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Cilag AG, Schaffhausen, Switzerland
Janssen-Cilag Farmaceutica LDA, Estrada Consiglieri Pedroso, Queluz de Baixo, Queluz, Portugal
Dated this 4th day of April 2004.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the
6th day of July 2001).