Rilutek

RSS

riluzole

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

Overview

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 23/01/2018

Authorisation details

Product details
Name
Rilutek
Agency product number
EMEA/H/C/000109
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
Aventis Pharma S.A.
Revision
25
Date of issue of marketing authorisation valid throughout the European Union
09/06/1996
Contact address
20 avenue Raymond Aron
92165 Antony Cedex
France

Product information

12/11/2017 Rilutek - EMEA/H/C/000109 - N/0057

Contents

  • 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.

You are therefore advised to be selective about which sections or pages you wish to print.

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

How useful was this page?

Add your rating