Notice Title

Consent to the Distribution of a New Medicine

Publication Date
26 Jun 2020

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2020-go2823
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 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: Xgeva
Active Ingredient: Denosumab 120mg
Dosage Form: Solution for injection
New Zealand Sponsor: Amgen New Zealand Limited
Manufacturers: Amgen Manufacturing Limited, Juncos, Puerto Rico
Amgen Technology (Ireland) Unlimited Company, Dun Laoghaire, Ireland


Dated this 25th day of June 2020.

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