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: 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 13th day of February 2004.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the
6th day of July 2001).