法规知识库 · EMA 集中审评
Integrilin
eptifibatide · EMEA/H/C/000230 · 已撤市
获批上市许可
1999-07-01
欧委会决定日
2021-09-24
持有人 / 申请人
GlaxoSmithKline Trading Services Limited
终止日期字段
2026-01-01
从产品到官方文件
文件记录
7
官方索引 7
EPAR / 审评
5
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：B01AC16
治疗领域：Angina, Unstable;Myocardial Infarction
药理分类：Antithrombotic agents
修订号：27 · 最新影响 PI 的程序：N/0088
适应症（原文）：Integrilin is intended for use with acetylsalicylic acid and unfractionated heparin. Integrilin is indicated for the prevention of early myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction with the last episode of chest pain occurring within 24 hours and with ECG changes and / or elevated cardiac enzymes. Patients most likely to benefit from Integrilin 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 percutaneous transluminal coronary angioplasty (PTCA).
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Withdrawn
2021-09-24 · 欧委会决定
1999-07-02 · CHMP 意见通过
1999-07-01 · 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
- 打开官方文件 ↗
Integrilin : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2022-03-17
- 打开官方文件 ↗
Integrilin : EPAR - Summary for the public
overview · 2009-09-02
- 打开官方文件 ↗
Integrilin : EPAR - Scientific Discussion
scientific-discussion · 2006-07-10
- 打开官方文件 ↗
Integrilin : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-07-10
- 打开官方文件 ↗
Integrilin : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2006-07-10
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。