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
- Ropinirole
- Procedure number
- PSUSA/00002661/201907
- Regulatory outcome
- Variation
Documents
Ropinirole: List of nationally authorised medicinal products - PSUSA/00002661201907
English (EN) (313.67 KB - PDF)
Ropinirole: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002661201907
English (EN) (372.33 KB - PDF)
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čeština (CS) (174.28 KB - PDF)
dansk (DA) (43.75 KB - PDF)
Deutsch (DE) (44.92 KB - PDF)
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hrvatski (HR) (135.13 KB - PDF)
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italiano (IT) (49.66 KB - PDF)
latviešu valoda (LV) (168.72 KB - PDF)
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Malti (MT) (131.95 KB - PDF)
Nederlands (NL) (36.82 KB - PDF)
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polski (PL) (131.15 KB - PDF)
português (PT) (365.77 KB - PDF)
română (RO) (501.25 KB - PDF)
slovenčina (SK) (157.66 KB - PDF)
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