Pradaxa

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dabigatran etexilate

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

Overview

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.

This EPAR was last updated on 15/06/2018

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
27
Date of issue of marketing authorisation valid throughout the European Union
18/03/2008
Contact address
D-55216 Ingelheim am Rhein
Germany

Product information

07/06/2018 Pradaxa - EMEA/H/C/000829 - II/0108

Contents

  • 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.

You are therefore advised to be selective about which sections or pages you wish to print.

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

  • List item

    Pradaxa-H-C-829-P46-046 : EPAR - Assessment Report (PDF/440.98 KB)


    First published: 13/03/2017
    Last updated: 13/03/2017
    EMA/171046/2017

  • List item

    Pradaxa-H-C-829-P46-045.1 : EPAR - Assessment Report (PDF/321.33 KB)


    First published: 10/03/2017
    Last updated: 10/03/2017

  • List item

    Pradaxa-H-C-829-II-0048-G : EPAR - Assessment Report - Variation (PDF/5.45 MB)

    Adopted

    First published: 17/07/2014
    Last updated: 17/07/2014
    EMA/CHMP/2014

  • List item

    CHMP post-authorisation summary of positive opinion for Pradaxa (PDF/97.57 KB)

    Adopted

    First published: 25/04/2014
    Last updated: 25/04/2014
    EMA/252976/2014

  • List item

    Pradaxa-H-C-829-II-0055 : EPAR - Assessment Report - Variation (PDF/137.24 KB)

    Adopted

    First published: 19/03/2014
    Last updated: 19/03/2014
    EMA/784266/2013

  • List item

    CHMP post-authorisation summary of positive opinion for Pradaxa (PDF/66.42 KB)

    Adopted

    First published: 20/12/2013
    Last updated: 20/12/2013
    EMA/CHMP/804118/2013

  • List item

    Pradaxa-H-C-829-P46-0033 : EPAR - Assessment Report (PDF/829.47 KB)

    Adopted

    First published: 17/12/2013
    Last updated: 17/12/2013
    EMA/CHMP/653299/2013

  • List item

    CHMP post-authorisation summary of positive opinion for Pradaxa (PDF/91.81 KB)

    Adopted

    First published: 22/11/2013
    Last updated: 22/11/2013
    EMA/CHMP/719108/2013

  • List item

    Pradaxa H-C-829-PSU-0034 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/72.23 KB)

    Adopted

    First published: 05/09/2013
    Last updated: 05/09/2013
    EMA/CHMP/229779/2013

  • List item

    Pradaxa-H-C-829-PSU-0034 : EPAR - Assessment Report – Periodic safety update report (PDF/679.52 KB)

    Adopted

    First published: 05/09/2013
    Last updated: 05/09/2013
    EMA/PRAC/212356/2013

  • List item

    CHMP post-authorisation summary of positive opinion for Pradaxa (PDF/74.03 KB)

    Adopted

    First published: 26/04/2013
    Last updated: 26/04/2013
    EMA/CHMP/261823/2013

  • List item

    CHMP post-authorisation summary of positive opinion for Pradaxa (PDF/74.72 KB)


    First published: 14/12/2012
    Last updated: 14/12/2012
    EMA/804086/2012

  • List item

    Pradaxa-H-C-829-II-0031 : EPAR - Assessment Report - Variation (PDF/495.65 KB)

    Adopted

    First published: 04/09/2012
    Last updated: 04/09/2012
    EMA/556143/2012

  • List item

    CHMP post-authorisation positive summary of opinion for Pradaxa (PDF/96.42 KB)

    Adopted

    First published: 20/07/2012
    Last updated: 20/07/2012
    EMA/337034/2012

  • List item

    CHMP post-authorisation summary of positive opinion for Pradaxa (PDF/62.61 KB)

    Adopted

    First published: 25/05/2012
    Last updated: 04/06/2012
    EMA/337053/2012

  • List item

    Pradaxa-H-C-829-X-13 : EPAR - Assessment Report - Extension (PDF/1.07 MB)

    Adopted

    First published: 23/08/2011
    Last updated: 23/08/2011
    EMA/CHMP/203468/2011

  • List item

    CHMP post-authorisation summary of positive opinion for Pradaxa (PDF/78.77 KB)

    Adopted

    First published: 15/04/2011
    Last updated: 15/04/2011
    EMA/CHMP/304146/2011

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