Notice Type
Departmental
Notice Title

Consent to the Distribution of 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 medicines set out in the Schedule hereto:

Schedule

Product: Chloramphenicol 1% w/w eye ointment
Active Ingredient: Chloramphenicol 10mg/g
Dosage Form: Eye ointment
New Zealand Sponsor: Devatis Limited
Manufacturer: Deva Holding AS, Tekirdag, Turkey
   
Product: Fotivda
Active Ingredient: Tivozanib hydrochloride monohydrate 1mg equivalent to tivozanib 890mcg
Dosage Form: Capsule
New Zealand Sponsor: Emerge Health New Zealand Limited
Manufacturer: Catalent CTS Inc, Missouri, United States of America
   
Product: Fotivda
Active Ingredient: Tivozanib hydrochloride monohydrate 1.5mg equivalent to tivozanib 1340mcg
Dosage Form: Capsule
New Zealand Sponsor: Emerge Health New Zealand Limited
Manufacturer: Catalent CTS Inc, Missouri, United States of America
   
Product: Mebeverine
Active Ingredient: Mebeverine hydrochloride 135mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Generic Partners (NZ) Limited
Manufacturer: RA Chem Pharma Limited, Hyderabad, India
   

Dated this 19th day of July 2019.

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