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/00010354/202305
- Regulatory outcome
- Variation
Documents
Misoprostol (gynaecological indication - termination of pregnancy) : List of nationally authorised medicinal products - PSUSA/00010354/202305
English (EN) (222.33 KB - PDF)
Misoprostol (gynaecological indication - termination of pregnancy) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010354/202305
English (EN) (119.51 KB - PDF)
български (BG) (115.81 KB - PDF)
español (ES) (97.41 KB - PDF)
čeština (CS) (154.37 KB - PDF)
dansk (DA) (157.74 KB - PDF)
Deutsch (DE) (109.6 KB - PDF)
eesti keel (ET) (94.15 KB - PDF)
ελληνικά (EL) (134.29 KB - PDF)
français (FR) (114.57 KB - PDF)
hrvatski (HR) (156.74 KB - PDF)
íslenska (IS) (125.37 KB - PDF)
italiano (IT) (224.51 KB - PDF)
latviešu valoda (LV) (167.66 KB - PDF)
lietuvių kalba (LT) (199.65 KB - PDF)
magyar (HU) (128.18 KB - PDF)
Malti (MT) (150.88 KB - PDF)
Nederlands (NL) (234.5 KB - PDF)
norsk (NO) (99.91 KB - PDF)
polski (PL) (134.73 KB - PDF)
português (PT) (92.02 KB - PDF)
română (RO) (120.82 KB - PDF)
slovenčina (SK) (162.43 KB - PDF)
Suomi (FI) (194.89 KB - PDF)
svenska (SV) (194.3 KB - PDF)