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法规知识库 · EMA 集中审评

Apixaban Accord

apixaban · EMEA/H/C/005358 · 已授权

仿制药

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。

  1. 2026-07-24 · 欧委会决定

  2. 2020-07-23 · 获批上市许可

  3. 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 4产品信息 2其他 0

EPAR / 审评资料

  • Apixaban Accord : EPAR - Procedural steps taken and scientific information after the authorisation

    procedural-steps-after · 2026-07-27

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  • Apixaban Accord : EPAR - Risk management plan

    rmp · 2026-07-27

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  • Apixaban Accord : EPAR - Medicine overview

    overview · 2025-08-13 · EMA/296798/2020

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  • Apixaban Accord : EPAR - Public assessment report

    assessment-report · 2020-08-06 · EMA/322602/2020

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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。