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: Prograf
Active Ingredient: Tacrolimus 0.5mg
Dosage Form: Capsule
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Fujisawa Ireland Limited, Killorglin, Co Kerry, Ireland
Product: Prograf
Active Ingredient: Tacrolimus 1mg
Dosage Form: Capsule
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Fujisawa Ireland Limited, Killorglin, Co Kerry, Ireland
Product: Prograf
Active Ingredient: Tacrolimus 5mg
Dosage Form: Capsule
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Fujisawa Ireland Limited, Killorglin, Co Kerry, Ireland
Product: Prograf
Active Ingredient: Tacrolimus 5mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Fujisawa Ireland Limited, Killorglin, Co Kerry, Ireland
Product: Remicade
Active Ingredient: Infliximab 100mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturers: Parkedale Pharmaceuticals Inc, Rochester, Michigan, United States of America
Patheon Italia SpA, Monza, Milan, Italy
Schering-Plough Company, Brinny, Innishannon, County Cork, Ireland
Dated this 26th day of January 2007.
MARK JACOBS, Acting Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).