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Home Industry News Boehringer Ingelheim’s Pradaxa approved for stroke prevention

Boehringer Ingelheim’s Pradaxa approved for stroke prevention

8th August 2011

Boehringer Ingelheim has been granted European approval for its drug Pradaxa to be used to prevent stroke in patients with atrial fibrillation.

The European Commission has approved a label extension for the oral anticoagulant based on positive data from clinical trials, with two dosage strengths to be made available to cater to different patient groups.

It means that Pradaxa becomes the first drug to be ratified for use among this population in Europe for more than 50 years, providing a long-awaited alternative to vitamin K antagonist therapies.

Pradaxa has been available as a means of preventing venous thromboembolic events among surgery patients since 2008 and has also been approved in this new specification in nations such as the US, Japan and Australia.

Professor Andreas Barner, chairman of the board of managing directors at Boehringer Ingelheim, said: "We will now ensure that this new breakthrough treatment is made available to physicians and atrial fibrillation patients throughout Europe as soon as possible."

Last month, the company received a recommendation for European approval of the HIV drug Viramune from the Committee for Medicinal Products for Human Use.ADNFCR-8000103-ID-800692288-ADNFCR

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