PSUSA/00001783/202005 - periodic safety update report single assessment
Irinotecan (except for liposomal formulations)
PSUSAHuman
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
- Irinotecan (except for liposomal formulations)
- Procedure number
- PSUSA/00001783/202005
- Regulatory outcome
- Variation
Documents
Irinotecan (except for liposomal formulations): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001783/202005
English (EN) (108.72 KB - PDF)
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български (BG) (117.43 KB - PDF)
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15/03/2021
español (ES) (114.19 KB - PDF)
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15/03/2021
čeština (CS) (115.87 KB - PDF)
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15/03/2021
dansk (DA) (111.88 KB - PDF)
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15/03/2021
Deutsch (DE) (117 KB - PDF)
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15/03/2021
eesti keel (ET) (104.88 KB - PDF)
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15/03/2021
ελληνικά (EL) (117.23 KB - PDF)
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15/03/2021
français (FR) (110.04 KB - PDF)
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15/03/2021
hrvatski (HR) (116.63 KB - PDF)
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15/03/2021
íslenska (IS) (115.78 KB - PDF)
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15/03/2021
italiano (IT) (121.06 KB - PDF)
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15/03/2021
latviešu valoda (LV) (119.01 KB - PDF)
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15/03/2021
lietuvių kalba (LT) (117.38 KB - PDF)
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15/03/2021
magyar (HU) (115.85 KB - PDF)
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15/03/2021
Malti (MT) (120.27 KB - PDF)
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15/03/2021
Nederlands (NL) (116.92 KB - PDF)
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15/03/2021
norsk (NO) (111.22 KB - PDF)
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15/03/2021
polski (PL) (115.82 KB - PDF)
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15/03/2021
português (PT) (113.34 KB - PDF)
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15/03/2021
română (RO) (113.25 KB - PDF)
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15/03/2021
slovenčina (SK) (117.78 KB - PDF)
First published:
15/03/2021
slovenščina (SL) (115.53 KB - PDF)
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15/03/2021
Suomi (FI) (107.84 KB - PDF)
First published:
15/03/2021
svenska (SV) (112.04 KB - PDF)
First published:
15/03/2021
Irinotecan (except for liposomal formulations): List of nationally authorised medicinal products - PSUSA/00001783/202005
Reference Number: EMA/150667/2021
English (EN) (175.17 KB - PDF)
First published: