法规知识库 · EMA 集中审评
Bydureon
exenatide · EMEA/H/C/002020 · 已撤市
获批上市许可
2011-06-17
欧委会决定日
2024-11-20
持有人 / 申请人
AstraZeneca AB
终止日期字段
2026-01-01
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：A10BJ01
治疗领域：Diabetes Mellitus, Type 2
药理分类：Drugs used in diabetes
修订号：27 · 最新影响 PI 的程序：IB/0081
适应症（原文）：Bydureon is indicated in adults 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control (see section 4.4, 4.5 and 5.1 for available data on different combinations). Bydureon is indicated for treatment of type 2 diabetes mellitus in combination with: Metformin Sulphonylurea Thiazolidinedione Metformin and sulphonylurea Metformin and thiazolidinedione in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.
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。
2026-01-01 · 上市许可终止（撤市/失效/撤销等）
Withdrawn
2024-11-20 · 欧委会决定
2011-06-17 · 获批上市许可
2011-04-14 · 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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Bydureon : EPAR - Risk management plan summary
rmp-summary · 2026-10-02
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Bydureon-H-C-PSUSA-00009147-202003 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-10-02 · EMA/120245/2021
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Bydureon-H-C-2020-P46-028 : EPAR - Assessment report
variation-report · 2026-10-02 · EMA/94820/2021
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Bydureon-H-C-2020-X-0048-G : EPAR - Assessment Report - Extension
variation-report · 2026-10-02 · EMA/700805/2018
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Bydureon-H-C-002020-II-0045 : EPAR - Assessment report - Variation
variation-report · 2026-10-02 · EMA/717429/2017
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Bydureon-H-C-2020-II-0041 : EPAR - Assessment Report - Variation
variation-report · 2026-10-02 · EMA/538242/2017
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Bydureon-H-C-PSUSA-00009147-201503 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-10-02 · EMA/772289/2015
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Bydureon-H-C-2020-PSUV-0024 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-10-02 · EMA/52426/2015
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Bydureon-H-C-2020-PSUV-0018 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-10-02 · EMA/394090/2014
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Bydureon-H-C-2020-PSUV-0014 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-10-02 · EMA/CHMP/630136/2013
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Bydureon-H-C-2020-PSU-0014 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2026-10-02 · EMA/CHMP/780867/2013
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Bydureon : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-02
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Bydureon : EPAR - Summary for the public
overview · 2026-10-02
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Bydureon-H-C-002020-II-0073 : EPAR - Assessment report - Variation
variation-report · 2026-10-02 · EMA/CHMP/644257/2022
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Bydureon : EPAR - Public assessment report
assessment-report · 2026-10-02
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。