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: Enbrel
Active Ingredient: Etanercept 25mg
Dosage Form: Powder for injection
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
Product: Eprex
Active Ingredient: Epoetin alfa 84µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Cilag AG, Schaffhausen, Switzerland
Janssen Pharmaceutica NV, Beerse, Belgium
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Eprex
Active Ingredient: Epoetin alfa 16.8µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Cilag AG, Schaffhausen, Switzerland
Janssen Pharmaceutica NV, Beerse, Belgium
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Eprex
Active Ingredient: Epoetin alfa 33.6µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Cilag AG, Schaffhausen, Switzerland
Janssen Pharmaceutica NV, Beerse, Belgium
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Eprex
Active Ingredient: Epoetin alfa 336µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Cilag AG, Schaffhausen, Switzerland
Product: Vfend
Active Ingredient: Voriconazole 200mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Ireland Pharmaceuticals, Dun Laoghaire, Co. Dublin, Ireland
Product: Vfend
Active Ingredient: Voriconazole 40mg/mL
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer PGM, Poca Sur Cisse, France
Product: Vfend
Active Ingredient: Voriconazole 200mg
Dosage Form: Film-coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Heinrich Mack Nachf GmbH & Co KG, Illertissen, Germany
Product: Vfend
Active Ingredient: Voriconazole 50mg
Dosage Form: Film-coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Heinrich Mack Nachf GmbH & Co KG, Illertissen, Germany
Dated this 26th day of April 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).