Label Changes for:

Pradaxa (Dabigatran Etexilate)

December 2012

Changes have been made to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2012

 

CONTRAINDICATIONS

  • Mechanical prosthetic heart valve
 
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