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
- Amoxicillin
- Procedure number
- PSUSA/00010808/202203
- Regulatory outcome
- Variation
Documents
Erythromycin (systemic use) - List of nationally authorised medicinal products - PSUSA/00010808/202203
English (EN) (198.1 KB - PDF)
Erythromycin (systemic use) - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA/00010808/202203
English (EN) (135.72 KB - PDF)
български (BG) (125.94 KB - PDF)
español (ES) (127.87 KB - PDF)
čeština (CS) (119.84 KB - PDF)
dansk (DA) (118.5 KB - PDF)
Deutsch (DE) (135.84 KB - PDF)
eesti keel (ET) (133.42 KB - PDF)
ελληνικά (EL) (126.62 KB - PDF)
français (FR) (134.57 KB - PDF)
hrvatski (HR) (133.87 KB - PDF)
íslenska (IS) (138.04 KB - PDF)
Gaeilge (GA) (124.52 KB - PDF)
italiano (IT) (133.35 KB - PDF)
latviešu valoda (LV) (147.51 KB - PDF)
lietuvių kalba (LT) (136.96 KB - PDF)
magyar (HU) (138.66 KB - PDF)
Malti (MT) (136.63 KB - PDF)
Nederlands (NL) (129.74 KB - PDF)
norsk (NO) (126.6 KB - PDF)
polski (PL) (139.47 KB - PDF)
português (PT) (128.47 KB - PDF)
română (RO) (129.52 KB - PDF)
slovenčina (SK) (179.36 KB - PDF)
slovenščina (SL) (128.39 KB - PDF)
Suomi (FI) (127.32 KB - PDF)
svenska (SV) (128.23 KB - PDF)