法规知识库 · EMA 集中审评

Abilify

aripiprazole · EMEA/H/C/000471 · 已授权

获批上市许可

2004-06-04

欧委会决定日

2026-01-09

持有人 / 申请人

Otsuka Pharmaceutical Netherlands B.V.

终止日期字段

无

从产品到官方文件

文件记录

官方索引 27

EPAR / 审评

assessment / overview 等

产品信息

PI / presentations

其他

RMP / PIP 等

ATC：N05AX12

治疗领域：Schizophrenia;Bipolar Disorder

药理分类：Psycholeptics

修订号：50 · 最新影响 PI 的程序：VR/0000313289

适应症（原文）：Abilify is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Abilify is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Abilify is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.

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。

2026-01-09 · 欧委会决定
2004-06-04 · 获批上市许可
2004-02-26 · 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 23产品信息 4其他 0

EPAR / 审评资料

Abilify : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-01-12
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Abilify : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-01-12
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Abilify-H-C-PSUSA-00000234-201907 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-05-14 · EMA/261452/2020
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Abilify : EPAR - Risk-management-plan summary
rmp-summary · 2019-07-19
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Abilify : EPAR - Summary for the public
overview · 2017-01-27
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Abilify-H-C-471-II-0110 : EPAR - Assessment Report - Variation
variation-report · 2016-10-25 · EMA/702260/2016
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Abilify : EPAR - Assessment Report - Variation
variation-report · 2016-10-25 · EMA/702260/2016
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Abilify-H-C-PSUSA-00000234-201507 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2016-05-02 · EMA/270332/2016
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Abilify-H-C-PSUSA-00000234-201407 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-06-02 · EMA/CHMP/305112/2015
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Abilify-H-C-471-P46-0074 : EPAR - Assessment Report
variation-report · 2015-04-07 · EMA/CHMP/92268/2015
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Abilify-H-C-471-II-0101 : EPAR - Assessment Report - Variation
variation-report · 2014-10-02 · EMA/557557/2014
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Abilify-H-C-471-P46-0061 : EPAR - Assessment Report
variation-report · 2014-10-02 · EMA/558302/2014
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Abilify-H-C-471-II-0084 : EPAR - Assessment Report - Variation
variation-report · 2013-10-08 · EMA/488885/2013
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Abilify-H-C-471-P46-0065 : EPAR - Assessment Report
variation-report · 2013-10-08 · EMA/488884/2013
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Abilify-H-C-471-PSU-0063 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2013-10-08 · EMA/484705/2013
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Abilify-H-C-471-P46-0066 : EPAR - Assessment Report
variation-report · 2013-10-08 · EMA/540048/2013
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Abilify-H-C-471-II-0082 : EPAR - Assessment Report - Variation
variation-report · 2013-02-08 · EMA/62007/2013
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Abilify-H-C-471-II-0048 : EPAR - Assessment Report - Variation
variation-report · 2009-10-14 · EMEA/627485/2009
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Abilify-H-C-471-II-0041 : EPAR - Assessment Report - Variation
variation-report · 2008-08-13
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Abilify-H-C-471-II-0039 : EPAR - Assessment Report - Variation
variation-report · 2008-05-08
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Abilify-H-C-471-II-0015 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2007-02-13
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Abilify : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-10-30
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Abilify : EPAR - Scientific Discussion
scientific-discussion · 2006-10-30
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产品信息

Product information URLs for member states
product-information · 2026-11-13
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Abilify : EPAR - Product information - tracked changes
procedural-steps-after · 2026-01-12
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Abilify : EPAR - Product Information
product-information · 2026-01-12
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Abilify : EPAR - All Authorised presentations
all-authorised-presentations · 2014-06-12
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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。