Notice Title

Consent to the Distribution of New Medicines

Publication Date
21 Nov 2024

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2024-go5898
Title
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File Type and Size
PDF (35 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: Trulicity
Active Ingredient: Dulaglutide 3mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturers: Eli Lilly and Company Inc, Indiana, United States of America
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Eli Lilly Italia SpA, Florence, Italy
   
Product: Xofluza
Active Ingredient: Baloxavir marboxil 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Shionogi Pharma Co. Limited, Osaka, Japan
   
Product: Xofluza
Active Ingredient: Baloxavir marboxil 40mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
Shionogi Pharma Co. Limited, Osaka, Japan


Dated this 15th day of November 2024.

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