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法规知识库 · EMA 集中审评

Quixidar

fondaparinux sodium · EMEA/H/C/000404 · 已撤市

获批上市许可

2002-03-21

欧委会决定日

2007-10-24

持有人 / 申请人

Glaxo Group Ltd.

终止日期字段

2008-03-11

从产品到官方文件

文件记录

11

官方索引 11

EPAR / 审评

9

assessment / overview 等

产品信息

2

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:10 · 最新影响 PI 的程序:N/0034

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 patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery. Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery (see section 5.1). Prevention of Venous Thromboembolic Events (VTE) in 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. 2.5 mg/0.5 ml, solution for injection: Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated (see sections 4.4 and 5.1). Treatment of ST segment elevation myocardial infarction (STEMI) in 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 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。

  1. 2008-03-11 · 上市许可终止(撤市/失效/撤销等)

    Withdrawn

  2. 2007-10-24 · 欧委会决定

  3. 2002-03-21 · 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 9产品信息 2其他 0

EPAR / 审评资料

  • Quixidar-H-C-404-II-24 : EPAR - Scientific Discussion - Variation

    scientific-discussion-variation · 2008-05-16

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  • Quixidar-H-C-404-II-10 : EPAR - Scientific Discussion - Variation

    scientific-discussion-variation · 2008-05-16

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  • Quixidar : EPAR - Scientific Discussion

    scientific-discussion · 2008-05-16

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  • Quixidar : EPAR - Procedural steps taken and scientific information after authorisation

    procedural-steps-after · 2008-05-16

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  • Quixidar : EPAR - Procedural steps taken before authorisation

    procedural-steps-before · 2008-05-16

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  • Quixidar-H-C-404-II-12 : EPAR - Scientific Discussion - Variation

    scientific-discussion-variation · 2008-05-16

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  • Quixidar : EPAR - Summary for the public

    overview · 2008-05-16

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  • Quixidar : EPAR - Steps taken after authorisation when a cutoff date has been used

    steps-after-cutoff · 2008-05-16

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  • Quixidar-H-C-404-X-25 : EPAR - Scientific Discussion - Variation

    scientific-discussion-variation · 2008-05-16

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产品信息

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。