PSUSA/00003006/202503 - periodic safety update report single assessment

tranexamic acid

Sobre

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:
  tranexamic acid
• Procedure number:
  PSUSA/00003006/202503
• Regulatory outcome:
  Variation

Documents

Tranexamic acid : List of nationally authorised medicinal products - PSUSA/00003006/202503

Reference Number: EMADOC-1700519818-2852321

Tranexamic acid : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00003006/202503