Consent to the Distribution of a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product:
Active Ingredient:

Dosage Form:
New Zealand Sponsor:
Manufacturers:

Onivyde
Irinotecan hydrochloride trihydrate 5mg/mL
equivalent to irinotecan 4.3mg/mL
Concentrate for infusion
Shire New Zealand Limited
Ipsen Bioscience Inc, Massachusetts, United States of America
Ajinomoto Althea Inc, California, United States of America

Dated this 14th day of September 2018.

DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

Tags

Notice Number

Schedule