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/00002661/202207
- Regulatory outcome
- Variation
Documents
Ropinirole - List of nationally authorised medicinal products - PSUSA/00002661/202207
English (EN) (347 KB - PDF)
Ropinirole - CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002661/202207
English (EN) (124.35 KB - PDF)
български (BG) (140.11 KB - PDF)
español (ES) (81.87 KB - PDF)
čeština (CS) (137.14 KB - PDF)
dansk (DA) (135.36 KB - PDF)
Deutsch (DE) (163.97 KB - PDF)
eesti keel (ET) (121.71 KB - PDF)
ελληνικά (EL) (118.42 KB - PDF)
français (FR) (138.46 KB - PDF)
hrvatski (HR) (225.22 KB - PDF)
íslenska (IS) (123.3 KB - PDF)
italiano (IT) (162.28 KB - PDF)
latviešu valoda (LV) (209.48 KB - PDF)
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magyar (HU) (125.68 KB - PDF)
Malti (MT) (229.76 KB - PDF)
Nederlands (NL) (149.97 KB - PDF)
norsk (NO) (104.93 KB - PDF)
polski (PL) (209.99 KB - PDF)
português (PT) (194 KB - PDF)
română (RO) (226.62 KB - PDF)
slovenčina (SK) (134.24 KB - PDF)
slovenščina (SL) (195.33 KB - PDF)
Suomi (FI) (80.45 KB - PDF)
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