Notice Title

Consent to the Distribution of New Medicines

Publication Date
24 Aug 2023

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2023-go3876
Title
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File Type and Size
PDF (33 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: Mekinist
Active Ingredient: Trametinib dimethyl sulfoxide 0.5635mg equivalent to trametinib 0.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
GlaxoSmithKline Manufacturing SpA, Parma, Italy
   
Product: Mekinist
Active Ingredient: Trametinib dimethyl sulfoxide 2.254mg equivalent to trametinib 2mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
GlaxoSmithKline Manufacturing Spa, Parma, Italy


Dated this 22nd day of August 2023.

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