法规知识库 · EMA 集中审评
Humira
adalimumab · EMEA/H/C/000481 · 已授权
获批上市许可
2003-09-08
欧委会决定日
2025-10-08
持有人 / 申请人
AbbVie Deutschland GmbH & Co. KG
终止日期字段
无
从产品到官方文件
文件记录
69
官方索引 69
EPAR / 审评
66
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：L04AB04
治疗领域：Spondylitis, Ankylosing;Arthritis, Juvenile Rheumatoid;Uveitis;Colitis, Ulcerative;Psoriasis;Arthritis, Psoriatic;Crohn Disease;Arthritis, Rheumatoid
药理分类：Immunosuppressants
修订号：99 · 最新影响 PI 的程序：EMA/VR/0000287800
适应症（原文）：Please refer to the product information document.
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。
2025-10-08 · 欧委会决定
2003-09-08 · 获批上市许可
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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Humira : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-14
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Humira : EPAR - Risk management plan
rmp · 2026-10-14
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Humira-PAM-000481-P46-01388-1 : EPAR - Assessment report
variation-report · 2025-08-13 · EMADOC-1700519818-2137325
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Humira-PAM-0000257452-P46-0120701 : EPAR - Assessment report
variation-report · 2025-06-13 · EMADOC-1700519818-1965497
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Humira : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-03-20
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Humira-H-C-000481-P46-125 : EPAR - Assessment Report
variation-report · 2022-08-02 · EMA/591638/2022
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Humira-H-C-481-P46-122 : EPAR - Assessment Report
variation-report · 2022-07-18 · EMA/CHMP/396886/2021
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Humira-H-C-481-P46-122 : EPAR - Assessment Report
variation-report · 2021-07-13 · EMA/CHMP/396886/2021
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Humira-H-C-481-P46-121 : EPAR - Assessment Report
variation-report · 2021-01-04 · EMA/637884/2020
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Humira-H-C-481-II-0198 : EPAR - Assessment Report - Variation
variation-report · 2020-12-09 · EMA/584443/2020
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Humira : EPAR - Medicine overview
overview · 2020-12-09 · EMA/670962/2020
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Humira-H-C-481-P46-0117 : EPAR - Assessment Report
variation-report · 2020-09-23 · EMA/280488/2020
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Humira-H-C-481-P46-0119 : EPAR - Assessment Report
variation-report · 2020-09-22 · EMA/495296/2020
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Humira-H-C-481-P46-0100 : EPAR - Assessment Report
variation-report · 2020-05-04 · EMA/160077/2020
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Humira-H-C-481-P46-0113 : EPAR - Assessment Report
variation-report · 2019-03-14 · EMA/132518/2019
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Humira-H-C-481-P46-112 : EPAR - Assessment Report
variation-report · 2019-03-06 · EMA/145491/2019
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Humira-H-C-481-P46-110 : EPAR - Assessment Report
variation-report · 2019-02-22 · EMA/907573/2019
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Humira-H-C-481-P46-103 : EPAR - Assessment Report
variation-report · 2019-01-14 · EMA/CHMP/428944/2018
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Humira-H-C-481-P46-104 : EPAR - Assessment Report
variation-report · 2019-01-14 · EMA/CHMP/501355/2018
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Humira-H-C-481-P46-107 : EPAR - Assessment Report
variation-report · 2019-01-14 · EMA/CHMP/551260/2018
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Humira-H-C-481-P46-108 : EPAR - Assessment Report
variation-report · 2019-01-14 · EMA/CHMP/777619/2018
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Humira-H-C-481-P46-102 : EPAR - Assessment Report
variation-report · 2018-05-03 · EMA/CHMP/222491/2018
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Humira-H-C-481-X-164/G : EPAR - Assessment Report - Variation
variation-report · 2017-12-15 · EMA/CHMP/829007/2017
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Humira-H-C-PSUSA-00000057-201612 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-12-15 · EMA/739440/2017
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Humira-H-C-481-II-0163 : EPAR - Assessment Report - Variation
variation-report · 2017-10-05 · EMA/CHMP/505087/2017
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Humira-H-C-481-II-0159 : EPAR - Assessment Report
variation-report · 2017-09-01 · EMA/CHMP/356790/2017
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Humira-H-C-481-P46-0099 : EPAR - Assessment Report
variation-report · 2017-03-15 · EMA/174639/2017
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Humira-H-C-481-P46-0096 : EPAR - Assessment Report
variation-report · 2017-03-15 · EMA/178260/2017
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Humira-H-C-481-P46-0098 : EPAR - Assessment Report
variation-report · 2017-03-15 · EMA/174447/2017
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Humira-H-C-481-II-0158 : EPAR - Assessment Report - Variation
variation-report · 2017-02-23 · EMA/130014/2017
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Humira : EPAR - Paediatric investigation plan compliance statement
pip-compliance · 2017-02-23 · EMA/126130/2017
