PSUSA/00001693/202104 - periodic safety update report single assessment
Hydroxychloroquine
PSUSA
Human
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)
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български (BG) (123.2 KB - PDF)
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24/01/2022
español (ES) (107.67 KB - PDF)
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24/01/2022
čeština (CS) (401.98 KB - PDF)
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24/01/2022
dansk (DA) (234.94 KB - PDF)
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24/01/2022
Deutsch (DE) (218.41 KB - PDF)
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24/01/2022
eesti keel (ET) (182.6 KB - PDF)
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24/01/2022
ελληνικά (EL) (90.08 KB - PDF)
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24/01/2022
français (FR) (149.65 KB - PDF)
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24/01/2022
hrvatski (HR) (121.54 KB - PDF)
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24/01/2022
íslenska (IS) (134.54 KB - PDF)
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24/01/2022
Gaeilge (GA) (109.99 KB - PDF)
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24/01/2022
italiano (IT) (139.43 KB - PDF)
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24/01/2022
latviešu valoda (LV) (253.91 KB - PDF)
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24/01/2022
lietuvių kalba (LT) (274.46 KB - PDF)
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24/01/2022
magyar (HU) (179.68 KB - PDF)
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24/01/2022
Malti (MT) (190 KB - PDF)
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24/01/2022
Nederlands (NL) (134.22 KB - PDF)
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24/01/2022
norsk (NO) (129.92 KB - PDF)
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24/01/2022
polski (PL) (122.49 KB - PDF)
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24/01/2022
português (PT) (113.86 KB - PDF)
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24/01/2022
română (RO) (229.61 KB - PDF)
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24/01/2022
slovenčina (SK) (228.57 KB - PDF)
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24/01/2022
slovenščina (SL) (109.34 KB - PDF)
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24/01/2022
Suomi (FI) (101.66 KB - PDF)
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24/01/2022
svenska (SV) (141.59 KB - PDF)
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24/01/2022
Hydroxychloroquine : List of nationally authorised medicinal products - PSUSA/00001693/202104
Reference Number: EMA/502667/2021
English (EN) (131.71 KB - PDF)
First published: