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/00010378/202305
- Regulatory outcome
- Variation
Documents
Mifepristone/Misoprostol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA-00010378-202305
English (EN) (144.23 KB - PDF)
български (BG) (129.72 KB - PDF)
español (ES) (314.35 KB - PDF)
čeština (CS) (113.29 KB - PDF)
dansk (DA) (119.55 KB - PDF)
Deutsch (DE) (154.33 KB - PDF)
eesti keel (ET) (114.6 KB - PDF)
ελληνικά (EL) (127.61 KB - PDF)
français (FR) (128.53 KB - PDF)
hrvatski (HR) (126.06 KB - PDF)
italiano (IT) (127.32 KB - PDF)
latviešu valoda (LV) (158.34 KB - PDF)
lietuvių kalba (LT) (156.95 KB - PDF)
magyar (HU) (122.28 KB - PDF)
Malti (MT) (467.12 KB - PDF)
Nederlands (NL) (126.28 KB - PDF)
polski (PL) (160.42 KB - PDF)
português (PT) (467.16 KB - PDF)
română (RO) (154.12 KB - PDF)
slovenčina (SK) (308.1 KB - PDF)
slovenščina (SL) (123.04 KB - PDF)
Suomi (FI) (125.59 KB - PDF)
svenska (SV) (118.91 KB - PDF)
Mifepristone/Misoprostol: List of nationally authorised medicinal products - PSUSA-00010378-202305
English (EN) (204.31 KB - PDF)