This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 22/11/2022

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Amyotrophic Lateral Sclerosis
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Sanofi Mature IP
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Sanofi Mature IP
54 rue La Boétie
75008 Paris

Product information

09/11/2022 Rilutek - EMEA/H/C/000109 - PSUSA/00002645/202112

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other nervous system drugs

Therapeutic indication

Rilutek is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).

Clinical trials have demonstrated that Rilutek extends survival for patients with ALS.

Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.

There is no evidence that Rilutek exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms.

Rilutek has not been shown to be effective in the late stages of ALS.

Safety and efficacy of Rilutek has only been studied in ALS. Therefore, Rilutek should not be used in patients with any other form of motor-neurone disease.

Assessment history

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