Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine which was referred to the Minister of Health under the provisions of section 24 (5) of the Act and is set out in the Schedule hereto:
Schedule
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
Dated this 12th day of May 2005.
BARRY BORMAN, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).