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: 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
Dated this 27th day of April 2007.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).