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
- Hydroxychloroquine
- Procedure number
- PSUSA/00001693/202104
- Regulatory outcome
- Variation
Documents
Hydroxychloroquine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001693/202104
English (EN) (109.26 KB - PDF)
български (BG) (123.2 KB - PDF)
español (ES) (107.67 KB - PDF)
čeština (CS) (401.98 KB - PDF)
dansk (DA) (234.94 KB - PDF)
Deutsch (DE) (218.41 KB - PDF)
eesti keel (ET) (182.6 KB - PDF)
ελληνικά (EL) (90.08 KB - PDF)
français (FR) (149.65 KB - PDF)
hrvatski (HR) (121.54 KB - PDF)
íslenska (IS) (134.54 KB - PDF)
Gaeilge (GA) (109.99 KB - PDF)
italiano (IT) (139.43 KB - PDF)
latviešu valoda (LV) (253.91 KB - PDF)
lietuvių kalba (LT) (274.46 KB - PDF)
magyar (HU) (179.68 KB - PDF)
Malti (MT) (190 KB - PDF)
Nederlands (NL) (134.22 KB - PDF)
norsk (NO) (129.92 KB - PDF)
polski (PL) (122.49 KB - PDF)
português (PT) (113.86 KB - PDF)
română (RO) (229.61 KB - PDF)
slovenčina (SK) (228.57 KB - PDF)
slovenščina (SL) (109.34 KB - PDF)
Suomi (FI) (101.66 KB - PDF)
svenska (SV) (141.59 KB - PDF)
Hydroxychloroquine : List of nationally authorised medicinal products - PSUSA/00001693/202104
English (EN) (131.71 KB - PDF)