Pradaxa
dabigatran etexilate
Table of contents
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.
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List item
Pradaxa : EPAR - Medicine overview (PDF/163.52 KB)
First published: 09/04/2008
Last updated: 17/03/2021
EMA/628110/2020 -
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List item
Pradaxa : EPAR - Risk-management-plan summary (PDF/7.23 MB)
First published: 22/03/2023
This EPAR was last updated on 22/03/2023
Authorisation details
Product details | |
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Name |
Pradaxa
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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) |
|
Anatomical therapeutic chemical (ATC) code |
B01AE07
|
Publication details | |
---|---|
Marketing-authorisation holder |
Boehringer Ingelheim International GmbH
|
Revision |
39
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Date of issue of marketing authorisation valid throughout the European Union |
17/03/2008
|
Contact address |
D-55216 Ingelheim am Rhein
Germany |
Product information
25/07/2022 Pradaxa - EMEA/H/C/000829 - N/0141
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Pharmacotherapeutic group
Antithrombotic agents
Therapeutic indication
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
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 November 202013/11/2020
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27/03/2020
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25/04/2014
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22/11/2013
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26/04/2013
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14/12/2012
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20/07/2012
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25/05/2012
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25/05/2012
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18/11/2011
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18/11/2011