Notice Title

Consent to the Distribution of New Medicines

Publication Date
7 Aug 2025

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2025-go4294
Title
View PDF
File Type and Size
PDF (22 KB)

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: Children’s Claratyne (Bubblegum flavour)
Active Ingredient: Loratadine 5mg
Dosage Form: Chewable tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturers: Dragenopharm, Tittmoning, Germany
Bayer Healthcare LLC, Pennsylvania, United States of America
 
Product: Children’s Claratyne
Active Ingredient: Loratadine 5mg
Dosage Form: Chewable tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Healthcare LLC, Pennsylvania, United States of America
 
Product: Nintedanib-Teva
Active Ingredient: Nintedanib esilate 120.4mg equivalent to Nintedanib 100mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Lotus Pharmaceutical Co Limited, Nantou City, Taiwan
 
Product: Nintedanib-Teva
Active Ingredient: Nintedanib esilate 180.6mg equivalent to Nintedanib 150mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Lotus Pharmaceutical Co Limited, Nantou City, Taiwan


Dated this 4th day of August 2025.

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