Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new 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: Stelara
Active Ingredient: Ustekinumab 45mg
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturers: Cilag AG, Schaffhausen, Switzerland
Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Product: Stelara
Active Ingredient: Ustekinumab 90mg
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturers: Cilag AG, Schaffhausen, Switzerland
Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Dated this 19th day of October 2011.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).