| 商品名称 | Levetiracetam ratiopharm |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Epilepsy |
| 通用名/非专利名称 | levetiracetam |
| 活性成分 | levetiracetam |
| 产品号 | EMEA/H/C/002244 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | N03AX14 |
| 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 | 2011/08/26 |
| 上市许可开发者/申请人/持有人 | ratiopharm GmbH |
| 人用药物治疗学分组 | Antiepileptics |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2025/06/26 |
| 修订号 | 16 |
| 治疗适应症 | Levetiracetam ratiopharm is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam ratiopharm is indicated as adjunctive therapy: in the treatment of partial onset seizures with or without secondary generalisation in adults, children and infants from 1 month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/08/10 |
| 最后更新日期 | 2025/06/30 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/levetiracetam-ratiopharm-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/levetiracetam-ratiopharm |