PSUSA/00010488/202505 - periodic safety update report single assessment

isotretinoin (oral formulations)

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:
  isotretinoin (oral formulations)
• Procedure number:
  PSUSA/00010488/202505
• Regulatory outcome:
  Variation

Documents

Isotretinoin (oral formulations) : List of nationally authorised medicinal products - PSUSA/00010488/202505

Reference Number: EMADOC-1700519818-2824312

Isotretinoin (oral formulations) : Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s) - PSUSA/00010488/202505