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)

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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

Dokumenter

Hydrocortisone (systemic formulations) : List of nationally authorised medicinal products - PSUSA/00010855/202408

Reference Number: EMA/189473/2025

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