法规知识库 · EMA 集中审评
Levetiracetam ratiopharm
levetiracetam · EMEA/H/C/002244 · 已授权
获批上市许可
2011-08-26
欧委会决定日
2026-01-22
持有人 / 申请人
ratiopharm GmbH
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：Antiepileptics
修订号：17 · 最新影响 PI 的程序：VR/0000308189
适应症（原文）：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.
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。
2026-01-22 · 欧委会决定
2011-08-26 · 获批上市许可
说明书、EPAR 与其他文件
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EPAR / 审评资料
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Levetiracetam ratiopharm : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-01-26
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Levetiracetam ratiopharm : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-06-30
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Levetiracetam ratiopharm : EPAR - Summary for the public
overview · 2021-09-03
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Levetiracetam ratiopharm : EPAR - Public assessment report
assessment-report · 2011-09-19 · EMA/CHMP/318321/2011
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。