Notice Type
Departmental
Notice Title

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 set out in the Schedule hereto:

Schedule

Product: Abiraterone
Active Ingredient: Abiraterone acetate 250mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Teva Pharmaceutical Industries Limited, Kfar Saba, Israel
   
Product: Bendamustine Sandoz
Active Ingredient: Bendamustine hydrochloride monohydrate 26.1mg equivalent to bendamustine hydrochloride 25mg
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Oncomed manufacturing a.s., Brno-Reckovice, Czech Republic
   
Product: Bendamustine Sandoz
Active Ingredient: Bendamustine hydrochloride monohydrate 104.6mg equivalent to bendamustine hydrochloride 100mg
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Oncomed manufacturing a.s., Brno-Reckovice, Czech Republic


Dated this 20th day of October 2021.

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