Pradaxa

RSS

dabigatran etexilate

Authorised
This medicine is authorised for use in the European Union.

Overview

Pradaxa is an anticoagulant medicine used for:

  • preventing the formation of blood clots in the veins in adults who have had an operation to replacea hip or knee;
  • preventing stroke and the formation of clots in adults who have an abnormal heartbeat called ‘non-valvular atrial fibrillation’ and are considered to be at risk of stroke;
  • treating deep vein thrombosis (DVT, a blood clot in a deep vein, usually in the leg) and pulmonaryembolism (PE, a clot in a blood vessel supplying the lungs) in adults, and preventing theseconditions from occurring again.

Pradaxa contains the active substance dabigatran etexilate.

This EPAR was last updated on 23/01/2020

Authorisation details

Product details
Name
Pradaxa
Agency product number
EMEA/H/C/000829
Active substance
Dabigatran etexilate mesilate
International non-proprietary name (INN) or common name
dabigatran etexilate
Therapeutic area (MeSH)
  • Arthroplasty, Replacement
  • Venous Thromboembolism
Anatomical therapeutic chemical (ATC) code
B01AE07
Publication details
Marketing-authorisation holder
Boehringer Ingelheim International GmbH
Revision
30
Date of issue of marketing authorisation valid throughout the European Union
17/03/2008
Contact address
D-55216 Ingelheim am Rhein
Germany

Product information

16/12/2019 Pradaxa - EMEA/H/C/000829 - II/0118/G

Contents

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Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Pradaxa 75 mg

  • Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.

Pradaxa 110 mg

  • Primary prevention of venous thromboembolic events 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.

Pradaxa 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.

Assessment history

Changes since initial authorisation of medicine

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