This is a summary of the European public assessment report (EPAR) for Pradaxa. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pradaxa.
Pradaxa : EPAR - Summary for the public (PDF/91.42 KB)
First published: 09/04/2008
Last updated: 18/02/2015
|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||
06/06/2018 Pradaxa - EMEA/H/C/000829 - II/0108
- 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
Please note that the size of the above document can exceed 50 pages.
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- 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.
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