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:||Riluzole 50mg|
|Dosage Form:||Film coated 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 Tablets can only be prescribed by authorised prescribers where the prescribing decision is taken in collaboration with, or following consultation with, physicians who care for patients with Motor Neuron 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 two years from 11 November 2021.
Dated this 10th day of November 2021.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).