欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Riluzole Zentiva
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/002622
患者安全信息No
许可状态Authorised
ATC编码N07XX02
是否额外监管Nei
是否仿制药或hybrid药物Nei
是否生物类似药Nei
是否附条件批准Nei
是否特殊情形Nei
是否加速审评Nei
是否罕用药Nei
上市许可日期2012/05/07
上市许可开发者/申请人/持有人Zentiva k.s.
人用药物治疗学分组Other nervous system drugs
兽用药物治疗学分组
欧盟委员会决定日期2025/05/15
修订号14
治疗适应症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.
适用物种
兽用药物ATC编码
首次发布日期2018/05/08
最后更新日期2025/05/15
产品说明书https://www.ema.europa.eu/en/documents/product-information/riluzole-zentiva-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/riluzole-zentiva
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