Can I read Pediatric Safety Review of Pradaxa on EtoBox?

Pediatric Safety Review of Pradaxa by andersonln1184 is a document available to read on EtoBox.

What is Pediatric Safety Review of Pradaxa about?

This document is a pediatric postmarketing pharmacovigilance review for Pradaxa (dabigatran etexilate) conducted by the FDA, focusing on serious adverse events in patients under 18 years of age. The review found no new safety signals or deaths associated with the drug in this population, and all serious reports were excluded from further discussion. The review was prompted by recent pediatric labeling changes and covers data from October 19, 2010, to April 2, 2024.

Author

andersonln1184

Language

EN