Dabigatran etexilate Teva is an anticoagulant medicine (a medicine that prevents blood clotting) 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 blood clot in a blood vessel supplying the lungs) in adults, and preventing these conditions from occurring again; * treating blood clots in veins in children and preventing them from occurring again. Dabigatran etexilate Teva contains the active substance dabigatran etexilate. Dabigatran etexilate Teva is a ‘generic medicine’. This means that it 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 Teva is Pradaxa. For more information on generic medicines, see the question\-and\-answer document [here](https://www.ema.europa.eu/en/documents/other/questions-and-answers-generic-medicines_en.pdf).
Therapeutic Indication
**Dabigatran etexilate Leon Farma 75 mg** Primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. Treatment of VTE and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age. **Dabigatran etexilate Leon Farma 110 mg** Primary prevention of venous thromboembolic events (VTE) 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. Treatment of VTE and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age. **Dabigatran etexilate Leon Farma 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 Treatment of venous thromboembolic events (VTE) and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age.
Therapeutic Area (MeSH)
ATC Code
B01AE07
ATC Item
N/A
Pharmacotherapeutic Group
Antithrombotic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| dabigatran etexilate mesilate | N/A | dabigatran etexilate mesilate |
EMA Name
Dabigatran etexilate Teva (previously Dabigatran etexilate Leon Farma)
Medicine Name
Dabigatran etexilate Teva (previously Dabigatran etexilate Leon Farma)
Aliases
N/ANo risk management plan link.
