Notice Title

Consent to the Distribution of New Medicines

Publication Date
18 Aug 2022

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2022-go3463
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 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: Kanjinti
Active Ingredient: Trastuzumab 60mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Amgen New Zealand Limited
Manufacturer: Actavis Italy S.p.A, Nerviano, Italy
   
Product: Kanjinti
Active Ingredient: Trastuzumab 150mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Amgen New Zealand Limited
Manufacturers: Actavis Italy S.p.A, Nerviano, Italy
Amgen Technology (Ireland) Unlimited Company, Dun Laoghaire, Ireland
   
Product: Kanjinti
Active Ingredient: Trastuzumab 440mg
Dosage Form: Powder for infusion concentrate
New Zealand Sponsor: Amgen New Zealand Limited
Manufacturers: Actavis Italy S.p.A, Nerviano, Italy
Amgen Technology (Ireland) Unlimited Company, Dun Laoghaire, Ireland


Dated this 15th day of August 2022.

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