法规知识库 · EMA 集中审评
Selincro
nalmefene hydrochloride dihydrate · EMEA/H/C/002583 · 已授权
获批上市许可
2013-02-24
欧委会决定日
2025-10-07
持有人 / 申请人
H. Lundbeck A/S
终止日期字段
无
从产品到官方文件
文件记录
11
官方索引 11
EPAR / 审评
9
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：N07BB05
治疗领域：Alcohol-Related Disorders
药理分类：Drugs used in alcohol dependence
修订号：15 · 最新影响 PI 的程序：N/0000302832
适应症（原文）：Selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking-risk level (see section 5.1), without physical withdrawal symptoms and who do not require immediate detoxification. Selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption. Selincro should be initiated only in patients who continue to have a high drinking-risk level two weeks after initial assessment.
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。
2025-10-07 · 欧委会决定
2013-02-24 · 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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Selincro : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-10-07
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Selincro : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-10-07
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Selincro-H-C-PSUSA-00010120-202102 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-01-13 · EMA/17065/2022
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Selincro-H-C-PSUSA-00010120-201802 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-12-11 · EMA/856642/2018
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Selincro-H-C-PSUSA-00010120-201702 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-12-15 · EMA/821625/2017
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Selincro-H-C-PSUSA-00010120-201602 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-07-07 · EMA/432132/2017
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Selincro-H-C-2583-PSUSA-00010120-201408 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-07-08 · EMA/CHMP/268466/2015
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Selincro : EPAR - Summary for the public
overview · 2013-03-13
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Selincro : EPAR - Public assessment report
assessment-report · 2013-03-13
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。