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
- allopurinol
- Procedure number
- PSUSA/00000095/202012
- Regulatory outcome
- Variation
Documents
Allopurinol : List of nationally authorised medicinal products - PSUSA/00000095/202012
English (EN) (263.31 KB - PDF)
Allopurinol : CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000095/202012
English (EN) (102.98 KB - PDF)
български (BG) (135.67 KB - PDF)
español (ES) (123.92 KB - PDF)
čeština (CS) (117.64 KB - PDF)
dansk (DA) (162.65 KB - PDF)
Deutsch (DE) (107.99 KB - PDF)
eesti keel (ET) (156.37 KB - PDF)
ελληνικά (EL) (121.96 KB - PDF)
français (FR) (117.07 KB - PDF)
hrvatski (HR) (216.32 KB - PDF)
íslenska (IS) (107.49 KB - PDF)
italiano (IT) (99.17 KB - PDF)
latviešu valoda (LV) (198.02 KB - PDF)
lietuvių kalba (LT) (211.28 KB - PDF)
magyar (HU) (123.41 KB - PDF)
Malti (MT) (208.46 KB - PDF)
Nederlands (NL) (127.05 KB - PDF)
norsk (NO) (104.06 KB - PDF)
polski (PL) (118.82 KB - PDF)
português (PT) (106.66 KB - PDF)
română (RO) (221.58 KB - PDF)
slovenčina (SK) (109.5 KB - PDF)
slovenščina (SL) (125.85 KB - PDF)
Suomi (FI) (91.77 KB - PDF)
svenska (SV) (123.85 KB - PDF)