The European Commission has given the green light for Boehringer Ingelheim’s oral anticoagulant Pradaxa, which is used to prevent strokes.
Pradaxa has been specifically approved for the prevention of strokes in patients with atrial fibrillation in doses of 150mg BID, while a 110mg BID dose has been approved for use in patients aged 80 years or older.
The drug had previously been cleared to prevent blood clots after hip and knee surgery. The latest approval was recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use earlier this year.
Pradaxa has already been approved for the prevention of strokes in the US, Canada, Japan and Australia.