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
- Donepezil
- Procedure number
- PSUSA/00001160/202111
- Regulatory outcome
- Variation
Documents
Donepezil : List of nationally authorised medicinal products - PSUSA/00001160/202111
English (EN) (282.97 KB - PDF)
Donepezil : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001160/202111
English (EN) (80.33 KB - PDF)
български (BG) (112.4 KB - PDF)
español (ES) (109.01 KB - PDF)
čeština (CS) (97.11 KB - PDF)
dansk (DA) (104.65 KB - PDF)
Deutsch (DE) (113.79 KB - PDF)
eesti keel (ET) (102.48 KB - PDF)
ελληνικά (EL) (102.37 KB - PDF)
français (FR) (104.98 KB - PDF)
hrvatski (HR) (100.9 KB - PDF)
íslenska (IS) (110.34 KB - PDF)
italiano (IT) (110.69 KB - PDF)
latviešu valoda (LV) (107.83 KB - PDF)
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magyar (HU) (105.6 KB - PDF)
Malti (MT) (110.7 KB - PDF)
Nederlands (NL) (111.7 KB - PDF)
norsk (NO) (95.35 KB - PDF)
polski (PL) (110.54 KB - PDF)
português (PT) (105.39 KB - PDF)
română (RO) (103.65 KB - PDF)
slovenčina (SK) (109.82 KB - PDF)
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