Dabigatran Etexilate Accord


dabigatran etexilate

This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 31/05/2023

Authorisation details

Product details
Dabigatran Etexilate Accord
Agency product number
Active substance
Dabigatran etexilate mesilate
International non-proprietary name (INN) or common name
dabigatran etexilate
Therapeutic area (MeSH)
  • Venous Thromboembolism
  • Arthroplasty, Replacement
Anatomical therapeutic chemical (ATC) code

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
Marketing-authorisation holder
Accord Healthcare S.L.U.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Accord Healthcare S.L.U.
Edificio Este Planta 6a
World Trade Center
Moll De Barcelona S/n
08039 Barcelona

Product information

Dabigatran Etexilate Accord - EMEA/H/C/005639 -

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Product information documents contain:

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

Assessment history

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