PSUSA/00010508/202509 - periodic safety update report single assessment

metronidazole / neomycin / nystatin

Informácie o

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:
  metronidazole / neomycin / nystatin
• Procedure number:
  PSUSA/00010508/202509
• Regulatory outcome:
  Variation

Dokumenty

Metronidazole / neomycin / nystatin : List of nationally authorised medicinal products - PSUSA/00010508/202509

Reference Number: EMADOC-1700519818-3215414

Metronidazole / neomycin / nystatin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010508/202509