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).
Rilutek : EPAR - Summary for the public (PDF/72.88 KB)
First published: 16/04/2007
Last updated: 24/05/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Amyotrophic Lateral Sclerosis
|Anatomical therapeutic chemical (ATC) code||
Sanofi Mature IP
|Date of issue of marketing authorisation valid throughout the European Union||
Sanofi Mature IP
09/11/2022 Rilutek - EMEA/H/C/000109 - PSUSA/00002645/202112
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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Other nervous system drugs
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.