法规知识库 · EMA 集中审评
Keppra
levetiracetam · EMEA/H/C/000277 · 已授权
获批上市许可
2000-09-29
欧委会决定日
2026-04-01
持有人 / 申请人
UCB Pharma SA
终止日期字段
无
从产品到官方文件
文件记录
31
官方索引 31
EPAR / 审评
28
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：N03AX14
治疗领域：Epilepsy
药理分类：Antiepileptics
修订号：58 · 最新影响 PI 的程序：N/0000339920
适应症（原文）：Keppra 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. Keppra 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。
2026-04-01 · 欧委会决定
2000-09-29 · 获批上市许可
2000-06-29 · 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
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Keppra : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-04-01
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Keppra-PSUSA-00001846-202411 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2025-10-20 · EMADOC-1700519818-2544162
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Keppra : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-06-30
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Keppra : EPAR - Risk-management-plan summary
rmp-summary · 2025-01-06
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Keppra : EPAR - Summary for the public
overview · 2021-06-02
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Keppra-H-C-277-P46-0085 : EPAR - Assessment Report
variation-report · 2017-01-06 · EMA/CHMP/769369/2016
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Keppra-H-C-PSUSA-1846-201511 : EPAR - Scientific Conclusion
scientific-conclusion · 2016-11-16 · EMA/677040/2016
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Keppra-H-C-P46-0083 : EPAR - Assessment Report
variation-report · 2016-08-03 · EMA/489130/2016
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Keppra-H-C-606-P46-0051 : EPAR - Assessment Report
variation-report · 2016-03-23 · EMA/CHMP/89384/2016
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Keppra-H-C-277-P46-0079 : EPAR - Assessment Report
variation-report · 2016-03-17 · EMA/859605/2015
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Keppra-H-C-277-P46-0080: EPAR - Assessment Report
variation-report · 2016-02-16 · EMA/CHMP/133443/2016
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Keppra-H-C-277-P46-0078 : EPAR - Assessment report
variation-report · 2015-07-30 · EMA/348791/2015
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Keppra-H-C-277-P46-0077: EPAR - Assessment report
variation-report · 2015-06-05 · EMA/CHMP/382391/2015
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Keppra-H-C-277-P46-0072-0075 : EPAR - Scientific Discussion
scientific-discussion-variation · 2014-08-01 · EMA/408255/2014
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Keppra-H-C-277-PSUV-0140 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2013-10-03 · EMA/573970/2013
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Keppra-H-C-277-P46-0060 : EPAR - Assessment Report
variation-report · 2013-04-05 · EMA/163052/2013
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Keppra-H-C-277-P46-0062 : EPAR - Assessment Report
variation-report · 2013-04-05 · EMA/163062/2013
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Keppra-H-C-277-P46-0065 : EPAR - Assessment Report
variation-report · 2013-03-21 · EMA/163119/2013
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Keppra-H-C-277-P45-0052: EPAR - Assessment Report
variation-report · 2012-11-05 · EMA/639978/2012
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Keppra-H-C-277-II-0097 : EPAR - Assessment Report - Variation
variation-report · 2009-09-18
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Keppra-H-C-277-II-0071 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2007-02-13
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Keppra-H-C-277-X-0046 : EPAR - Scientific Discussion - Extension
scientific-discussion-variation · 2006-09-12
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Keppra-H-C-277-II-0061 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2006-09-12
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Keppra-H-C-277-II-0063 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2006-09-12
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Keppra-H-C-277-II-0044 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2005-12-09
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Keppra : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2005-10-21
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Keppra : EPAR - Scientific Discussion
scientific-discussion · 2005-10-21
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Keppra : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2005-10-21
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。