Notice Type
Notice Title

Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:


Product: Sabril
Active Ingredient: Vigabatrin 500mg
Dosage Form: Powder for oral solution
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Patheon France SA, Bourgoin Jallieu, France

This consent is given subject to the following condition:

The medicine may only be marketed or distributed when no other vigabatrin oral powder medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet PHARMAC supply obligations.

Note: This consent is valid for two years from the date of publication of this notice.

Dated this 18th day of September 2023.

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