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
- Ibuprofen / levomenthol
- Procedure number
- PSUSA/00001708/202007
- Regulatory outcome
- Variation
Documents
Ibuprofen / levomenthol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001708/202007
English (EN) (87.19 KB - PDF)
български (BG) (113.6 KB - PDF)
español (ES) (87.6 KB - PDF)
čeština (CS) (78.91 KB - PDF)
dansk (DA) (120.43 KB - PDF)
Deutsch (DE) (91.77 KB - PDF)
eesti keel (ET) (130.83 KB - PDF)
ελληνικά (EL) (110.72 KB - PDF)
français (FR) (74.94 KB - PDF)
hrvatski (HR) (112.34 KB - PDF)
íslenska (IS) (86.16 KB - PDF)
italiano (IT) (101.53 KB - PDF)
latviešu valoda (LV) (116.5 KB - PDF)
lietuvių kalba (LT) (105.87 KB - PDF)
magyar (HU) (120.66 KB - PDF)
Malti (MT) (117.16 KB - PDF)
Nederlands (NL) (72.59 KB - PDF)
norsk (NO) (87.12 KB - PDF)
polski (PL) (81.26 KB - PDF)
português (PT) (87.91 KB - PDF)
română (RO) (115.82 KB - PDF)
slovenčina (SK) (81.03 KB - PDF)
slovenščina (SL) (113.79 KB - PDF)
Suomi (FI) (83.88 KB - PDF)
svenska (SV) (86.53 KB - PDF)
Ibuprofen / levomenthol: List of nationally authorised medicinal products - PSUSA/00001708/202007
English (EN) (126.99 KB - PDF)