PSUSA/00010440/201608 - periodic safety update report single assessment
Estradiol (except cream/balm/emulsion for application in female genital area)
PSUSAHuman
Periodic safety update report single assessments (PSUSAs) are single assessments of related periodic safety update reports (PSURs) for active substances contained in medicines authorised in the European Union (EU). A PSUR is a pharmacovigilance report submitted regularly by a marketing-authorisation holder at defined time points following a medicine's authorisation.