法规知识库 · EMA 集中审评
Levetiracetam Accord
levetiracetam · EMEA/H/C/002290 · 已授权
获批上市许可
2011-10-03
欧委会决定日
2025-12-09
持有人 / 申请人
Accord Healthcare S.L.U.
终止日期字段
无
从产品到官方文件
文件记录
7
官方索引 7
EPAR / 审评
5
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：N03AX14
治疗领域：Epilepsy
药理分类：Antiepileptics
修订号：21 · 最新影响 PI 的程序：VR/0000316836
适应症（原文）：Levetiracetam 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 is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one 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.
关键日期时间轴
来自 EMA medicines JSON 日期字段；缺失字段不展示，不补推结论。
2025-12-09 · 欧委会决定
2011-10-03 · 获批上市许可
2011-07-21 · CHMP 意见通过
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url；本站不下载或镜像 PDF。
EPAR / 审评资料
- 打开官方文件 ↗
Levetiracetam Accord : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-12-09
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Levetiracetam Accord : EPAR - Risk management plan
rmp · 2025-07-11
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Levetiracetam Accord : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-01-09
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Levetiracetam Accord : EPAR - Summary for the public
overview · 2021-09-10 · EMA/683201/2011
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Levetiracetam Accord : EPAR - Public assessment report
assessment-report · 2011-10-14 · EMA767403/2011
数据来自 EMA 官方 JSON；最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。