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).