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genisi

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genisi

Re: DewDiligence post# 151852

Wednesday, 11/07/2012 4:45:19 AM

Wednesday, November 07, 2012 4:45:19 AM

Post# of 252254
The Pradaxa label was revised and updated several times as seen in the first link you've posted "Label and Approval History". Your secound link is indeed the most recent update (Revised: 11/2012), after FDA’s study of the bleeding issue. My reply to Clark points to an earlier revision and update on the need to assess and monitor renal function and lower dose if required.
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