🇪🇺 Riluzole (100 mg) in European Union

EMA authorised Riluzole (100 mg) on 10 June 1996

Marketing authorisation

EMA — authorised 10 June 1996

  • Application: EMEA/H/C/000109
  • Marketing authorisation holder: Sanofi Winthrop Industrie
  • Local brand name: Rilutek
  • 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 i
  • Status: approved

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Riluzole (100 mg) in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Neurology approved in European Union

Frequently asked questions

Is Riluzole (100 mg) approved in European Union?

Yes. EMA authorised it on 10 June 1996.

Who is the marketing authorisation holder for Riluzole (100 mg) in European Union?

Sanofi Winthrop Industrie holds the EU marketing authorisation.