| 商品名称 | Amifampridine SERB |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Lambert-Eaton Myasthenic Syndrome;Paraneoplastic Syndromes, Nervous System;Nervous System Neoplasms;Paraneoplastic Syndromes;Nervous System Diseases;Autoimmune Diseases of the Nervous System;Neurodegenerative Diseases;Neuromuscular Diseases;Neuromuscular Junction Diseases;Immune System Diseases;Autoimmune Diseases;Autoimmune Diseases of the Nervous System;Cancer;Neoplasms |
| 通用名/非专利名称 | amifampridine |
| 活性成分 | amifampridine phosphate |
| 产品号 | EMEA/H/C/005839 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | N07XX05 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | Yes |
| 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 | 2022/05/19 |
| 上市许可开发者/申请人/持有人 | SERB SA |
| 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 | 2022/03/24 |
| 欧盟委员会决定日期 | 2022/05/19 |
| 修订号 | |
| 治疗适应症 | Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2022/03/22 |
| 最后更新日期 | 2022/05/24 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/amifampridine-serb-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/amifampridine-serb |