PSUSA/00010855/202408 - periodic safety update report single assessment

hydrocortisone (systemic formulations except for products indicated in adrenal insufficiency in a modified release tablet formulation and except for centrally authorised products for adrenal insufficiency, paediatric use only)

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:
  hydrocortisone (systemic formulations except for products indicated in adrenal insufficiency in a modified release tablet formulation and except for centrally authorised products for adrenal insufficiency, paediatric use only)
• Procedure number:
  PSUSA/00010855/202408
• Regulatory outcome:
  Variation

Documents

Hydrocortisone (paediatric use only) : List of nationally authorised medicinal products - PSUSA/00010855/202408

Reference Number: EMA/189473/2025

Hydrocortisone (paediatric use only) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010855/202408