PSUSA/00010808/202203 - periodic safety update report single assessment
Amoxicillin
PSUSA
Human
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
Reference Number: EMA/759360/2022
English (EN) (198.1 KB - PDF)
First published:
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)
First published:
български (BG) (125.94 KB - PDF)
First published:
10/01/2023
español (ES) (127.87 KB - PDF)
First published:
10/01/2023
čeština (CS) (119.84 KB - PDF)
First published:
10/01/2023
dansk (DA) (118.5 KB - PDF)
First published:
10/01/2023
Deutsch (DE) (135.84 KB - PDF)
First published:
10/01/2023
eesti keel (ET) (133.42 KB - PDF)
First published:
10/01/2023
ελληνικά (EL) (126.62 KB - PDF)
First published:
10/01/2023
français (FR) (134.57 KB - PDF)
First published:
10/01/2023
hrvatski (HR) (133.87 KB - PDF)
First published:
10/01/2023
íslenska (IS) (138.04 KB - PDF)
First published:
10/01/2023
Gaeilge (GA) (124.52 KB - PDF)
First published:
10/01/2023
italiano (IT) (133.35 KB - PDF)
First published:
10/01/2023
latviešu valoda (LV) (147.51 KB - PDF)
First published:
10/01/2023
lietuvių kalba (LT) (136.96 KB - PDF)
First published:
10/01/2023
magyar (HU) (138.66 KB - PDF)
First published:
10/01/2023
Malti (MT) (136.63 KB - PDF)
First published:
10/01/2023
Nederlands (NL) (129.74 KB - PDF)
First published:
10/01/2023
norsk (NO) (126.6 KB - PDF)
First published:
10/01/2023
polski (PL) (139.47 KB - PDF)
First published:
10/01/2023
português (PT) (128.47 KB - PDF)
First published:
10/01/2023
română (RO) (129.52 KB - PDF)
First published:
10/01/2023
slovenčina (SK) (179.36 KB - PDF)
First published:
10/01/2023
slovenščina (SL) (128.39 KB - PDF)
First published:
10/01/2023
Suomi (FI) (127.32 KB - PDF)
First published:
10/01/2023
svenska (SV) (128.23 KB - PDF)
First published:
10/01/2023