This is a summary of the European public assessment report (EPAR) for Riluzole Zentiva. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Riluzole Zentiva.
Riluzole Zentiva : EPAR - Summary for the public (PDF/66.54 KB)
First published: 23/05/2012
Last updated: 23/05/2012
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Amyotrophic Lateral Sclerosis
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
U kabelovny 130
09/09/2020 Riluzole Zentiva - EMEA/H/C/002622 - IA/0028
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
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Other nervous system drugs
Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).
Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS (see section 5.1). Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.
There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Riluzole Zentiva has not been shown to be effective in the late stages of ALS.
Safety and efficacy of Riluzole Zentiva has only been studied in ALS. Therefore, Riluzole Zentiva should not be used in patients with any other form of motor-neurone disease.