| 商品名称 | Levetiracetam Actavis Group |
|---|---|
| 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/002305 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | N03AX14 |
| 是否额外监管 | Nei |
| 是否仿制药或hybrid药物 | Já |
| 是否生物类似药 | Nei |
| 是否附条件批准 | Nei |
| 是否特殊情形 | Nei |
| 是否加速审评 | Nei |
| 是否罕用药 | Nei |
| 上市许可日期 | 2011/12/04 |
| 上市许可开发者/申请人/持有人 | Actavis Group PTC ehf |
| 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 | 19 |
| 治疗适应症 | Levetiracetam Actavis Group 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 Actavis Group 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 | 2018/03/20 |
| 最后更新日期 | 2025/06/30 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/levetiracetam-actavis-group-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/levetiracetam-actavis-group |