PSUSA/00001450/202211 - periodic safety update report single assessment
Flurbiprofen
PSUSAHuman
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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
Last updated:
08/09/2023
español (ES) (202.41 KB - PDF)
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05/09/2023
Last updated:
08/09/2023
čeština (CS) (216.04 KB - PDF)
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05/09/2023
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08/09/2023
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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08/09/2023
français (FR) (185.62 KB - PDF)
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05/09/2023
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08/09/2023
hrvatski (HR) (260.5 KB - PDF)
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05/09/2023
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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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05/09/2023
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08/09/2023
lietuvių kalba (LT) (198.09 KB - PDF)
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magyar (HU) (302.5 KB - PDF)
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05/09/2023
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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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05/09/2023
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08/09/2023
português (PT) (164.03 KB - PDF)
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05/09/2023
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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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05/09/2023
Last updated:
08/09/2023
svenska (SV) (161.69 KB - PDF)
First published:
05/09/2023
Last updated:
08/09/2023