PSUSA/00010328/201908 - periodic safety update report single assessment

Hydrocortisone (except for products indicated in adrenal insufficiency in a modified release tablet formulation)

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 (except for products indicated in adrenal insufficiency in a modified release tablet formulation)
• Procedure number:
  PSUSA/00010328/201908
• Regulatory outcome:
  Variation

Documents

Hydrocortisone (except for products indicated in adrenal insufficiency in a modified release tablet formulation): List of nationally authorised medicinal products - PSUSA/00010328/201908

Reference Number: EMA/311363/2020

Hydrocortisone (except for products indicated in adrenal insufficiency in a modified release tablet: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010328/201908