欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Arixtra
适用类别Human
治疗领域Venous Thrombosis;Pulmonary Embolism;Myocardial Infarction;Angina, Unstable
通用名/非专利名称fondaparinux sodium
活性成分fondaparinux sodium
产品号EMEA/H/C/000403
患者安全信息No
许可状态Authorised
ATC编码B01AX05
是否额外监管Nei
是否仿制药或hybrid药物Nei
是否生物类似药Nei
是否附条件批准Nei
是否特殊情形Nei
是否加速审评Nei
是否罕用药Nei
上市许可日期2002/03/20
上市许可开发者/申请人/持有人Viatris Healthcare Limited
人用药物治疗学分组Antithrombotic agents
兽用药物治疗学分组
审评意见日期2010/07/22
欧盟委员会决定日期2024/03/21
修订号36
治疗适应症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.
适用物种
兽用药物ATC编码
首次发布日期2018/03/21
最后更新日期2024/03/27
产品说明书https://www.ema.europa.eu/en/documents/product-information/arixtra-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/arixtra
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