| 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; |
| 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 |
| 授权状态 | Authorised |
| ATC编码 | N07XX05 |
| 是否额外监管 | no |
| 是否仿制药 | 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 |
| 批准上市日期 | 2022/05/19 |
| 上市许可持有人/公司名称 | SERB SA |
| 人用药物治疗分组 | Other nervous system drugs |
| 审评意见发布日期 | 2022/03/24 |
| 修订号 | |
| 适应症 | Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. |
| 首次发布日期 | 2022/03/22 |
| 修订日期 | 2022/05/24 |
| 产品信息 | 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 |