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
- Clarithromycin
- Procedure number
- PSUSA/00000788/202004
- Regulatory outcome
- Variation
Documents
Clarithromycin: CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000788/202004
English (EN) (153.91 KB - PDF)
български (BG) (183.36 KB - PDF)
español (ES) (83.37 KB - PDF)
čeština (CS) (115.63 KB - PDF)
dansk (DA) (244.63 KB - PDF)
Deutsch (DE) (39.45 KB - PDF)
eesti keel (ET) (83.63 KB - PDF)
ελληνικά (EL) (108.24 KB - PDF)
français (FR) (82.6 KB - PDF)
hrvatski (HR) (154.75 KB - PDF)
íslenska (IS) (187.06 KB - PDF)
italiano (IT) (83.63 KB - PDF)
latviešu valoda (LV) (111.47 KB - PDF)
lietuvių kalba (LT) (158.34 KB - PDF)
magyar (HU) (183.61 KB - PDF)
Malti (MT) (170.99 KB - PDF)
Nederlands (NL) (37.57 KB - PDF)
norsk (NO) (186.28 KB - PDF)
polski (PL) (163.13 KB - PDF)
português (PT) (82.79 KB - PDF)
română (RO) (159.82 KB - PDF)
slovenčina (SK) (175.4 KB - PDF)
slovenščina (SL) (182.84 KB - PDF)
Suomi (FI) (82.87 KB - PDF)
svenska (SV) (79.72 KB - PDF)
Clarithromycin: List of nationally authorised medicinal products - PSUSA/00000788/202004
English (EN) (383.21 KB - PDF)