PSUSA/00010392/201905 - periodic safety update report single assessment

Macrogol 4000, macrogol 4000 combinations (oral use)

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:
  Macrogol 4000, macrogol 4000 combinations (oral use)
• Procedure number:
  PSUSA/00010392/201905
• Regulatory outcome:
  Maintenance

Documents

Macrogol 4000, macrogol 4000 combinations (oral use): List of nationally authorised medicinal products - PSUSA/00010392/201905

Reference Number: EMA/36889/2020