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

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. 2024-05-10 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetySummary Safety ReviewPRADAXAdabigatran etexilateassessingpotential riskliver injury Summary Safety Review - PRADAXA (dabigatran etexilate) - Assessing the potential risk of liver injuryHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/pradaxa-assessing-potential-risk-liver-injury.html Summary Safety Review - PRADAXA (dabigatran etexilate) - Assessing the potential risk of liver injuryHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada/examens-innocuite/pradaxa-evaluation-risque-potentiel-lesions-foie.html

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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