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
- Ropivacaine
- Procedure number
- PSUSA/00002662/202209
- Regulatory outcome
- Variation
Documents
Ropivacaine : List of nationally authorised medicinal products - PSUSA/00002662/202209
English (EN) (367.47 KB - PDF)
Ropivacaine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002662/202209
English (EN) (104.48 KB - PDF)
български (BG) (127.55 KB - PDF)
español (ES) (98.64 KB - PDF)
čeština (CS) (123.22 KB - PDF)
dansk (DA) (94.19 KB - PDF)
Deutsch (DE) (91.26 KB - PDF)
eesti keel (ET) (118.2 KB - PDF)
ελληνικά (EL) (145.91 KB - PDF)
français (FR) (91.75 KB - PDF)
hrvatski (HR) (118.72 KB - PDF)
íslenska (IS) (33.34 KB - PDF)
italiano (IT) (99.02 KB - PDF)
latviešu valoda (LV) (100.15 KB - PDF)
lietuvių kalba (LT) (121.28 KB - PDF)
magyar (HU) (92.62 KB - PDF)
Malti (MT) (130.9 KB - PDF)
Nederlands (NL) (89.4 KB - PDF)
norsk (NO) (90.11 KB - PDF)
polski (PL) (123.36 KB - PDF)
português (PT) (74.79 KB - PDF)
română (RO) (89.79 KB - PDF)
slovenčina (SK) (125.94 KB - PDF)
slovenščina (SL) (89.64 KB - PDF)
Suomi (FI) (85.22 KB - PDF)
svenska (SV) (88.61 KB - PDF)