Rilutek

riluzole

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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).

What is Rilutek?

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

What is Rilutek used for?

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.

How is Rilutek used?

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.

How does Rilutek work?

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.

How has Rilutek been studied?

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.

What benefit has Rilutek shown during the studies?

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.

What is the risk associated with Rilutek?

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.

Why has Rilutek been approved?

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

Other information about Rilutek

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.

 

Name Language First published Last updated
Rilutek : EPAR - Summary for the public BG = bălgarski 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public ES = español 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public CS = čeština 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public DA = dansk 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public DE = Deutsch 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public ET = eesti keel 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public EL = elliniká 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public EN = English 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public FR = français 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public IT = italiano 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public LV = latviešu valoda 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public LT = lietuvių kalba 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public HU = magyar 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public MT = Malti 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public NL = Nederlands 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public PL = polski 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public PT = português 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public RO = română 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public SK = slovenčina 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public SL = slovenščina 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public FI = suomi 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public SV = svenska 16/04/2007 24/05/2016
Rilutek : EPAR - Summary for the public HR = Hrvatski 16/04/2007 24/05/2016

This EPAR was last updated on 24/05/2016 .

Authorisation details

Product details

Product details for Rilutek
NameRilutek
Agency product numberEMEA/H/C/000109
Active substance

riluzole

International non-proprietary name (INN) or common name

riluzole

Therapeutic area Amyotrophic Lateral Sclerosis
Anatomical therapeutic chemical (ATC) code N07XX02

Publication details

Publication details for Rilutek
Marketing-authorisation holder

Aventis Pharma S.A.

Revision24
Date of issue of marketing authorisation valid throughout the European Union10/06/1996

Contact address:

Aventis Pharma S.A.
20 avenue Raymond Aron
92165 Antony Cedex
France

Product information

Product information

31/03/2016  Rilutek -EMEA/H/C/000109 -N/0056

Name Language First published Last updated
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016
Rilutek : EPAR - Product Information HR = Hrvatski 25/08/2009 14/04/2016

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.


Name Language First published Last updated
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010
Rilutek : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 24/11/2010

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Rilutek : EPAR - Procedural steps taken before authorisation HR = Hrvatski 21/10/2005  
Rilutek : EPAR - Scientific Discussion HR = Hrvatski 21/10/2005  

Authorised

This medicine is approved for use in the European Union