| 商品名称 | Diacomit |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Myoclonic Epilepsy, Juvenile |
| 通用名/非专利名称 | stiripentol |
| 活性成分 | stiripentol |
| 产品号 | EMEA/H/C/000664 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | N03AX17 |
| 是否额外监管 | no |
| 是否仿制药 | 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 |
| 批准上市日期 | 2007/01/03 |
| 拒绝批准上市日期 | 2009/02/11 |
| 上市许可持有人/公司名称 | Biocodex |
| 人用药物治疗分组 | Antiepileptics, |
| 决定日期 | 2023/04/25 |
| 修订号 | 18 |
| 适应症 | Diacomit is indicated for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet's syndrome) whose seizures are not adequately controlled with clobazam and valproate. |
| 首次发布日期 | 2014/06/23 |
| 修订日期 | 2023/08/25 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/diacomit-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/diacomit |