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: | Zejula |
Active Ingredient: | Niraparib tosilate monohydrate 159.4mg equivalent to niraparib 100mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
Manufacturer: | Quotient Sciences – Philadelphia LLC, Pennsylvania, United States of America |
Dated this 14th day of March 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).