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
- Metamizole
- Procedure number
- PSUSA/00001997/202103
- Regulatory outcome
- Variation
Documents
Metamizole : List of nationally authorised medicines - PSUSA/00001997/202103
English (EN) (148.83 KB - PDF)
Metamizole : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001997/202103
English (EN) (142.77 KB - PDF)
български (BG) (171.78 KB - PDF)
español (ES) (147.02 KB - PDF)
čeština (CS) (245.6 KB - PDF)
dansk (DA) (149.02 KB - PDF)
Deutsch (DE) (181.53 KB - PDF)
eesti keel (ET) (145.01 KB - PDF)
ελληνικά (EL) (174.43 KB - PDF)
français (FR) (148.59 KB - PDF)
hrvatski (HR) (185.37 KB - PDF)
italiano (IT) (147.1 KB - PDF)
latviešu valoda (LV) (181.38 KB - PDF)
lietuvių kalba (LT) (187.65 KB - PDF)
magyar (HU) (182.94 KB - PDF)
Malti (MT) (192.4 KB - PDF)
Nederlands (NL) (149.71 KB - PDF)
polski (PL) (178.98 KB - PDF)
português (PT) (148.77 KB - PDF)
română (RO) (173.77 KB - PDF)
slovenčina (SK) (175.63 KB - PDF)
slovenščina (SL) (171.18 KB - PDF)
Suomi (FI) (144.52 KB - PDF)
svenska (SV) (146.71 KB - PDF)