PSUSA/00001126/202507 - periodic safety update report single assessment

diphtheria / tetanus / pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed), diphtheria / tetanus / pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)

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:
  diphtheria / tetanus / pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed), diphtheria / tetanus / pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)
• Procedure number:
  PSUSA/00001126/202507
• Regulatory outcome:
  Maintenance

Documents

Diphtheria / tetanus / pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed)....(adsorbed, reduced antigen(s) content) - List of nationally authorised medicinal products - PSUSA/00001126/202507

Reference Number: EMADOC-1700519818-2982954