法规知识库 · EMA 集中审评
Aripiprazole Accord
aripiprazole · EMEA/H/C/004021 · 已授权
获批上市许可
2015-11-15
欧委会决定日
2025-02-24
持有人 / 申请人
Accord Healthcare S.L.U.
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
5
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：N05AX12
治疗领域：Schizophrenia;Bipolar Disorder
药理分类：Psycholeptics
修订号：16 · 最新影响 PI 的程序：VR/0000254891
适应症（原文）：Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Accord 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. Aripiprazole Accord 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。
2025-02-24 · 欧委会决定
2015-11-15 · 获批上市许可
2015-09-23 · 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
- 打开官方文件 ↗
Aripiprazole Accord : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-02-26
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Aripiprazole Accord : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2022-07-13
- 打开官方文件 ↗
Aripiprazole Accord : EPAR - Public assessment report
assessment-report · 2015-11-27 · EMA/CHMP/523618/2015
- 打开官方文件 ↗
Aripiprazole Accord : EPAR - Summary for the public
overview · 2015-11-27 · EMA/634874/2015
- 打开官方文件 ↗
Aripiprazole Accord : EPAR - Risk-management-plan summary
rmp-summary · 2015-11-27 · EMA/16634/2014
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。