PSUSA/00001392/201608 - periodic safety update report single assessment
Finasteride
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
- Finasteride
- Procedure number
- PSUSA/00001392/201608
- Regulatory outcome
- Variation
Documents
Finasteride : List of nationally authorised medicinal products - PSUSA/00001392/201608
Reference Number: EMA/344631/2017
English (EN) (127.29 KB - PDF)
First published:
Last updated:
Finasteride : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001392/201608
English (EN) (114.63 KB - PDF)
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Last updated:
български (BG) (127.59 KB - PDF)
First published:
30/05/2017
Last updated:
30/05/2017
español (ES) (115.81 KB - PDF)
First published:
30/05/2017
Last updated:
30/05/2017
čeština (CS) (126.3 KB - PDF)
First published:
30/05/2017
Last updated:
30/05/2017
dansk (DA) (119.13 KB - PDF)
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30/05/2017
Last updated:
30/05/2017
Deutsch (DE) (129.52 KB - PDF)
First published:
30/05/2017
Last updated:
30/05/2017
eesti keel (ET) (114.92 KB - PDF)
First published:
30/05/2017
Last updated:
30/05/2017
ελληνικά (EL) (137.22 KB - PDF)
First published:
30/05/2017
Last updated:
30/05/2017
français (FR) (129.03 KB - PDF)
First published:
30/05/2017
Last updated:
30/05/2017
hrvatski (HR) (127.55 KB - PDF)
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30/05/2017
Last updated:
30/05/2017
íslenska (IS) (120.25 KB - PDF)
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30/05/2017
Last updated:
30/05/2017
italiano (IT) (136.96 KB - PDF)
First published:
30/05/2017
Last updated:
30/05/2017
latviešu valoda (LV) (141.32 KB - PDF)
First published:
30/05/2017
Last updated:
30/05/2017
lietuvių kalba (LT) (129.05 KB - PDF)
First published:
30/05/2017
Last updated:
30/05/2017
magyar (HU) (118.86 KB - PDF)
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30/05/2017
Last updated:
30/05/2017
Malti (MT) (135 KB - PDF)
First published:
30/05/2017
Last updated:
30/05/2017
Nederlands (NL) (128.31 KB - PDF)
First published:
30/05/2017
Last updated:
30/05/2017
norsk (NO) (121.84 KB - PDF)
First published:
30/05/2017
Last updated:
30/05/2017
polski (PL) (126.33 KB - PDF)
First published:
30/05/2017
Last updated:
30/05/2017
português (PT) (134.17 KB - PDF)
First published:
30/05/2017
Last updated:
30/05/2017
română (RO) (117.51 KB - PDF)
First published:
30/05/2017
Last updated:
30/05/2017
slovenčina (SK) (109.85 KB - PDF)
First published:
30/05/2017
Last updated:
30/05/2017
slovenščina (SL) (121.64 KB - PDF)
First published:
30/05/2017
Last updated:
30/05/2017
Suomi (FI) (120.25 KB - PDF)
First published:
30/05/2017
Last updated:
30/05/2017
svenska (SV) (119.1 KB - PDF)
First published:
30/05/2017
Last updated:
30/05/2017