Dabigatran etexilate Teva (previously Dabigatran etexilate Leon Farma) (dabigatran etexilate)
- Region
- 🇪🇺 EU
- Active substance
- dabigatran etexilate
- Company
- Teva GmbH
- Status
- Authorised
- Therapeutic area
- Venous Thromboembolism; Arthroplasty, Replacement
- EU approval
- Mon 19 Feb 2024
- Designations
- Generic
- Application
- EMEA/H/C/005922
- ATC
- B01AE07
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Pradaxa Authorised · Boehringer Ingelheim International GmbH
- 🇪🇺 Dabigatran Etexilate Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Dabigatran etexilate Teva Application withdrawn · Teva GmbH
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