This medicinal product is subject to additional monitoring
Repeated doses of 200 mg ketoconazole daily resulted in a 17-fold increase in dronedarone exposure
Careful monitoring of digoxin levels is recommended
The EMA approval of ketoconazole for use as an antifungal agent was suspended in 2013 after the benefit-risk assessment was deemed to no longer be
Ketoconazole HRA is authorised for the treatment of endogenous Cushing’s syndrome in adults and adolescents
Company: HRA Pharma UK and Ireland Limited See contact details
Figure adapted from the EMA Public Assessment Report: Ketoconazole HRA [1]
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