Notice Title

Consent to the Distribution of New Medicines

Publication Date
30 Mar 2023

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2023-go1288
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: Evrysdi
Active Ingredient: Risdiplam 0.75mg/mL
Dosage Form: Powder for oral solution
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: F Hoffmann-La Roche Limited, Basel, Switzerland
   
Product: Pimafucort
Active Ingredients: Hydrocortisone 1%
Natamycin 1%
Neomycin sulfate 0.35%
Dosage Form: Topical ointment
New Zealand Sponsor: LEO Pharma Limited
Manufacturers: Astellas Pharma Europe B.V., Meppel, Netherlands
Temmler Italia S.r.l., Carugate, Italy


Dated this 29th day of March 2023.

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