PSUSA/00001450/202211 - periodic safety update report single assessment
Flurbiprofen
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
- Flurbiprofen
- Procedure number
- PSUSA/00001450/202211
- Regulatory outcome
- Variation
Documents
Flurbiprofen : List of nationally authorised medicinal products - PSUSA/00001450/202211
Reference Number: EMA/384493/2023
English (EN) (672.79 KB - PDF)
First published:
Flurbiprofen : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001450/202211
English (EN) (126.03 KB - PDF)
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български (BG) (254.38 KB - PDF)
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05/09/2023
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08/09/2023
español (ES) (202.41 KB - PDF)
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05/09/2023
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čeština (CS) (216.04 KB - PDF)
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dansk (DA) (200.15 KB - PDF)
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Deutsch (DE) (157.09 KB - PDF)
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eesti keel (ET) (88.01 KB - PDF)
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ελληνικά (EL) (226.31 KB - PDF)
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français (FR) (185.62 KB - PDF)
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hrvatski (HR) (260.5 KB - PDF)
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íslenska (IS) (181.4 KB - PDF)
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italiano (IT) (223.78 KB - PDF)
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latviešu valoda (LV) (215.31 KB - PDF)
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lietuvių kalba (LT) (198.09 KB - PDF)
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magyar (HU) (302.5 KB - PDF)
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Nederlands (NL) (171.96 KB - PDF)
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norsk (NO) (201.26 KB - PDF)
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polski (PL) (129 KB - PDF)
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português (PT) (164.03 KB - PDF)
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română (RO) (262.63 KB - PDF)
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slovenčina (SK) (115.81 KB - PDF)
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slovenščina (SL) (256.54 KB - PDF)
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Suomi (FI) (152.03 KB - PDF)
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svenska (SV) (161.69 KB - PDF)
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Last updated:
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