Notice Title

Consent to the Distribution of New Medicines

Publication Date
7 Oct 2021

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2021-go4310
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 set out in the Schedule hereto:

Schedule

Product: Xofluza
Active Ingredient: Baloxavir marboxil 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Shionogi Pharma Co. Limited, Settsu, Japan
   
Product: Xofluza
Active Ingredient: Baloxavir marboxil 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Shionogi Pharma Co. Limited, Settsu, Japan


Dated this 4th day of October 2021.

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