PSUSA/00001696/202011 - periodic safety update report single assessment

Hydroxyzine chloride / hydroxyzine pamoate and all fixed combination, hydroxyzine

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:
  Hydroxyzine chloride / hydroxyzine pamoate and all fixed combination, hydroxyzine
• Procedure number:
  PSUSA/00001696/202011
• Regulatory outcome:
  Variation

Documents

Hydroxyzine chloride / hydroxyzine pamoate and all fixed combination, hydroxyzine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001696/202011

Hydroxyzine chloride / hydroxyzine pamoate and all fixed combination, hydroxyzine: List of nationally authorised medicinal products - PSUSA/00001696/202011

Reference Number: EMA/474182/2021