| 商品名称 | Lacosamide Adroiq |
|---|---|
| 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/006047 |
| 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 | 2023/05/31 |
| 上市许可开发者/申请人/持有人 | Extrovis EU Ltd |
| 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 | 2023/03/30 |
| 欧盟委员会决定日期 | 2025/09/23 |
| 修订号 | 6 |
| 治疗适应症 | Lacosamide Adroiq is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. Lacosamide Adroiq is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 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 | 2023/03/27 |
| 最后更新日期 | 2025/09/25 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/lacosamide-adroiq-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/lacosamide-adroiq |