Basic Information
Dabigatran Etexilate Accord
Regulatory Information
EMEA/H/C/005639
May 26, 2023
March 30, 2023
2
August 12, 2024
Company Information
Spain
Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona
ACCORD HEALTHCARE SL
Drug Classification
Active Substances Detail
Dabigatran etexilate mesilate
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Prevention of venous thromboembolic events
Overview Summary
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](https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-generic-medicines_en.pdf). Dabigatran Etexilate Accord contains the active substance dabigatran etexilate.