| 商品名称 | Lacosamide Accord |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Epilepsy |
| 通用名/非专利名称 | lacosamide |
| 活性成分 | lacosamide |
| 产品号 | EMEA/H/C/004443 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | N03AX18 |
| 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 | 2017/09/18 |
| 上市许可开发者/申请人/持有人 | Accord Healthcare S.L.U. |
| 人用药物治疗学分组 | Antiepileptics |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2017/07/20 |
| 欧盟委员会决定日期 | 2025/05/28 |
| 修订号 | 13 |
| 治疗适应症 | Lacosamide Accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. Lacosamide Accord is indicated as adjunctive therapy • in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. • in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/04/04 |
| 最后更新日期 | 2025/05/28 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/lacosamide-accord-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/lacosamide-accord |