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
- amiodarone
- Procedure number
- PSUSA/00000166/202012
- Regulatory outcome
- Variation
Documents
Amiodarone - List of nationally authorised medicinal products - PSUSA-00000166-202012
English (EN) (203.01 KB - PDF)
Amiodarone - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00000166-202012
English (EN) (138.74 KB - PDF)
български (BG) (85.5 KB - PDF)
español (ES) (98.1 KB - PDF)
čeština (CS) (74.34 KB - PDF)
dansk (DA) (180.25 KB - PDF)
Deutsch (DE) (191.26 KB - PDF)
eesti keel (ET) (176.74 KB - PDF)
ελληνικά (EL) (192.33 KB - PDF)
français (FR) (140.63 KB - PDF)
hrvatski (HR) (182.38 KB - PDF)
íslenska (IS) (101.54 KB - PDF)
italiano (IT) (212.4 KB - PDF)
latviešu valoda (LV) (225.9 KB - PDF)
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magyar (HU) (42.85 KB - PDF)
Malti (MT) (172.25 KB - PDF)
Nederlands (NL) (130.79 KB - PDF)
norsk (NO) (169.55 KB - PDF)
polski (PL) (143.69 KB - PDF)
português (PT) (175.5 KB - PDF)
română (RO) (235.52 KB - PDF)
slovenčina (SK) (151.28 KB - PDF)
slovenščina (SL) (108.7 KB - PDF)
Suomi (FI) (97.1 KB - PDF)
svenska (SV) (188.08 KB - PDF)