PSUSA/00000304/201803 - periodic safety update report single assessment

BCG vaccine (freeze-dried)

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:
  BCG vaccine (freeze-dried)
• Procedure number:
  PSUSA/00000304/201803
• Regulatory outcome:
  Variation

Documents

BCG vaccine (freeze-dried): List of nationally authorised medicinal products - PSUSA/00000304/201803

Reference Number: EMA/270645/2015

BCG vaccine (freeze-dried): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000304/201803