PSUSA/00001854/201810 - periodic safety update report single assessment

Levofloxacin

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:
  Levofloxacin
• Procedure number:
  PSUSA/00001854/201810
• Regulatory outcome:
  Variation

Documents

Levofloxacin (except for the centrally authorised product): List of nationally authorised medicinal products - PSUSA/00001854/201810

Reference Number: EMA/397212/2019

Levofloxacin (except for the centrally authorised product): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001854/201810