Архивы PRAC - Национальный научный центр Фармаконадзора

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

Елена Матвеева2021-11-08T17:12:39+03:00

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 [...]

Amiodarone — Scientific findings and reasons for changing the conditions of the marketing authorization — PSUSA-00000166-202012Елена Матвеева2021-11-08T17:12:39+03:00

Safety variations for Ponatinib

Елена Матвеева2021-10-25T16:42:33+03:00

After reviewing the available evidence and evaluating the evidence provided by the relevant Marketing Authorization Holder (MAH), PRAC agreed that the product information for Ponatinib should be updated to reflect the risk of panniculitis. data source and details

Safety variations for PonatinibЕлена Матвеева2021-10-25T16:42:33+03:00