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
- Latanoprost (except for products with paediatric indication)
- Procedure number
- PSUSA/00001832/202104
- Regulatory outcome
- Variation
Documents
Latanoprost (except for products with paediatric indication) : List of nationally authorised medicinal products - PSUSA/00001832/202104
English (EN) (196.01 KB - PDF)
Latanoprost (except for products with paediatric indication) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001832/202104
English (EN) (157.66 KB - PDF)
български (BG) (194.29 KB - PDF)
español (ES) (162.67 KB - PDF)
čeština (CS) (189.32 KB - PDF)
dansk (DA) (155.05 KB - PDF)
Deutsch (DE) (138.59 KB - PDF)
eesti keel (ET) (151.45 KB - PDF)
ελληνικά (EL) (163.72 KB - PDF)
français (FR) (205.39 KB - PDF)
hrvatski (HR) (221.82 KB - PDF)
íslenska (IS) (139.41 KB - PDF)
italiano (IT) (178.36 KB - PDF)
latviešu valoda (LV) (202.45 KB - PDF)
lietuvių kalba (LT) (209.74 KB - PDF)
magyar (HU) (215.5 KB - PDF)
Malti (MT) (205.47 KB - PDF)
Nederlands (NL) (138.15 KB - PDF)
norsk (NO) (132.48 KB - PDF)
polski (PL) (197.71 KB - PDF)
português (PT) (154.13 KB - PDF)
română (RO) (199.37 KB - PDF)
slovenčina (SK) (187.17 KB - PDF)
slovenščina (SL) (219.79 KB - PDF)
Suomi (FI) (168.99 KB - PDF)
svenska (SV) (160.35 KB - PDF)