Notice Type
Notice Title

Renewal of Provisional Consent to the Distribution of a Medicine

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:


Active Ingredient:
Dosage Form:
New Zealand Sponsor:

Riluzole 50mg
Film coated tablet
Sanofi-Aventis New Zealand Limited
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. Rilutek Tablets can only be used by patients with vital capacity greater than 60%.

Note: This renewed consent is valid for 6 months from 11 May 2019.

Dated this 3rd day of May 2019.

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