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: Rilutek
Active Ingredient: Riluzole 50mg
Dosage Form: Tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Winthrop Industrie, Compiegne, France
Note: This consent is given subject to the following conditions:
Rilutek can only be prescribed by specialist physicians who care for patients with Motor Neurone Disease, neurologists and palliative care physicians.
Note: This consent is valid for two years from the date of publication of this notice.
Dated this 28th day of March 2013.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).