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
- Carbidopa / levodopa
- Procedure number
- PSUSA/00000548/201910
- Regulatory outcome
- Variation
Documents
Carbidopa / levodopa: List of nationally authorised medicinal products - PSUSA/00000548/201910
English (EN) (268.88 KB - PDF)
Carbidopa / levodopa: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000548/201910
English (EN) (658.43 KB - PDF)
български (BG) (694.1 KB - PDF)
español (ES) (98.73 KB - PDF)
čeština (CS) (661.44 KB - PDF)
dansk (DA) (99.81 KB - PDF)
Deutsch (DE) (705.32 KB - PDF)
eesti keel (ET) (109.05 KB - PDF)
ελληνικά (EL) (99.14 KB - PDF)
français (FR) (104.13 KB - PDF)
hrvatski (HR) (115.72 KB - PDF)
íslenska (IS) (104.08 KB - PDF)
italiano (IT) (705.75 KB - PDF)
latviešu valoda (LV) (668.71 KB - PDF)
lietuvių kalba (LT) (109.83 KB - PDF)
magyar (HU) (104.24 KB - PDF)
Malti (MT) (795.53 KB - PDF)
Nederlands (NL) (77.87 KB - PDF)
norsk (NO) (100.34 KB - PDF)
polski (PL) (105.62 KB - PDF)
português (PT) (104.35 KB - PDF)
română (RO) (104.68 KB - PDF)
slovenčina (SK) (102.28 KB - PDF)
slovenščina (SL) (684.29 KB - PDF)
Suomi (FI) (100.36 KB - PDF)
svenska (SV) (101.41 KB - PDF)