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

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

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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

Dokumenti

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