PSUSA/00002057/202209 - periodic safety update report single assessment

Midazolam (all pharmaceutical forms and indications apart from oromucosal solution indicated for the treatment of prolonged, acute, convulsive seizures)

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:
  Midazolam (all pharmaceutical forms and indications apart from oromucosal solution indicated for the treatment of prolonged, acute, convulsive seizures)
• Procedure number:
  PSUSA/00002057/202209
• Regulatory outcome:
  Variation

Documents

Midazolam (all pharmaceutical forms and indications apart from oromucosal solution indicated for the treatment of prolonged, acute, convulsive seizures) : List of nationally authorised medicinal products - PSUSA/00002057/202209

Reference Number: EMA/253285/2023

Midazolam (all pharmaceutical forms and indications apart from oromucosal solution....) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002057/202209