法规知识库 · EMA 集中审评
Eptifibatide Accord
eptifibatide · EMEA/H/C/004104 · 已授权
获批上市许可
2016-01-11
欧委会决定日
2025-05-02
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
8
官方索引 8
EPAR / 审评
5
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：B01AC16
治疗领域：Myocardial Infarction
药理分类：Antithrombotic agents
修订号：8 · 最新影响 PI 的程序：N/0000267275
适应症（原文）：Eptifibatide Accord is intended for use with acetylsalicylic acid and unfractionated heparin. Eptifibatide Accord is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina or non-Q-wave myocardial infarction, with the last episode of chest pain occurring within 24 hours and with electrocardiogram (ECG) changes and/or elevated cardiac enzymes. Patients most likely to benefit from Eptifibatide Accord treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early PTCA (Percutaneous Transluminal Coronary Angioplasty).
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。
2025-05-02 · 欧委会决定
2016-01-11 · 获批上市许可
2015-11-19 · 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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Eptifibatide Accord : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-05-02
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Eptifibatide Accord : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2023-04-21
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Eptifibatide Accord : EPAR - Risk-management-plan summary
rmp-summary · 2016-01-18 · EMA/20134/2016
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Eptifibatide Accord : EPAR - Public assessment report
assessment-report · 2016-01-18 · EMA/851528/2015
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Eptifibatide Accord : EPAR - Summary for the public
overview · 2016-01-18 · EMA/20928/2016
产品信息
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Eptifibatide Accord : EPAR – Product information - tracked changes
product-information-tracked-changes · 2025-05-02
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Eptifibatide Accord : EPAR - Product Information
product-information · 2025-05-02
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Eptifibatide Accord : EPAR - All Authorised presentations
all-authorised-presentations · 2016-01-18
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。