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 replace a hip or knee;
  • preventing stroke (caused by a blood clot in the brain) and systemic embolism (a blood clot in another organ) 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 pulmonary embolism (PE, a clot in a blood vessel supplying the lungs) in adults, and preventing these conditions from occurring again.
  • treating blood clots in veins and preventing them from occurring again in children

Pradaxa contains the active substance dabigatran etexilate.

This EPAR was last updated on 24/11/2023

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
40
Date of issue of marketing authorisation valid throughout the European Union
17/03/2008
Contact address
D-55216 Ingelheim am Rhein
Germany

Product information

20/11/2023 Pradaxa - EMEA/H/C/000829 - N/0148

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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

Related content

How useful was this page?

Add your rating
Average
4 ratings
1 rating
1 rating
6 ratings