Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

Publication Date
11 Jul 2024

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2024-go3302

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: Epilim IV
Active Ingredient: Sodium valproate 400mg
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Sanofi SRL, Anagni, Italy
   
Product: Evrysdi
Active Ingredient: Risdiplam 0.75mg/mL
Dosage Form: Powder for oral solution
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
F Hoffmann-La Roche Limited, Kaiseraugst, Switzerland
   
Product: Flamazine (Pharmacy only)
Active Ingredient: Sulfadiazine silver 1%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Smith & Nephew Limited
Manufacturer: Recipharm Parets S.L.U., Barcelona, Spain
   
Product: Flamazine (Prescription)
Active Ingredient: Sulfadiazine silver 1%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Smith & Nephew Limited
Manufacturer: Recipharm Parets S.L.U., Barcelona, Spain


Dated this 9th day of July 2024.

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