PSUSA/00009162/202403 - periodic safety update report single assessment

calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide

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:
  calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide
• Procedure number:
  PSUSA/00009162/202403
• Regulatory outcome:
  Maintenance

Documents

Calcium chloride/glutamic acid/glutathione/histidine/lactobionic acid/magnesium chloride/mannitol/potassium chloride/sodium hydroxide : List of nationally authorised medicinal products - PSUSA/00009162/202403

Reference Number: EMA/510665/2024