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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
Details:
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
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