Notice Type
Departmental
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:

Schedule

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Rilutek
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%.

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

Dated this 5th day of May 2017.

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