Notice Title

Consent to the Distribution of New Medicines

Publication Date
12 Dec 2024

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2024-go6336
Title
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File Type and Size
PDF (36 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 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: Ocrevus
Active Ingredient: Ocrelizumab 300mg
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: Roche Diagnostics GmbH, Mannheim, Germany
F Hoffmann-La Roche AG, Kaiseraugst. Switzerland
   
Product: Trajentamet (2.5mg/500mg)
Active Ingredients: Linagliptin 2.5mg Metformin hydrochloride 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Dragenopharm, Apotheker Puschl GmbH & Co. KG, Tittmoning, Germany
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
   
Product: Trajentamet (2.5mg/850mg)
Active Ingredients: Linagliptin 2.5mg Metformin hydrochloride 850mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Dragenopharm, Apotheker Puschl GmbH & Co. KG, Tittmoning, Germany
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
   
Product: Trajentamet (2.5mg/1000mg)
Active Ingredients: Linagliptin 2.5mg Metformin hydrochloride 1000mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturers: Dragenopharm, Apotheker Puschl GmbH & Co. KG, Tittmoning, Germany
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany


Dated this 6th day of December 2024.

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