PSUSA/00010693/202404 - periodic safety update report single assessment

Ambrosia Artemisiifolia (302) (sublingual use, products authorised via decentralised procedure)

À propos

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:
  Ambrosia Artemisiifolia (302) (sublingual use, products authorised via decentralised procedure)
• Procedure number:
  PSUSA/00010693/202404
• Regulatory outcome:
  Variation

Documents

Ambrosia Artemisiifolia (302) (sublingual use, products authorised via decentralised procedure) : List of nationally authorised medicinal products - PSUSA/00010693/202404

Reference Number: EMA/28467/2025

Ambrosia Artemisiifolia (302) (sublingual use, products authorised via decentralised procedure) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010693/202404