Consent to the Distribution of New Medicines

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).

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