法规知识库 · EMA 集中审评
Xarelto
rivaroxaban · EMEA/H/C/000944 · 已授权
获批上市许可
2008-09-30
欧委会决定日
2026-09-22
持有人 / 申请人
Bayer AG
终止日期字段
无
从产品到官方文件
文件记录
24
官方索引 24
EPAR / 审评
22
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：B01AF01
治疗领域：Arthroplasty, Replacement;Venous Thromboembolism
药理分类：Antithrombotic agents
修订号：43 · 最新影响 PI 的程序：VR/0000369601
适应症（原文）：Xarelto, 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. Xarelto, 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.
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。
2026-09-22 · 欧委会决定
2008-09-30 · 获批上市许可
2008-07-24 · CHMP 意见通过
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
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Xarelto : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-09-22
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Xarelto : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-09-22
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Xarelto : EPAR - Risk-management-plan
rmp · 2024-06-03
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Xarelto-H-C-PSUSA-00002653-202209 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2023-08-02 · EMA/352754/2023
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Xarelto-H-C-000944-P46-050 : EPAR - Assessment Report
variation-report · 2023-01-18 · EMEA/214680/2021
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Xarelto-H-C-PSR-S-0027 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-12-14 · EMA/940159/2022
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Xarelto-H-C-PSUSA-00002653-202009 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-07-13 · EMA/346994/2021
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Xarelto : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan
pip-compliance · 2021-07-13 · EMA/207785/2021
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Xarelto-H-C-944-X-0074-G : EPAR - Assessment Report - Variation
variation-report · 2021-02-02 · EMA/647126/2020
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Xarelto : EPAR - Medicine overview
overview · 2021-02-02 · EMA/617633/2020
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Xarelto-H-C-944-II-0058 : EPAR - Assessment Report - Variation
variation-report · 2018-09-06 · EMA/556022/2018
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Xarelto-H-C-000944-P46-042 : EPAR - Assessment Report
variation-report · 2018-07-27 · EMA/77663/2018
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Xarelto-H-C-PSUSA-00002653-201709 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2018-07-19 · EMA/497511/2018
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Xarelto-H-C-PSUSA-00002653-201609 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-06-30 · EMA/416305/2017
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Xarelto-H-C-944-LEG-0037 : EPAR - Assessment Report - Variation
variation-report · 2016-02-10 · EMA/CHMP/87883/2016
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Xarelto-H-C-944-II-0023: EPAR - Assessment Report - Variation
variation-report · 2013-10-11 · EMA/380964/2013
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Xarelto-H-C-944-X-0017 : EPAR - Assessment Report - Extension
variation-report · 2013-06-24 · EMA/CHMP/794349/2012
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Xarelto-H-C-944-II-0018 : EPAR - Assessment Report - Variation
variation-report · 2013-02-05 · EMA/56019/2013
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Xarelto : EPAR - Conditions imposed on member states for safe and effective use
conditions-member-states · 2012-02-08
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Xarelto-H-C-944-II-0012 : EPAR - Assessment Report - Variation
variation-report · 2012-01-20 · EMA/42547/2012
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Xarelto-H-C-944-X-0010 : EPAR - Assessment Report - Extension
variation-report · 2012-01-20 · EMA/CHMP/301607/2011
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Xarelto : EPAR - Public assessment report
assessment-report · 2008-11-10
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。