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Olysio® (simeprevir) in combination with Sovaldi® (sofosbuvir): Risk of severe arrhythmias if used concomitantly with amiodarone

2015.08.21

Active substance: simeprevir, sofosbuvir

In accordance with the evaluation of cardiac safety of the concomitant administration of Harvoni®, Daklinza® and Sovaldi® with amiodarone, the Pharmacovigilance Risk Assessment Committee (PRAC) has also revised the medicinal product Olysio® (simeprevir) with regard to the risk of bradycardias.

To the risk information - full text (available in German only)