PSUSA/00000546/202206 - periodic safety update report single assessment

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: Carbetocin
Procedure number: PSUSA/00000546/202206

Documents

Carbetocin - List of nationally authorised medicinal products - PSUSA/00000546/202206

Reference Number: EMA/160430/2023

English (EN) (155.61 KB - PDF)

First published: 05/04/2023

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Carbetocin - CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000546/202206

English (EN) (42.06 KB - PDF)