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.
Pradaxa : EPAR - Medicine overview (PDF/162.01 KB) (updated)
First published: 09/04/2008
Last updated: 23/01/2020
|Agency product number||
Dabigatran etexilate mesilate
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Boehringer Ingelheim International GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
16/12/2019 Pradaxa - EMEA/H/C/000829 - II/0118/G
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 November 201322/11/2013
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 201214/12/2012
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 November 201118/11/2011