PSUSA/00001309/201904 - periodic safety update report single assessment

Ethinylestradiol / levonorgestrel

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:
  Ethinylestradiol / levonorgestrel
• Procedure number:
  PSUSA/00001309/201904
• Regulatory outcome:
  Variation

Documents

Ethinylestradiol / levonorgestrel: List of nationally authorised medicinal products - PSUSA/00001309/201904

Reference Number: EMA/40774/2020

Ethinylestradiol / levonorgestrel: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00001309/201904