法规知识库 · EMA 集中审评
Cimzia
certolizumab pegol · EMEA/H/C/000740 · 已拒绝
获批上市许可
未记录
欧委会决定日
2008-03-20
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
18
官方索引 18
EPAR / 审评
16
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AB05
治疗领域：Crohn Disease
药理分类：Immunosuppressants
修订号：— · 最新影响 PI 的程序：—
适应症（原文）：Cimzia, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARD) including methotrexate, has been inadequate.Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.Cimzia has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
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。
2008-05-21 · 拒绝上市许可
2008-03-20 · 欧委会决定
2008-03-19 · 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 ↗
Cimzia : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-09-04
- 打开官方文件 ↗
Cimzia-PAM-0000263734 : EPAR - Assessment report
variation-report · 2025-07-01 · EMADOC-1700519818-2036370
- 打开官方文件 ↗
Cimzia : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-04-29
- 打开官方文件 ↗
Cimzia-H-C-1037-P46-041 : EPAR - Assessment report
variation-report · 2025-02-18 · EMA/54239/2025
- 打开官方文件 ↗
Cimzia-H-C-1037-P46-040 : EPAR - Assessment Report
variation-report · 2024-08-22 · EMA/CHMP/330518/2024
- 打开官方文件 ↗
Cimzia : EPAR - Risk-management-plan summary
rmp-summary · 2021-07-08
- 打开官方文件 ↗
Cimzia : EPAR - Medicine overview
overview · 2019-07-24 · EMA/409425/2019
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Cimzia-H-C-1037-II-0065 : EPAR - Assessment Report - Variation
variation-report · 2018-09-20 · EMA/502221/2018
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Cimzia-H-C-1037-PSUSA-00000624-201703 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-02-06 · EMA/18703/2018
- 打开官方文件 ↗
Cimzia-H-C-1037-II-0045 : EPAR - Assessment Report - Variation
variation-report · 2016-02-11 · EMA/CHMP/825080/2015
- 打开官方文件 ↗
Cimzia-H-C-1037-PSUV-0041 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-01-19 · EMA/CHMP/33893/2015
- 打开官方文件 ↗
Cimzia-H-C-1037-II-0027 : EPAR - Assessment Report - Variation
variation-report · 2014-01-03 · EMA/CHMP/601513/2013
- 打开官方文件 ↗
Cimzia-H-C-1037-II-0029 : EPAR - Assessment Report - Variation
variation-report · 2013-11-07 · EMA/CHMP/458168/2013
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Cimzia : EPAR - Public assessment report
assessment-report · 2009-10-22
- 打开官方文件 ↗
Cimzia : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
conditions-member-states · 2009-10-01
- 打开官方文件 ↗
Cimzia : EPAR - Refusal public assessment report
assessment-report · 2008-05-23
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。