PSUSA/00010631/202412 - periodic safety update report single assessment

testosterone (all formulations apart from topical use)

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:
  testosterone (all formulations apart from topical use)
• Procedure number:
  PSUSA/00010631/202412
• Regulatory outcome:
  Variation

Documents

Testosterone (all formulations apart from topical use) : List of nationally authorised medicinal products - PSUSA/00000420/202411

Testosterone (all formulations apart from topical use) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000420/202411