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法规知识库 · EMA 集中审评

Dabigatran etexilate Teva (previously Dabigatran etexilate Leon Farma)

dabigatran etexilate mesilate · EMEA/H/C/005922 · 已授权

仿制药

获批上市许可

2024-02-19

欧委会决定日

2025-01-20

持有人 / 申请人

Teva GmbH

终止日期字段

无

从产品到官方文件

文件记录

2

官方索引 2

EPAR / 审评

2

assessment / overview 等

产品信息

0

PI / presentations

其他

0

RMP / PIP 等

ATC:B01AE07

治疗领域:Venous Thromboembolism;Arthroplasty, Replacement

药理分类:Antithrombotic agents

修订号:5 · 最新影响 PI 的程序:IB/0005/G

适应症(原文):Dabigatran etexilate Leon Farma 75 mg Primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. Treatment of VTE and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age. Dabigatran etexilate Leon Farma 110 mg Primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total 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 ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Treatment of VTE and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age. Dabigatran etexilate Leon Farma 150 mg 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 ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Treatment of venous thromboembolic events (VTE) and prevention of recurrent VTE in paediatric patients from birth 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. 2025-01-20 · 欧委会决定

  2. 2024-02-19 · 获批上市许可

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 2产品信息 0其他 0

EPAR / 审评资料

  • Dabigatran Etexilate Leon Farma : EPAR - Risk management plan

    rmp · 2024-09-26

    打开官方文件 ↗
  • Dabigatran Etexilate Leon Farma : EPAR - Public assessment report

    assessment-report · 2024-03-21 · EMA/12212/2024

    打开官方文件 ↗

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。