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: CellCept
Active Ingredient(s): Mycophenolate mofetil 250mg
Dosage Form: Capsule
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): Roche Products Limited, Welwyn Garden City, Hertfordshire, United Kingdom
Syntex Puerto Rico Inc, Humacao, Puerto Rico
Product: CellCept
Active Ingredient(s): Mycophenolate mofetil 250mg
Dosage Form: Capsule
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): Roche Products Limited, Welwyn Garden City, Hertfordshire, United Kingdom
Syntex Puerto Rico Inc, Humacao, Puerto Rico
Product: CellCept
Active Ingredient(s): Mycophenolate mofetil 500mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): Parkedale Pharmaceuticals Inc, Rochester, Michigan, United States of America
Product: CellCept
Active Ingredient(s): Mycophenolate mofetil 200mg/mL
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): Hoffmann-La Roche Inc, Nutley, New Jersey, United States of America
Product: CellCept
Active Ingredient(s): Mycophenolate mofetil 200mg/mL
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): Hoffmann-La Roche Inc, Nutley, New Jersey, United States of America
Product: CellCept
Active Ingredient(s): Mycophenolate mofetil 500mg
Dosage Form: Tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): Roche Products Limited, Welwyn Garden City, Hertfordshire, United Kingdom
Syntex Puerto Rico Inc, Humacao, Puerto Rico
Product: NovoRapid
Active Ingredient(s): Insulin aspart 100U/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer(s): Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark
Product: Simulect
Active Ingredient(s): Basiliximab 20mg
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer(s): Novartis Pharma AG, Basel, Switzerland
Dated this 23rd day of April 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).