| Product No | EMEA/H/C/002622 |
|---|---|
| Brand Name | Riluzole Zentiva |
| Nonproprietary Name | riluzole |
| API | Riluzole |
| ATC Code | N07XX02 |
| Indications | 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. |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | Zentiva k.s. |
| Status | Authorised(授权) |
| Authorization Date | 2012-05-07 |
| Version | 13 |
| Condition Approval | no |
| Exceptions | no |
| Biosimilar | no |
| Details | 查看 (公众评估报告、授权细节、产品规格/剂型、标签、历史评估信息) |
Extended Information