法规知识库 · EMA 集中审评
Levetiracetam Sun
levetiracetam · EMEA/H/C/002051 · 已授权
获批上市许可
2011-12-14
欧委会决定日
2025-12-22
持有人 / 申请人
Sun Pharmaceutical Industries Europe B.V.
终止日期字段
无
从产品到官方文件
文件记录
6
官方索引 6
EPAR / 审评
4
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：Other antiepileptics
修订号：22 · 最新影响 PI 的程序：VR/0000317912
适应症（原文）：Levetiracetam Sun 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 Sun is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults and children from four years 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. Levetiracetam Sun concentrate is an alternative for patients when oral administration is temporarily not feasible.
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。
2025-12-22 · 欧委会决定
2011-12-14 · 获批上市许可
2011-10-20 · 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 Sun : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-01-05
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Levetiracetam Sun : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2023-09-22
- 打开官方文件 ↗
Levetiracetam Sun : EPAR - Summary for the public
overview · 2021-09-03 · EMA/884002/2011
- 打开官方文件 ↗
Levetiracetam Sun : EPAR - Public assessment report
assessment-report · 2012-01-17 · EMA/CHMP/657653/2011
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。