Dabigatran Etexilate Accord
dabigatran etexilate
Table of contents
Overview
Dabigatran Etexilate Accord 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.
Dabigatran Etexilate Accord is a ‘generic medicine’. This means that Dabigatran Etexilate Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Dabigatran Etexilate Accord is Pradaxa. For more information on generic medicines, see the question-and-answer document here.
Dabigatran Etexilate Accord contains the active substance dabigatran etexilate.
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List item
Dabigatran Etexilate Accord : EPAR - Medicine Overview (PDF/110.69 KB)
First published: 31/05/2023
EMA/162570/2023 -
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Dabigatran Etexilate Accord : EPAR - Risk management plan summary (PDF/116.71 KB)
First published: 31/05/2023
Authorisation details
Product details | |
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Name |
Dabigatran Etexilate Accord
|
Agency product number |
EMEA/H/C/005639
|
Active substance |
Dabigatran etexilate mesilate
|
International non-proprietary name (INN) or common name |
dabigatran etexilate
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
B01AE07
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
Publication details | |
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Marketing-authorisation holder |
Accord Healthcare S.L.U.
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Date of issue of marketing authorisation valid throughout the European Union |
26/05/2023
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Contact address |
Accord Healthcare S.L.U. |
Product information
Dabigatran Etexilate Accord - EMEA/H/C/005639 -
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
Antithrombotic agents
Therapeutic indication
Prevention of venous thromboembolic events