法规知识库 · EMA 集中审评
Mysimba
bupropion hydrochloride;naltrexone hydrochloride · EMEA/H/C/003687 · 已授权
获批上市许可
2015-03-26
欧委会决定日
2026-02-17
持有人 / 申请人
Orexigen Therapeutics Ireland Limited
终止日期字段
无
从产品到官方文件
文件记录
17
官方索引 17
EPAR / 审评
15
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：A08AA
治疗领域：Obesity;Overweight
药理分类：Antiobesity preparations, excl. diet products
修订号：33 · 最新影响 PI 的程序：VR/0000332676
适应症（原文）：Mysimba is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of ≥ 30 kg/m2 (obese), or ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension) Treatment with Mysimba should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight.
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。
2026-02-17 · 欧委会决定
2015-03-26 · 获批上市许可
2014-12-18 · 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
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Mysimba-PSUSA-00010366-202509 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-10-07 · EMADOC-1700519818-3492971
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Mysimba : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-07
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Mysimba : EPAR - Risk management plan
rmp · 2026-10-07
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Mysimba : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-11-06
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Mysimba-H-C-PSUSA-00010366-202409 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2025-07-25
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Mysimba-H-A-20-1530-C-3687-0065 : EPAR - Assessment report
variation-report · 2025-06-03 · EMA/101183/2025
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Mysimba : EPAR - Scientific conclusions - Annex IV
scientific-conclusion · 2025-06-03
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Mysimba-H-C-PSUSA-00010366-202209 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2023-07-21 · EMA/317738/2023
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Mysimba-H-C-PSUSA-00010366-202109: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-07-05 · EMA/621881/2022
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Mysimba-H-C-PSUSA-00010366-202009: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-07-13 · EMA/346967/2021
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Mysimba-H-C-PSUSA-00010366-201709 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-08-10 · EMA/328998/2018
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Mysimba-H-C-PSUSA-00010366-201703 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-02-06 · EMA/73378/2018
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Mysimba-H-C-PSUSA-00010366-201609 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-07-03 · EMA/CHMP/419376/2017
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Mysimba : EPAR - Public assessment report
assessment-report · 2015-04-15 · EMA/805547/2015
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Mysimba : EPAR - Summary for the public
overview · 2015-04-15
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。