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
- Tapentadol
- Procedure number
- PSUSA/00002849/202111
- Regulatory outcome
- Variation
Documents
Tapentadol : List of nationally authorised medicinal products - PSUSA/00002849/202111
English (EN) (938.11 KB - PDF)
Tapentadol : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00002849/202111
English (EN) (129.49 KB - PDF)
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čeština (CS) (165.3 KB - PDF)
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français (FR) (135.2 KB - PDF)
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italiano (IT) (143.36 KB - PDF)
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Nederlands (NL) (137.75 KB - PDF)
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polski (PL) (170.91 KB - PDF)
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