Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients

Safety of Potential Paediatric Patients Treated With Idarucizumab: a Non-internventional Chart Review Study

Idarucizumab is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with very high affinity. Idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises its anticoagulant effect. A clinical development program is ongoing to support marketing authorisation submissions for idarucizumab indicated in patients treated with dabigatran who require emergency surgery/urgent procedures or who have a life-threatening or uncontrolledbleeding when rapid reversal of the anticoagulant effects of dabigatran is required.

Purpose:

Study Design:

Inclusion criteria:

• Male or female, <18 years of age
• Were administered idarucizumab at sites and usage identified by various methods (eg.through the Idarucizumab drug administration surveillance program, spontaneous reporting)

Exclusion criteria:

Participation in a dabigatran or idarucizumab clinical trial