PSUSA/00002199/201701 - periodic safety update report single assessment

Octenidine dihydrochloride / phenoxyethanol

Popis

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:
  Octenidine dihydrochloride / phenoxyethanol
• Procedure number:
  PSUSA/00002199/201701
• Regulatory outcome:
  Variation

Dokumenty

Octenidine dihydrochloride / phenoxyethanol: List of nationally authorised medicinal products - PSUSA/00002199/201701

Reference Number: EMA/706786/2017

Octenidine dihydrochloride / phenoxyethanol: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002199/201701