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).
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