欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Rivaroxaban Viatris (previously Rivaroxaban Mylan)
适用类别Human
治疗领域Venous Thromboembolism;Pulmonary Embolism;Acute Coronary Syndrome;Stroke;Coronary Artery Disease;Peripheral Arterial Disease;Atrial Fibrillation
通用名/非专利名称rivaroxaban
活性成分rivaroxaban
产品号EMEA/H/C/005600
患者安全信息No
许可状态Authorised
ATC编码B01AF01
是否额外监管Nei
是否仿制药或hybrid药物
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2021/11/12
上市许可开发者/申请人/持有人Viatris 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2021/09/16
欧盟委员会决定日期2025/11/05
修订号10
治疗适应症Rivaroxaban Mylan co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers.  Rivaroxaban Mylan co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.  ------ Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.  Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. ------- Adults  Prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Paediatric population  Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. Paediatric population  Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.  
适用物种
兽用药物ATC编码
首次发布日期2021/09/14
最后更新日期2025/11/05
产品说明书https://www.ema.europa.eu/en/documents/product-information/rivaroxaban-viatris-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/rivaroxaban-viatris
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