Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Pradaxa   
Auth. number : EU/1/08/442
INN : dabigatran etexilate mesilate
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B01 - Antithrombotic agents
Pharmacological subgroup: B01A - Antithrombotic agents
Chemical subgroup: B01AE - Direct thrombin inhibitors
Chemical substance: B01AE07 - Dabigatran etexilate
(See WHO ATC Index)
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 nonvalvular atrial fibrillation with one or more of the following risk factors:
- Previous stroke, transient ischemic attack, or systemic embolism (SEE)
- 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
Marketing Authorisation Holder: Boehringer Ingelheim International GmbH
Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
20/03/2008 Centralised - Authorisation EMEA/H/C/829 (2008)1180 of 18/03/2008
10/04/2008 Corrigendum EMEA/H/C/829 (2008)1180 corr of 08/04/2008
18/04/2008 Centralised - Variation EMEA/H/C/829/IA/6
18/04/2008 Centralised - Variation EMEA/H/C/829/IA/4
09/06/2008 Centralised - Variation EMEA/H/C/829/IB/5
09/06/2008 Centralised - Variation EMEA/H/C/829/IB/7
11/06/2008 Centralised - Variation EMEA/H/C/829/IB/1
Updated with Decision(2009)1027 of 10/02/2009
30/06/2008 Centralised - Variation EMEA/H/C/829/II/3
04/08/2008 Centralised - Variation EMEA/H/C/829/II/2
23/10/2008 Centralised - Variation EMEA/H/C/829/IB/8
12/02/2009 Centralised - Variation (2009)1027 of 10/02/2009
02/03/2009 Centralised - Variation EMEA/H/C/829/II/9 (2009)1458 of 26/02/2009
27/03/2009 Centralised - Variation EMEA/H/C/829/II/10 (2009)2301 of 25/03/2009
24/08/2009 Centralised - Variation EMEA/H/C/829/II/12 (2009)6582 of 20/08/2009
02/11/2009 Centralised - Variation EMEA/H/C/829/II/11 (2009)8517 of 28/10/2009
05/07/2010 Centralised - Variation EMEA/H/C/829/II/14 (2010)4661 of 01/07/2010
30/08/2010 Centralised - Variation EMEA/H/C/829/II/17 (2010)6006 of 26/08/2010
27/10/2010 Centralised - Variation EMEA/H/C/829/II/15 (2010)7550 of 25/10/2010
20/12/2010 Centralised - Variation EMEA/H/C/829/N/19
Updated with Decision(2011)5694 of 01/08/2011
23/12/2010 Centralised - Variation EMEA/H/C/829/II/16 (2010)9616 of 20/12/2010
25/01/2011 Centralised - Variation EMEA/H/C/829/II/18 (2011)392 of 21/01/2011
02/08/2011 Centralised - Variation EMEA/H/C/829/X/13/G (2011)5693 of 01/08/2011
03/08/2011 Centralised - Variation EMEA/H/C/829/X/13/G (2011)5694 of 01/08/2011
01/12/2011 Centralised - Variation EMEA/H/C/829/II/22/127a to MAH (2011)8959 of 28/11/2011
28/12/2011 Centralised - Variation EMEA/H/C/829/II/22/127a to MS (2011)10118 of 22/12/2011
13/02/2012 Centralised - Variation EMEA/H/C/829/II/23/127a/MAH (2012)892 of 09/02/2012
13/02/2012 Centralised - Variation EMEA/H/C/829/IB/24/G
Updated with Decision(2012)892 of 09/02/2012
17/04/2012 Centralised - Variation EMEA/H/C/829/II/25 (2012)2537 of 13/04/2012
01/06/2012 Centralised - Variation EMEA/H/C/829/II/26, 29 (2012)3637 of 25/05/2012
21/06/2012 Centralised - Variation EMEA/H/C/829/IAin/35/G
Updated with Decision(2012)5471 of 26/07/2012
21/06/2012 Centralised - Variation EMEA/H/C/829/IAin/37/G
Updated with Decision(2012)5471 of 26/07/2012
03/07/2012 Centralised - Variation EMEA/H/C/829/II/31 (2012)4577 of 28/06/2012
06/07/2012 Centralised - Variation EMEA/H/C/829/IA/40/G
Updated with Decision(2012)6149 of 30/08/2012
30/07/2012 Centralised - Variation EMEA/H/C/829/II/32 (2012)5471 of 26/07/2012
03/09/2012 Centralised - Variation EMEA/H/C/829/II/32 (2012)6148 of 30/08/2012
05/09/2012 Centralised - Variation EMEA/H/C/829/II/28 (2012)6149 of 30/08/2012
13/12/2012 Centralised - Variation EMEA/H/C/829/II/43
Updated with Decision(2013)358 of 21/01/2013
22/01/2013 Centralised - Renewal EMEA/H/C/829/R/41 (2013)320 of 17/01/2013
23/01/2013 Centralised - Variation EMEA/H/C/829/II/44 (2013)358 of 21/01/2013
25/04/2013 Centralised - Variation EMEA/H/C/829/II/46
Updated with Decision(2013)4624 of 15/07/2013
25/04/2013 Centralised - Variation EMEA/H/C/829/II/45
Updated with Decision(2013)4624 of 15/07/2013
17/07/2013 Centralised - Modification EMEA/H/C/829/PSU/34 (2013)4624 of 15/07/2013
20/08/2013 Centralised - Variation EMEA/H/C/829/IB/50
Updated with Decision(2013)9716 of 18/12/2013
19/09/2013 Centralised - Variation EMEA/H/C/829/II/51
Updated with Decision(2013)9716 of 18/12/2013
19/09/2013 Centralised - Variation EMEA/H/C/829/II/49
Updated with Decision(2013)9716 of 18/12/2013
18/12/2013 Centralised - Variation EMEA/H/C/829/II/55
Updated with Decision(2014)3816 of 03/06/2014
02/01/2014 Centralised - Variation EMEA/H/C/829/II/52 (2013)9716 of 18/12/2013
25/04/2014 Centralised - Variation EMEA/H/C/829/II/61
Updated with Decision(2014)3816 of 03/06/2014
05/06/2014 Centralised - Variation EMEA/H/C/829/II/48 (2014)3816 of 03/06/2014
10/07/2014 Centralised - Variation EMEA/H/C/829/IA/70