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Boehringer Ingelheim GmbH Release: FDA and FDA Reaffirm Important Health Benefits and Safety of Pradaxa® (dabigatran etexilate) for Patients With Atrial Fibrillation  
11/5/2012 9:55:43 AM

INGELHEIM, Germany--(BUSINESS WIRE)--For Non-US, Non-UK & Non-Canadian Media Only: Following independent regulatory appraisals of the safety and efficacy of the anticoagulation therapy Pradaxa®, both the U.S. Food and Drug Administration (FDA) and European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) have reconfirmed the positive benefit-risk profile of the treatment for prevention of stroke in patients with atrial fibrillation (AF)*.
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