Notice Title

Consent to the Distribution of a New Medicine

Publication Date
27 Aug 2020

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2020-go3881
Title
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File Type and Size
PDF (34 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 medicine which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out in the Schedule hereto:

Schedule

Product: Forxiga
Active Ingredient: Dapagliflozin propanediol monohydrate 12.3mg equivalent to dapaglifozin 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: Bristol-Myers Squibb Manufacturing Company, Humacao, Puerto Rico
AstraZeneca Pharmaceuticals LP, Indiana, United States of America


Dated this 21st day of August 2020.

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