Press Release: European Medicines Agency updates on safety of Pradaxa

Author (Corporate)
Series Title
Series Details EMA/CHMP/903767/2011 (18.11.11)
Publication Date 18/11/2011
Content Type

The European Medicines Agency, on 18 November 2011, provided an update on the safety of the anticoagulant medicine Pradaxa (dabigatran etexilate).

Pradaxa has been authorised since March 2008 for primary prevention of venous thromboembolic events in adults who have had elective total hip replacement surgery or total knee replacement surgery. Since August 2011, it is also authorised for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.

Source Link http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/11/news_detail_001390.jsp&mid=WC0b01ac058004d5c1&jsenabled=true
Related Links
EMA: Press Release: EMA/CHMP/903767/2011 (18.11.11) http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2011/11/WC500117818.pdf

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