5-fluorouracil (intravenous) – Scientific findings and reasons for changing the conditions of the marketing authorization – PSUSA-00000007-202012

2021-11-09T14:55:56+03:00

Taking into account the available data on risk (s) from the literature and spontaneous reports, including in some cases a close temporal relationship, positive challenge-response, and/or re-challenge, PRAC consider that - the relationship between 5-fluorouracil (IV) and cutaneous lupus erythematosus - the relationship between 5-fluorouracil (IV) and stress cardiomyopathy (takotsubo syndrome) - the relationship between [...]