PSUSA/00010648/202106 - periodic safety update report single assessment

Triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without mineral compounds/electrolytes (i.v. application)

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:
  Triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without mineral compounds/electrolytes (i.v. application)
• Procedure number:
  PSUSA/00010648/202106
• Regulatory outcome:
  Maintenance

Documents

Triglyceride combinations (e.g. olive oil, soya bean oil, fish oil)/ with or without mineral compounds/electrolytes (i.v. application) : List of nationally authorised medicinal products - PSUSA/00010648/202106

Reference Number: EMA/32337/2022