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
- Verapamil
- Procedure number
- PSUSA/00003105/202001
- Regulatory outcome
- Variation
Documents
Verapamil: List of nationally authorised medicinal products - PSUSA/00003105/202001
English (EN) (171.96 KB - PDF)
Verapamil: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003105/202001
English (EN) (63.26 KB - PDF)
български (BG) (106.65 KB - PDF)
español (ES) (23.53 KB - PDF)
čeština (CS) (94.18 KB - PDF)
dansk (DA) (28.68 KB - PDF)
Deutsch (DE) (137.53 KB - PDF)
eesti keel (ET) (28.12 KB - PDF)
ελληνικά (EL) (84.96 KB - PDF)
français (FR) (26.8 KB - PDF)
hrvatski (HR) (93.32 KB - PDF)
íslenska (IS) (27.28 KB - PDF)
italiano (IT) (30.77 KB - PDF)
latviešu valoda (LV) (87.22 KB - PDF)
lietuvių kalba (LT) (94.3 KB - PDF)
magyar (HU) (212.32 KB - PDF)
Malti (MT) (104.07 KB - PDF)
Nederlands (NL) (27.89 KB - PDF)
norsk (NO) (36 KB - PDF)
polski (PL) (93.49 KB - PDF)
português (PT) (24.2 KB - PDF)
română (RO) (94.37 KB - PDF)
slovenčina (SK) (97.85 KB - PDF)
slovenščina (SL) (94.08 KB - PDF)
Suomi (FI) (23.12 KB - PDF)
svenska (SV) (22.93 KB - PDF)