About

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.

Key facts

Active substance(s) in scope of the PSUSA procedure
Estradiol, estradiol /prednisolone (only cream/balm/emulsion for application in the female genital area)
Procedure number
PSUSA/00010441/201704
Regulatory outcome
Maintenance

Documents

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