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
- Meloxicam
- Procedure number
- PSUSA/00010474/202207
- Regulatory outcome
- Variation
Documents
Meloxicam : List of nationally authorised medicinal products - PSUSA/00010474/202207
English (EN) (303.26 KB - PDF)
Meloxicam : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010474/202207
English (EN) (107.15 KB - PDF)
български (BG) (154.79 KB - PDF)
español (ES) (113.23 KB - PDF)
čeština (CS) (102.38 KB - PDF)
dansk (DA) (94.87 KB - PDF)
Deutsch (DE) (278.26 KB - PDF)
eesti keel (ET) (100.02 KB - PDF)
ελληνικά (EL) (102.46 KB - PDF)
français (FR) (109.21 KB - PDF)
hrvatski (HR) (130.17 KB - PDF)
italiano (IT) (146.2 KB - PDF)
latviešu valoda (LV) (138.79 KB - PDF)
lietuvių kalba (LT) (132.18 KB - PDF)
magyar (HU) (202.34 KB - PDF)
Malti (MT) (100.39 KB - PDF)
Nederlands (NL) (102.46 KB - PDF)
polski (PL) (139.04 KB - PDF)
português (PT) (93.35 KB - PDF)
română (RO) (110.4 KB - PDF)
slovenčina (SK) (159.61 KB - PDF)
slovenščina (SL) (108.39 KB - PDF)
Suomi (FI) (121.7 KB - PDF)
svenska (SV) (93.93 KB - PDF)