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: Concerta Extended Release Tablets
Active Ingredient: Methylphenidate hydrochloride 18mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Alza Corporation, Mountain View, California, United States of America
Alza Corporation, Vacaville, California, United States of America
Product: Concerta Extended Release Tablets
Active Ingredient: Methylphenidate hydrochloride 36mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Alza Corporation, Mountain View, California, United States of America
Alza Corporation, Vacaville, California, United States of America
Product: Concerta Extended Release Tablets
Active Ingredient: Methylphenidate hydrochloride 54mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Alza Corporation, Mountain View, California, United States of America
Alza Corporation, Vacaville, California, United States of America
Product: Efexor-XR
Active Ingredient: Venlafaxine hydrochloride 169.7mg equivalent to 150mg venlafaxine
Dosage Form: Modified release capsule
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Product: Efexor-XR
Active Ingredient: Venlafaxine hydrochloride 84.85mg equivalent to 75mg venlafaxine
Dosage Form: Modified release capsule
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Product: Fragmin
Active Ingredient: Dalteparin sodium 10,000IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Recip AB, Stockholm, Sweden
Product: Fragmin
Active Ingredient: Dalteparin sodium 12,500IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Recip AB, Stockholm, Sweden
Product: Fragmin
Active Ingredient: Dalteparin sodium 25,000IU/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Recip AB, Stockholm, Sweden
Product: Pegasys
Active Ingredient: Peginterferon alfa-2a 270µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche Ltd, Basel, Switzerland
Product: Pegasys
Active Ingredient: Peginterferon alfa-2a 360µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche Ltd, Basel, Switzerland
Product: Xeloda
Active Ingredient: Capecitabine 150mg
Dosage Form: Film-coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: Hoffmann-La Roche Inc, Nutley, New Jersey, United States of America
Roche Products Limited, Welwyn Garden City, Hertfordshire, United Kingdom
Product: Xeloda
Active Ingredient: Capecitabine 500mg
Dosage Form: Film-coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: Hoffmann-La Roche Inc, Nutley, New Jersey, United States of America
Roche Products Limited, Welwyn Garden City, Hertfordshire, United Kingdom
Dated this 14th day of April 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).