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法规知识库 · EMA 集中审评

Levetiracetam Hospira

levetiracetam · EMEA/H/C/002783 · 已授权

仿制药

获批上市许可

2014-01-07

欧委会决定日

2025-12-12

持有人 / 申请人

Pfizer Europe MA EEIG

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

4

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:28 · 最新影响 PI 的程序:VR/0000315806

适应症(原文):Levetiracetam Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam Hospira is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 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 Hospira 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。

  1. 2025-12-12 · 欧委会决定

  2. 2014-01-07 · 获批上市许可

  3. 2013-10-23 · 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 4产品信息 3其他 0

EPAR / 审评资料

  • Levetiracetam Hospira : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2025-12-15

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  • Levetiracetam Hospira : EPAR - Procedural steps taken and scientific information after authorisation (archive)

    procedural-steps-after · 2025-05-12

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  • Levetiracetam Hospira : EPAR - Medicine overview

    overview · 2021-09-22

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  • Levetiracetam Hospira : EPAR - Public assessment report

    assessment-report · 2014-01-20 · EMA/777160/2013

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产品信息

  • Levetiracetam Hospira : EPAR - Product Information

    product-information · 2025-12-15

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  • Levetiracetam Hospira : EPAR - Product information - tracked changes

    product-information-tracked-changes · 2025-09-17

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  • Levetiracetam Hospira : EPAR - All Authorised presentations

    all-authorised-presentations · 2014-04-29

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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。