Riluzole Zentiva

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riluzole

Authorised
This medicine is authorised for use in the European Union.

Overview

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 14/01/2019

Authorisation details

Product details
Name
Riluzole Zentiva
Agency product number
EMEA/H/C/002622
Active substance
Riluzole
International non-proprietary name (INN) or common name
riluzole
Therapeutic area (MeSH)
Amyotrophic Lateral Sclerosis
Anatomical therapeutic chemical (ATC) code
N07XX02
Publication details
Marketing-authorisation holder
Zentiva k.s.
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
07/05/2012
Contact address

U kabelovny 130
102 37 Prague 10
Czech Republic

Product information

18/09/2018 Riluzole Zentiva - EMEA/H/C/002622 - N/0024

Contents

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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 (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.

Assessment history

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