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).

Rilutek is a medicine containing the active substance riluzole. It is available as 50 mg tablets.

Rilutek is used in patients with amyotrophic lateral sclerosis (ALS). ALS is a form of motor neuron disease where the nerve cells responsible for sending instructions to the muscles gradually deteriorate, leading to weakness, muscle wasting and paralysis. Rilutek is used to extend the patient’s life or to delay the need for mechanical ventilation.

Rilutek should not be used in patients with any other form of motor neuron disease.

The medicine can only be obtained with a prescription.

Treatment with Rilutek should only be started by a specialist doctor with experience in the management of motor neuron diseases. The recommended dose is 100 mg per day (given as one 50 mg tablet every 12 hours). For more information, see the package leaflet.

The active substance in Rilutek, riluzole, acts on the nervous system. The exact way in which it works in ALS is not known. It is thought that the destruction of nerve cells in motor neuron disease may be caused by too much of the neurotransmitter glutamate. Neurotransmitters are substances that nerve cells use to communicate with neighbouring cells. Riluzole stops the release of glutamate and this may help in preventing the nerve cells being damaged.

three studies involving a total of 1,282 patients. One of these studies was in older patients (over 75) and in patients with advanced disease. Across the studies, Rilutek was given as 50, 100 or 200 mg per day, and for up to 18 months. The main measure of effectiveness was the average survival time.

The average survival time was significantly longer for patients who received Rilutek compared with patients who received placebo. Looking at the results of the three studies together, over 18 months, patients who received Rilutek 100 mg/day had an average survival time that was about 2 months longer than the survival time for patients who received placebo. Rilutek 50 mg/day was no more effective than placebo and 200 mg/day was no more effective than 100 mg/day. The medicine was not more effective than placebo in the late stages of ALS.

The most common side effects seen with Rilutek (in more than 1 patient in 10) are nausea (feeling sick), asthenia (weakness) and abnormal liver tests. For the full list of all side effects reported with Rilutek, see the package leaflet.

Rilutek must not be used in patients who have liver disease or who have abnormally high levels of liver enzymes. Rilutek must also not be given to women who are pregnant or breastfeeding. For the full list of restrictions, see the package leaflet.

The CHMP decided that Rilutek’s benefits are greater than its risks and recommended that it be given marketing authorisation.

The European Commission granted a marketing authorisation valid throughout the European Union for Rilutek.

For more information about treatment with Rilutek, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Rilutek : EPAR - Summary for the public

български (BG) (99.02 KB - PDF)
español (ES) (72.83 KB - PDF)
čeština (CS) (96.55 KB - PDF)
dansk (DA) (72.22 KB - PDF)
Deutsch (DE) (74.34 KB - PDF)
eesti keel (ET) (71.62 KB - PDF)
ελληνικά (EL) (100.65 KB - PDF)
français (FR) (73.44 KB - PDF)
hrvatski (HR) (89.8 KB - PDF)
italiano (IT) (72.66 KB - PDF)
latviešu valoda (LV) (93.86 KB - PDF)
lietuvių kalba (LT) (93.53 KB - PDF)
magyar (HU) (92.02 KB - PDF)
Malti (MT) (97.69 KB - PDF)
Nederlands (NL) (72.61 KB - PDF)
polski (PL) (97.41 KB - PDF)
português (PT) (72.96 KB - PDF)
română (RO) (93.55 KB - PDF)
slovenčina (SK) (96.92 KB - PDF)
slovenščina (SL) (88.88 KB - PDF)
Suomi (FI) (71.67 KB - PDF)
svenska (SV) (72.38 KB - PDF)

Product information

Rilutek : EPAR - Product Information

български (BG) (401.57 KB - PDF)
español (ES) (309.28 KB - PDF)
čeština (CS) (353.61 KB - PDF)
dansk (DA) (318.66 KB - PDF)
Deutsch (DE) (341.37 KB - PDF)
eesti keel (ET) (310.97 KB - PDF)
ελληνικά (EL) (397.72 KB - PDF)
français (FR) (367.16 KB - PDF)
hrvatski (HR) (316.98 KB - PDF)
íslenska (IS) (333.26 KB - PDF)
italiano (IT) (305.28 KB - PDF)
latviešu valoda (LV) (340.3 KB - PDF)
lietuvių kalba (LT) (337.42 KB - PDF)
magyar (HU) (379.09 KB - PDF)
Malti (MT) (377.12 KB - PDF)
Nederlands (NL) (299.3 KB - PDF)
norsk (NO) (318.58 KB - PDF)
polski (PL) (386.34 KB - PDF)
português (PT) (315.24 KB - PDF)
română (RO) (347.02 KB - PDF)
slovenčina (SK) (375.9 KB - PDF)
slovenščina (SL) (349.32 KB - PDF)
Suomi (FI) (310.04 KB - PDF)
svenska (SV) (317.98 KB - PDF)

Latest procedure affecting product information: N/0073

12/01/2024

Globe icon

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

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).

Rilutek : EPAR - All Authorised presentations

български (BG) (81.34 KB - PDF)
español (ES) (79.94 KB - PDF)
čeština (CS) (94.53 KB - PDF)
dansk (DA) (67.09 KB - PDF)
Deutsch (DE) (74.49 KB - PDF)
eesti keel (ET) (80.73 KB - PDF)
ελληνικά (EL) (80.69 KB - PDF)
français (FR) (79.4 KB - PDF)
hrvatski (HR) (80.02 KB - PDF)
íslenska (IS) (79.76 KB - PDF)
italiano (IT) (76.65 KB - PDF)
latviešu valoda (LV) (66.11 KB - PDF)
lietuvių kalba (LT) (81.81 KB - PDF)
magyar (HU) (79.75 KB - PDF)
Malti (MT) (87.47 KB - PDF)
Nederlands (NL) (66.51 KB - PDF)
norsk (NO) (80.37 KB - PDF)
polski (PL) (74.07 KB - PDF)
português (PT) (78.13 KB - PDF)
română (RO) (85.84 KB - PDF)
slovenčina (SK) (81.44 KB - PDF)
slovenščina (SL) (82.17 KB - PDF)
Suomi (FI) (75.8 KB - PDF)
svenska (SV) (79.68 KB - PDF)

Product details

Name of medicine
Rilutek
Active substance
Riluzole
International non-proprietary name (INN) or common name
riluzole
Therapeutic area (MeSH)
Amyotrophic Lateral Sclerosis
Anatomical therapeutic chemical (ATC) code
N07XX02

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.

Authorisation details

EMA product number
EMEA/H/C/000109
Marketing authorisation holder
Sanofi Winthrop Industrie

82 Avenue Raspail
94250 Gentilly
FRANCE

Opinion adopted
14/02/1996
Marketing authorisation issued
10/06/1996
Revision
33

Assessment history

Rilutek : EPAR - Procedural steps taken and scientific information after authorisation

Rilutek-H-C-PSUSA-00002645-202112 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Rilutek : EPAR - Steps taken after authorisation when a cutoff date has been used

Rilutek : EPAR - Scientific Discussion

Rilutek : EPAR - Procedural steps taken before authorisation

Topics

This page was last updated on

How useful do you find this page?