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Humira-H-C-481-II-0154 : EPAR - Assessment Report - Variation
variation-report · 2017-02-21 · EMA/CHMP/676652/2016
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Humira : EPAR - Paediatric investigation plan compliance statement
pip-compliance · 2017-02-21 · EMA/691442/2016
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Humira-H-C-481-II-0146 : EPAR - Assessment Report - Variation
variation-report · 2017-02-08 · EMA/501143/2016
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Humira-H-C-481-P46-0093 : EPAR - Assessment Report
variation-report · 2017-01-31 · EMA/CHMP/65037/2017
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Humira-H-C-481-P46-0095 : EPAR - Assessment Report
variation-report · 2016-10-26 · EMA/621044/2016
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Humira-H-C-481-P46-0094 : EPAR - Assessment Report
variation-report · 2016-10-03 · EMA/645130/2016
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Humira-H-C-481-II-0147 : EPAR - Assessment Report - Variation
variation-report · 2016-07-18 · EMA/374316/2016
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Humira-H-C-481-P46-0091 : EPAR - Assessment Report
variation-report · 2016-06-16 · EMA/645500/2016
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Humira : EPAR - Paediatric investigation plan compliance statement
pip-compliance · 2016-05-25 · EMA/233471/2016
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Humira-H-C-481-II-0149 : EPAR - Assessment Report - Variation
variation-report · 2016-04-26 · EMA/281673/2016
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Humira-H-C-481-P46-0088 : EPAR - Assessment Report
variation-report · 2015-11-10 · EMA/743698/2015
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Humira-H-C-481-P46-0087 : EPAR - Assessment Report
variation-report · 2015-10-15 · EMA/684090/2015
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Humira-H-C-481-II-0137 : EPAR - Assessment report - Variation
variation-report · 2015-10-09 · EMA/CHMP/364731/2015
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Humira : EPAR - Paediatric investigation plan compliance statement
pip-compliance · 2015-05-12 · EMA/261748/2015
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Humira-H-C-481-II-0134 : EPAR - Assessment Report - Extension
variation-report · 2015-05-12 · EMA/CHMP/177541/2015
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Humira-H-C-481-PSUV-0131 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-12-18 · EMA/CHMP/772726/2014
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Humira-H-C-481-II-00127 : EPAR - Assessment Report - Variation
variation-report · 2014-10-14 · EMA/562197/2014
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Humira-H-C-481-II-0125 : EPAR - Assessment Report - Variation
variation-report · 2014-08-04 · EMA/CHMP/758439/2013
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Humira-H-C-481-II-0102 : EPAR - Assessment Report - Variation
variation-report · 2013-04-15 · EMA/76107/2013
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Humira-H-C-481-II-0082 : EPAR - Assessment Report - Variation
variation-report · 2013-03-06 · EMA/217675/2012
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Humira-H-C-481-II-0088 : EPAR - Assessment Report - Variation
variation-report · 2013-02-04 · EMA/56352/2013
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Humira-H-C-481-P46-0076 : EPAR - Assessment Report
variation-report · 2012-12-14 · EMA/784100/2012
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Humira-H-C-481-II-0094: EPAR - Assessment Report - Variation
variation-report · 2012-09-26 · EMA/CHMP/609117/2012
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Humira-H-C-481-II-0085 : EPAR - Assessment Report - Variation
variation-report · 2012-09-11 · EMA/CHMP/220041/2012
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Humira-H-C-481-II-0081-G : EPAR - Assessment Report - Variation
variation-report · 2011-05-19 · EMA/227628/2011
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Humira-H-C-481-II-39 : EPAR - Assessment Report - Variation
variation-report · 2008-10-02
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Humira-H-C-481-II-43 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2008-02-19
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Humira-H-C-481-II-38 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2008-02-05
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Humira-H-C-481-II-33 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2007-07-02
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Humira-H-C-481-II-26 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2006-07-31
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Humira : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-03-30
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Humira-H-C-481-II-06 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2006-03-30
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Humira-H-C-481-II-21 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2006-03-30
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Humira : EPAR - Scientific Discussion
scientific-discussion · 2006-03-30
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Humira-H-C-481-II-22 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2006-03-30
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。