Biotech Values

[genisi]

the FDA analysis of the Pradaxa data indicates with some moderately high confidence that the increased bleeding that happens with Pradaxa as patients get older is largely independent of renal function.

Still, the label was revised earlier this year to include the need to assess and monitor renal function and lower dose if required.

http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing%20Information/PIs/Pradaxa/Pradaxa.pdf