法规知识库 · EMA 集中审评
Arixtra
fondaparinux sodium · EMEA/H/C/000403 · 已授权
获批上市许可
2002-03-20
欧委会决定日
2026-05-05
持有人 / 申请人
Viatris Healthcare Limited
终止日期字段
无
从产品到官方文件
文件记录
16
官方索引 16
EPAR / 审评
13
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：B01AX05
治疗领域：Venous Thrombosis;Pulmonary Embolism;Myocardial Infarction;Angina, Unstable
药理分类：Antithrombotic agents
修订号：40 · 最新影响 PI 的程序：VR/0000325156
适应症（原文）：1.5-mg/0.3-ml and 2.5-mg/0.5-ml solution for injection Prevention of venous thromboembolic events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery. Prevention of VTE in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery. Prevention of VTE in adult medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and / or acute respiratory disorders, and / or acute infectious or inflammatory disease. Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis. 2.5-mg/0.5-ml solution for injection Treatment of unstable angina or non-ST-segment-elevation myocardial infarction (UA/NSTEMI) in adult patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated. infarction (STEMI) in adult patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy. 5-mg/0.4-ml, 7.5-mg/0.6-ml and 10-mg/0.8-ml solution for injection Treatment of adults with acute deep-vein thrombosis (DVT) and treatment of acute pulmonary embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.
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。
2026-05-05 · 欧委会决定
2010-07-22 · CHMP 意见通过
2002-03-20 · 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 ↗
Arixtra : EPAR - Risk management plan
rmp · 2026-08-18
- 打开官方文件 ↗
Arixtra : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-05-07
- 打开官方文件 ↗
Arixtra : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-01-29
- 打开官方文件 ↗
Arixtra-H-C-PSUSA-00001467-201512 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-11-08 · EMA/CHMP/493771/2016
- 打开官方文件 ↗
Arixtra-H-C-403-II-45 : EPAR - Assessment Report - Variation
variation-report · 2010-10-08
- 打开官方文件 ↗
Arixtra : EPAR - Summary for the public
overview · 2010-10-08
- 打开官方文件 ↗
Arixtra-H-C-403-X-25 : EPAR - Scientific Discussion - Extension
scientific-discussion-variation · 2007-11-20
- 打开官方文件 ↗
Arixtra-H-C-403-II-24 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2007-11-20
- 打开官方文件 ↗
Arixtra : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2005-11-04
- 打开官方文件 ↗
Arixtra : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2005-11-04
- 打开官方文件 ↗
Arixtra-H-C-403-II-10 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2005-11-04
- 打开官方文件 ↗
Arixtra-H-C-403-II-12 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2005-11-04
- 打开官方文件 ↗
Arixtra : EPAR - Scientific Discussion
scientific-discussion · 2005-11-04
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。