PSUSA/00010236/202001 - periodic safety update report single assessment
iron
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
- iron
- Procedure number
- PSUSA/00010236/202001
- Regulatory outcome
- Variation
Documents
Iron (parenteral preparations, except for iron dextran): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010236/202001
English (EN) (27.64 KB - PDF)
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български (BG) (76.13 KB - PDF)
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07/09/2020
español (ES) (28.52 KB - PDF)
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07/09/2020
čeština (CS) (59.24 KB - PDF)
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07/09/2020
dansk (DA) (27.87 KB - PDF)
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07/09/2020
Deutsch (DE) (29.5 KB - PDF)
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07/09/2020
eesti keel (ET) (27.8 KB - PDF)
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07/09/2020
ελληνικά (EL) (132.29 KB - PDF)
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07/09/2020
français (FR) (28.65 KB - PDF)
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07/09/2020
hrvatski (HR) (65.09 KB - PDF)
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07/09/2020
íslenska (IS) (27.78 KB - PDF)
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07/09/2020
italiano (IT) (28.84 KB - PDF)
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07/09/2020
latviešu valoda (LV) (81.43 KB - PDF)
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07/09/2020
lietuvių kalba (LT) (74.33 KB - PDF)
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07/09/2020
magyar (HU) (57.1 KB - PDF)
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07/09/2020
Malti (MT) (70.47 KB - PDF)
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07/09/2020
Nederlands (NL) (28.21 KB - PDF)
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07/09/2020
norsk (NO) (28.4 KB - PDF)
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07/09/2020
polski (PL) (61.32 KB - PDF)
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07/09/2020
português (PT) (28.01 KB - PDF)
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07/09/2020
română (RO) (66.42 KB - PDF)
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07/09/2020
slovenčina (SK) (58.98 KB - PDF)
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07/09/2020
slovenščina (SL) (65.5 KB - PDF)
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07/09/2020
Suomi (FI) (26.7 KB - PDF)
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07/09/2020
svenska (SV) (27.31 KB - PDF)
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07/09/2020
Iron (parenteral preparations, except for iron dextran): List of nationally authorised medicinal products - PSUSA/00010236/202001
Reference Number: EMA/270645/2015
English (EN) (328.79 KB - PDF)
First published: