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Pradaxa (dabigatran etexilate)

Region
🇪🇺 EU
Active substance
dabigatran etexilate
Company
Boehringer Ingelheim International GmbH
Status
Authorised
Therapeutic area
Arthroplasty, Replacement; Venous Thromboembolism
EU approval
Mon 17 Mar 2008
Application
EMEA/H/C/000829
ATC
B01AE07
Official record
www.ema.europa.eu

Indication

Pradaxa 75 mg Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. Pradaxa 110 mg Primary prevention of venous thromboembolic events 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. Pradaxa 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.

Regulatory milestones

No milestones recorded in the last year.

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.