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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

Product: Ofev
Active Ingredient: Nintedanib esilate 120.4mg equivalent to nintedanib 100mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Catalent Germany Eberbach GmbH, Eberbach, Germany
   
Product: Ofev
Active Ingredient: Nintedanib esilate 180.6mg equivalent to nintedanib 150mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Catalent Germany Eberbach GmbH, Eberbach, Germany
   
Product: Zerbaxa
Active Ingredients: Ceftolozane sulfate 1147mg equivalent to ceftolozane 1000mg
Tazobactam sodium 537mg equivalent to tazobactam 500mg
Dosage Form: Powder for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Steri-Pharma LLC, New York, United States of America


Dated this 15th day of November 2021.

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