Riluzole Zentiva



This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 22/11/2022

Authorisation details

Product details
Riluzole Zentiva
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
Zentiva k.s.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

U kabelovny 130
102 37 Prague 10
Czech Republic

Product information

15/11/2022 Riluzole Zentiva - EMEA/H/C/002622 - 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

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. 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.

Assessment history

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