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
- Hydroxycarbamide (except for centrally authorised product)
- Procedure number
- PSUSA/00009182/202012
- Regulatory outcome
- Variation
Documents
Hydroxycarbamide : List of nationally authorised medicinal products - PSUSA/00009182/202012
English (EN) (140.17 KB - PDF)
Hydroxycarbamide : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation, amendments to the Product Information and timetable for the implementation - PSUSA/00009182/202012
English (EN) (93.78 KB - PDF)
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