PSUSA/00001270/202204 - periodic safety update report single assessment

Esomeprazole / naproxen

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:
  Esomeprazole / naproxen
• Procedure number:
  PSUSA/00001270/202204
• Regulatory outcome:
  Variation

Documents

Esomeprazole / naproxen : List of nationally authorised medicinal products - PSUSA/00001270/202204

Reference Number: EMA/108915/2023

Esomeprazole / naproxen : CMDh scientific conclusions, amendments to product information and implementation timetable - PSUSA/00001270/202204

Reference Number: EMA/108915/2023