The evidence summary is based on data from the ongoing, uncontrolled, phase III RE‑VERSE AD study in patients currently on dabigatran but experiencing either serious bleeding or who require urgent surgery.
Idarucizumab is licensed for use in adults treated with dabigatran etexilate when rapid reversal of its anticoagulant effects is required for emergency surgery or urgent procedures, or in life‑threatening or uncontrolled bleeding.