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
- pravastatin
- Procedure number
- PSUSA/00002500/202303
- Regulatory outcome
- Variation
Documents
Pravastatin : List of nationally authorised medicinal products - PSUSA/00002500/202303
English (EN) (238.73 KB - PDF)
Pravastatin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002500/202303
English (EN) (107.04 KB - PDF)
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čeština (CS) (139.31 KB - PDF)
dansk (DA) (106.88 KB - PDF)
Deutsch (DE) (110.69 KB - PDF)
eesti keel (ET) (105.16 KB - PDF)
ελληνικά (EL) (125.35 KB - PDF)
français (FR) (105.79 KB - PDF)
hrvatski (HR) (213.57 KB - PDF)
italiano (IT) (107.58 KB - PDF)
latviešu valoda (LV) (143.36 KB - PDF)
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magyar (HU) (138.09 KB - PDF)
Malti (MT) (126 KB - PDF)
Nederlands (NL) (108.09 KB - PDF)
norsk (NO) (106.83 KB - PDF)
polski (PL) (135.19 KB - PDF)
português (PT) (107.8 KB - PDF)
română (RO) (124.79 KB - PDF)
slovenčina (SK) (129.16 KB - PDF)
slovenščina (SL) (133.75 KB - PDF)
Suomi (FI) (104.09 KB - PDF)
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