PSUSA/00010465/201912 - periodic safety update report single assessment
Allergen for therapy: Dactylis Glomerata L., Phleum Pratense L., Anthoxanthum Odoratum L., Lolium Perenne L., Poa Pratensis L. (sublingual tablet)
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.