Riluzole - EPARs for authorised medicinal products for human use - Rilutek

FICHA FARMACOLÓGICA de Riluzole . Contiene la Monografía en distintos idiomas (de la Unión Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. MAYO 27, 2010.-

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EPARs for authorised medicinal products for human use - Rilutek

Active Substance
Riluzole
International Nonproprietary Name or Common Name
Riluzole
Pharmaco-therapeutic Group
Other Nervous System Drugs
ATC Code
N07X X02

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 any other form of motor neurone disease.

Date of issue of Marketing Authorisation valid throughout the European Union
10 June 1996

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use