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
Active Ingredient: Epoetin alfa 84Ág/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 16.8Ág/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 33.6Ág/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 336Ág/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Cilag AG, Schaffhausen, Switzerland
Product: Risperdal
Active Ingredient: Risperidone 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Janssen Pharmaceutica NV, Beerse, Belgium
Product: Risperdal
Active Ingredient: Risperidone 0.25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Risperdal
Active Ingredient: Risperidone 0.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Risperdal
Active Ingredient: Risperidone 1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Risperdal
Active Ingredient: Risperidone 2mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Risperdal
Active Ingredient: Risperidone 3mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Risperdal
Active Ingredient: Risperidone 4mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Product: Risperdal
Active Ingredient: Risperidone 6mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturers: Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag SpA, Borgo San Michele, Latina, Italy
Dated this 2nd day of February 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).