PSUSA/00002472/202010 - periodic safety update report single assessment

Polystyrene sulfonate

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:
  Polystyrene sulfonate
• Procedure number:
  PSUSA/00002472/202010
• Regulatory outcome:
  Variation

Documents

Polystyrene sulfonate - List of nationally authorised medicinal products - PSUSA-00002472-202010

Reference Number: EMA/420759/2021

Polystyrene sulfonate - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00002472-202010