dabigatran etexilate

This medicine is authorised for use in the European Union.


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
Agency product number
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
Publication details
Marketing-authorisation holder
Boehringer Ingelheim International GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address
D-55216 Ingelheim am Rhein

Product information

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


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Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

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 with one or more of the following risk factors:

  • previous stroke, transient ischaemic attack or systemic embolism;
  • left ventricular ejection fraction < 40%;
  • symptomatic heart failure ≥ New York Heart Association (NYHA) class 2;
  • age ≥ 75 years;
  • age ≥ 65 years associated with one of the following: diabetes mellitus, coronary artery disease or hypertension.

Assessment history

Changes since initial authorisation of medicine

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