Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 19 June 2018

Indication(s)

- Pradaxa 75 mg hard capsules:
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 hard capsules:
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 hard capsules:
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.

Full Prescribing information

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More information

Category Value
Agency product number EMEA/H/C/000829
Orphan designation No
Date First Approved 18-03-2008
Type Medicinal product subject to medical prescription
Marketing authorisation holder Boehringer Ingelheim International GmbH