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
- Moxifloxacin (systemic use)
- Procedure number
- PSUSA/00009231/201905
- Regulatory outcome
- Variation
Documents
Moxifloxacin (systemic use): List of nationally authorised medicinal products - PSUSA/00009231/201905
English (EN) (241.13 KB - PDF)
Moxifloxacin (systemic use): CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00009231/201905
English (EN) (90.8 KB - PDF)
български (BG) (211.75 KB - PDF)
español (ES) (73.4 KB - PDF)
čeština (CS) (173.2 KB - PDF)
dansk (DA) (70.32 KB - PDF)
Deutsch (DE) (75.66 KB - PDF)
eesti keel (ET) (98.93 KB - PDF)
ελληνικά (EL) (163.96 KB - PDF)
français (FR) (99.8 KB - PDF)
hrvatski (HR) (173.48 KB - PDF)
íslenska (IS) (94.43 KB - PDF)
italiano (IT) (100.04 KB - PDF)
latviešu valoda (LV) (183.69 KB - PDF)
lietuvių kalba (LT) (182.16 KB - PDF)
magyar (HU) (184.43 KB - PDF)
Malti (MT) (196.97 KB - PDF)
Nederlands (NL) (72.54 KB - PDF)
norsk (NO) (98.81 KB - PDF)
polski (PL) (177.93 KB - PDF)
português (PT) (92.1 KB - PDF)
română (RO) (182.11 KB - PDF)
slovenčina (SK) (186.41 KB - PDF)
slovenščina (SL) (200.87 KB - PDF)
Suomi (FI) (97.33 KB - PDF)
svenska (SV) (94.9 KB - PDF)