| Product No | EMEA/H/C/000109 |
|---|---|
| Brand Name | Rilutek |
| Nonproprietary Name | riluzole |
| API | Riluzole |
| ATC Code | N07XX02 |
| Indications | 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. |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | Sanofi Mature IP |
| Status | Authorised(授权) |
| Authorization Date | 1996-06-10 |
| Version | 31 |
| 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