Amiodarone — Scientific findings and reasons for changing the conditions of the marketing authorization — PSUSA-00000166-202012


In view of the available data found in the literature and spontaneous reports, including those describing the chronology of drug interactions between Amiodarone and Sirolimus, leading to increased toxicity of Sirolimus, PRAC considers the estimated cumulative data to be sufficient to support a causal relationship. The PRAC concluded that the information on products containing Amiodarone [...]