法规知识库 · EMA 集中审评
Ozempic
semaglutide · EMEA/H/C/004174 · 已授权
获批上市许可
2018-02-08
欧委会决定日
2026-06-11
持有人 / 申请人
Novo Nordisk A/S
终止日期字段
无
从产品到官方文件
文件记录
13
官方索引 13
EPAR / 审评
10
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：A10BJ06
治疗领域：Diabetes Mellitus
药理分类：Drugs used in diabetes
修订号：22 · 最新影响 PI 的程序：VR/0000339049
适应症（原文）：Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise: as monotherapy when metformin is considered inappropriate due to intolerance or contraindications; in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
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。
2026-06-11 · 欧委会决定
2018-02-08 · 获批上市许可
2017-11-09 · 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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Ozempic : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-08-25
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Ozempic : EPAR - Risk management plan
rmp · 2026-03-25
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Ozempic : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-02-13
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Ozempic-H-C-PSUSA-00010671-202205 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2023-05-03 · EMA/193347/2023
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Ozempic-H-C-004174-X-0021 : EPAR - Assessment report - Variation
variation-report · 2022-02-23 · EMA/21773/2022
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Ozempic-H-C-PSUSA-00010671-202005 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-04-28 · EMA/114770/2021
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Ozempic-H-C-PSUSA-00010671-201911 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-01-11 · EMA/11051/2021
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Ozempic-H-C-PSUSA-00010671-201905 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2020-04-07 · EMA/173542/2020
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Ozempic : EPAR - Public assessment report
assessment-report · 2018-02-21 · EMA/CHMP/715701/2017
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Ozempic : EPAR - Summary for the public
overview · 2018-02-21
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。