Notice Title

Consent to the Distribution of New Medicines

Publication Date
19 Dec 2024

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2024-go6537
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: ENHERTU
Active Ingredient: Trastuzumab deruxtecan 100mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: Baxter Oncology GmbH, Halle-Kunsebeck Westfalen, Germany
   
Product: Keytruda
Active Ingredient: Pembrolizumab 25mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: MSD International GmbH (Singapore Branch), Singapore City, Singapore
MSD International GmbH, t/a MSD Ireland (Carlow), Carlow, Ireland
   
Product: Savacol Freshmint Antiseptic Mouth & Throat Rinse
Active Ingredient: Chlorhexidine gluconate 1.26mg/mL
Dosage Form: Mouthwash
New Zealand Sponsor: Colgate-Palmolive Limited (NZ)
Manufacturers: Pax Australia Pty Limited, Sydney, Australia
Thepenier Pharma & Cosmetics, Saint Langis Les Mortagne, France


Dated this 16th day of December 2024.

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