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: | Imbruvica |
Active Ingredient: | Ibrutinib 140mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
Manufacturers: | Cilag AG, Schaffhausen, Switzerland Catalent CTS Inc, Missouri, United States of America |
Product: | Imbruvica |
Active Ingredient: | Ibrutinib 140mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
Manufacturers: | Cilag AG, Schaffhausen, Switzerland Catalent CTS Inc, Missouri, United States of America |
Product: | Imbruvica |
Active Ingredient: | Ibrutinib 280mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
Manufacturers: | Cilag AG, Schaffhausen, Switzerland Catalent CTS Inc, Missouri, United States of America |
Product: | Imbruvica |
Active Ingredient: | Ibrutinib 420mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
Manufacturers: | Cilag AG, Schaffhausen, Switzerland Catalent CTS Inc, Missouri, United States of America |
Product: | Imbruvica |
Active Ingredient: | Ibrutinib 560mg |
Dosage Form: | Film coated tablet |
New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
Manufacturers: | Cilag AG, Schaffhausen, Switzerland Catalent CTS Inc, Missouri, United States of America |
Dated this 23rd day of September 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).