PSUSA/00010440/202108 - periodic safety update report single assessment

Estradiol (except cream/balm/emulsion for application in female genital area)

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 (except cream/balm/emulsion for application in female genital area)
• Procedure number:
  PSUSA/00010440/202108
• Regulatory outcome:
  Variation

Documents

Estradiol (except cream/balm/emulsion for application in female genital area) : List of nationally authorised medicinal products - PSUSA/00010440/202108

Reference Number: EMA/579444/2022

Estradiol (except cream/balm/emulsion for application in female genital area) : CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010440/202108