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: Eprex (notification received 4 June 2004)
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 (notification received 4 June 2004)
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 (notification received 4 June 2004)
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 (notification received 4 June 2004)
Active Ingredient: Epoetin alfa 336µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Cilag AG, Schaffhausen, Switzerland
Product: Eprex (notification received 6 August 2004)
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 (notification received 6 August 2004)
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 (notification received 6 August 2004)
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 (notification received 6 August 2004)
Active Ingredient: Epoetin alfa 336µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Cilag AG, Schaffhausen, Switzerland
Product: ImmuCyst BCG Immunotherapeutic vaccine
Active Ingredient: Tuberculin purified protein derivative 81mg
Dosage Form: Powder for injection
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer: Aventis Pasteur Limited, Toronto, Ontario, Canada
Dated this 9th day of June 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).