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/00000022/202303
- Regulatory outcome
- Variation
Documents
Aceclofenac : List of nationally authorised medicinal products - PSUSA/00000022/202303
English (EN) (154.02 KB - PDF)
Aceclofenac : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000022/202303
English (EN) (96.51 KB - PDF)
български (BG) (172.27 KB - PDF)
español (ES) (139.06 KB - PDF)
čeština (CS) (193.37 KB - PDF)
dansk (DA) (148.41 KB - PDF)
Deutsch (DE) (149.38 KB - PDF)
eesti keel (ET) (141.46 KB - PDF)
ελληνικά (EL) (168.5 KB - PDF)
français (FR) (150.67 KB - PDF)
hrvatski (HR) (182.77 KB - PDF)
italiano (IT) (161.45 KB - PDF)
latviešu valoda (LV) (190.33 KB - PDF)
lietuvių kalba (LT) (186.36 KB - PDF)
magyar (HU) (211.39 KB - PDF)
Malti (MT) (184.12 KB - PDF)
Nederlands (NL) (160.21 KB - PDF)
polski (PL) (189.7 KB - PDF)
português (PT) (139.14 KB - PDF)
română (RO) (185.78 KB - PDF)
slovenčina (SK) (191.96 KB - PDF)
slovenščina (SL) (178.92 KB - PDF)
Suomi (FI) (140.57 KB - PDF)
svenska (SV) (155.07 KB - PDF)