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            Lead Product(s): Dabigatran Etexilate Mesylate

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: Pradaxa

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 16, 2020


            Positive opinion is based on a dedicated clinical pediatric program for dabigatran, including the DIVERSITY study,2 which supplements dabigatran's established and well-documented safety and efficacy profile in adults