Summary Safety Review - PRADAXA (dabigatran etexilate) - Assessing the potential risk of liver injury

Health Canada reviewed the potential risk of liver injury with Pradaxa after receiving reports of severe liver injury from the manufacturer. The manufacturer was asked to provide all available data on Pradaxa and the risk of liver injury.

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Dernière modification avril 17, 2026, 17:39 (TU)
Créé le avril 17, 2026, 17:39 (TU)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2018-05-07 00:00:00
open_canada_keywords {"fr": ["Résumé de l'examen de l'innocuité", "PRADAXA", "dabigatran etexilate", "évaluation", "risque potentiel", "lésion hépatique"], "en": ["Summary Safety Review", "PRADAXA", "dabigatran etexilate", "assessing", "potential risk", "liver injury"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Résumé de l’examen de l’innocuité - PRADAXA (dabigatran étexilate) - Évaluation du risque potentiel de lésions du foie
update_frequency as_needed