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
- Loperamide, loperamide / simeticone
- Procedure number
- PSUSA/00010665/202105
- Regulatory outcome
- Variation
Documents
Loperamide, loperamide / simeticone : List of nationally authorised medicinal products - PSUSA/00010665/202105
English (EN) (228.94 KB - PDF)
Loperamide, loperamide / simeticone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010665/202105
English (EN) (27.38 KB - PDF)
български (BG) (53.31 KB - PDF)
español (ES) (25.91 KB - PDF)
čeština (CS) (48.33 KB - PDF)
dansk (DA) (25.34 KB - PDF)
Deutsch (DE) (25.76 KB - PDF)
eesti keel (ET) (24.72 KB - PDF)
ελληνικά (EL) (54.96 KB - PDF)
français (FR) (25.91 KB - PDF)
hrvatski (HR) (47.29 KB - PDF)
íslenska (IS) (25.02 KB - PDF)
italiano (IT) (27.51 KB - PDF)
latviešu valoda (LV) (50.9 KB - PDF)
lietuvių kalba (LT) (76.61 KB - PDF)
magyar (HU) (45.65 KB - PDF)
Malti (MT) (51.45 KB - PDF)
Nederlands (NL) (25.97 KB - PDF)
norsk (NO) (25.04 KB - PDF)
polski (PL) (50.44 KB - PDF)
português (PT) (25.53 KB - PDF)
română (RO) (48.47 KB - PDF)
slovenčina (SK) (47.81 KB - PDF)
slovenščina (SL) (45.82 KB - PDF)
Suomi (FI) (24.87 KB - PDF)
svenska (SV) (25.28 KB - PDF)