欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Rilutek
适用类别Human
治疗领域Amyotrophic Lateral Sclerosis
通用名/非专利名称riluzole
活性成分Riluzole
产品号EMEA/H/C/000109
患者安全信息No
许可状态Authorised
ATC编码N07XX02
是否额外监管No
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期1996/06/10
上市许可开发者/申请人/持有人Sanofi Winthrop Industrie
人用药物治疗学分组Other nervous system drugs
兽用药物治疗学分组
审评意见日期1996/02/14
欧盟委员会决定日期2024/07/24
修订号34
治疗适应症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.
适用物种
兽用药物ATC编码
首次发布日期2017/11/13
最后更新日期2024/08/21
产品说明书https://www.ema.europa.eu/en/documents/product-information/rilutek-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/rilutek
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