PSUSA/00001529/202011 - periodic safety update report single assessment
Glatiramer
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
- Glatiramer
- Procedure number
- PSUSA/00001529/202011
- Regulatory outcome
- Variation
Documents
Glatiramer - List of nationally authorised medicinal products - PSUSA-00001529-202011
Adopted
English (EN) (262.84 KB - PDF)
First published:
Glatiramer - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00001529-202011
Adopted
English (EN) (33.83 KB - PDF)
First published:
Last updated:
български (BG) (80.29 KB - PDF)
First published:
06/09/2021
Last updated:
20/01/2022
español (ES) (35.56 KB - PDF)
First published:
06/09/2021
Last updated:
20/01/2022
čeština (CS) (134.01 KB - PDF)
First published:
06/09/2021
Last updated:
20/01/2022
dansk (DA) (34.48 KB - PDF)
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06/09/2021
Last updated:
20/01/2022
Deutsch (DE) (155.78 KB - PDF)
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06/09/2021
Last updated:
20/01/2022
eesti keel (ET) (30.2 KB - PDF)
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06/09/2021
Last updated:
20/01/2022
ελληνικά (EL) (84.1 KB - PDF)
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06/09/2021
Last updated:
20/01/2022
français (FR) (34.28 KB - PDF)
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06/09/2021
Last updated:
20/01/2022
hrvatski (HR) (73.59 KB - PDF)
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06/09/2021
Last updated:
20/01/2022
íslenska (IS) (36.15 KB - PDF)
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06/09/2021
Last updated:
20/01/2022
italiano (IT) (36.54 KB - PDF)
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06/09/2021
Last updated:
20/01/2022
latviešu valoda (LV) (76.32 KB - PDF)
First published:
06/09/2021
Last updated:
20/01/2022
lietuvių kalba (LT) (77.31 KB - PDF)
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06/09/2021
Last updated:
20/01/2022
magyar (HU) (153.76 KB - PDF)
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06/09/2021
Last updated:
20/01/2022
Malti (MT) (78.4 KB - PDF)
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06/09/2021
Last updated:
20/01/2022
Nederlands (NL) (36.33 KB - PDF)
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06/09/2021
Last updated:
20/01/2022
norsk (NO) (30.64 KB - PDF)
First published:
06/09/2021
Last updated:
20/01/2022
polski (PL) (80.05 KB - PDF)
First published:
06/09/2021
Last updated:
20/01/2022
português (PT) (34.25 KB - PDF)
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06/09/2021
Last updated:
20/01/2022
română (RO) (66.96 KB - PDF)
First published:
06/09/2021
Last updated:
20/01/2022
slovenčina (SK) (77.46 KB - PDF)
First published:
06/09/2021
Last updated:
20/01/2022
slovenščina (SL) (66.22 KB - PDF)
First published:
06/09/2021
Last updated:
20/01/2022
Suomi (FI) (86.42 KB - PDF)
First published:
06/09/2021
Last updated:
20/01/2022
svenska (SV) (34.46 KB - PDF)
First published:
06/09/2021
Last updated:
20/01/2022