Rilutek (riluzole)
- Region
- 🇪🇺 EU
- Active substance
- riluzole
- Company
- Sanofi Winthrop Industrie
- Status
- Authorised
- Therapeutic area
- Amyotrophic Lateral Sclerosis
- CHMP opinion
- Wed 14 Feb 1996
- EU approval
- Mon 10 Jun 1996
- Application
- EMEA/H/C/000109
- ATC
- N07XX02
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Dazluma Application withdrawn · Biohaven Bioscience Ireland Limited
- 🇪🇺 Riluzole Zentiva Authorised · Zentiva k.s.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.