法规知识库 · EMA 集中审评
Apixaban Accord
apixaban · EMEA/H/C/005358 · 已授权
获批上市许可
2020-07-23
欧委会决定日
2026-07-24
持有人 / 申请人
Accord Healthcare S.L.U.
终止日期字段
无
从产品到官方文件
文件记录
6
官方索引 6
EPAR / 审评
4
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:B01AF02
治疗领域:Venous Thromboembolism;Stroke;Arthroplasty
药理分类:Antithrombotic agents
修订号:8 · 最新影响 PI 的程序:VR/0000357501
适应症(原文):Adults Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients). Paediatric population Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. Adults Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients). Paediatric population Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age.
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。
2026-07-24 · 欧委会决定
2020-07-23 · 获批上市许可
2020-05-28 · 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
- 打开官方文件 ↗
Apixaban Accord : EPAR - Procedural steps taken and scientific information after the authorisation
procedural-steps-after · 2026-07-27
- 打开官方文件 ↗
Apixaban Accord : EPAR - Risk management plan
rmp · 2026-07-27
- 打开官方文件 ↗
Apixaban Accord : EPAR - Medicine overview
overview · 2025-08-13 · EMA/296798/2020
- 打开官方文件 ↗
Apixaban Accord : EPAR - Public assessment report
assessment-report · 2020-08-06 · EMA/322602/2020
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。