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Riluzole Zentiva (riluzole)

Region

🇪🇺 EU

Active substance

riluzole

Company

Zentiva k.s.

Status

Authorised

Therapeutic area

Amyotrophic Lateral Sclerosis

EU approval

Mon 07 May 2012

Application

EMEA/H/C/002622

ATC

N07XX02

Official record

www.ema.europa.eu

Indication

Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). Clinical trials have demonstrated that Riluzole Zentiva 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 Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Riluzole Zentiva has not been shown to be effective in the late stages of ALS. Safety and efficacy of Riluzole Zentiva has only been studied in ALS. Therefore, Riluzole Zentiva 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• 🇪🇺 Dazluma Application withdrawn · Biohaven Bioscience Ireland Limited
• 🇪🇺 Rilutek Authorised · Sanofi Winthrop Industrie

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.