PSUSA/00010374/202401 - periodic safety update report single assessment
amitriptyline, amitriptyline / amitriptylinoxide, amitriptylinoxide
PSUSAHuman
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Despre
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
- amitriptyline, amitriptyline / amitriptylinoxide, amitriptylinoxide
- Procedure number
- PSUSA/00010374/202401
- Regulatory outcome
- Variation