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
- Procedure number
- PSUSA/00002165/202306
- Regulatory outcome
- Variation
Documents
Nimesulide (topical formulations) : List of nationally authorised medicinal products - PSUSA/00002655/202306
English (EN) (164.21 KB - PDF)
Nimesulide (topical formulations) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002655/202306
English (EN) (130.48 KB - PDF)
български (BG) (182.77 KB - PDF)
español (ES) (132.7 KB - PDF)
čeština (CS) (178.41 KB - PDF)
dansk (DA) (131.63 KB - PDF)
Deutsch (DE) (142.04 KB - PDF)
eesti keel (ET) (125.39 KB - PDF)
ελληνικά (EL) (164.26 KB - PDF)
français (FR) (134.66 KB - PDF)
hrvatski (HR) (173.43 KB - PDF)
italiano (IT) (141.79 KB - PDF)
latviešu valoda (LV) (176.57 KB - PDF)
lietuvių kalba (LT) (170.71 KB - PDF)
magyar (HU) (198.75 KB - PDF)
Malti (MT) (198.16 KB - PDF)
Nederlands (NL) (142.15 KB - PDF)
polski (PL) (178.84 KB - PDF)
português (PT) (134.48 KB - PDF)
română (RO) (177.15 KB - PDF)
slovenčina (SK) (179.22 KB - PDF)
slovenščina (SL) (170.32 KB - PDF)
Suomi (FI) (127.14 KB - PDF)
svenska (SV) (131.22 KB - PDF)