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
- Procedure number
- PSUSA/00002174/201802
- Regulatory outcome
- Variation
Documents
Nitrofurantoin, nifurtoinol: List of nationally authorised medicinal products - PSUSA/00002174/201802
English (EN) (72.13 KB - PDF)
Nitrofurantoin, nifurtoinol: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002174/201802
English (EN) (37.11 KB - PDF)
български (BG) (93.41 KB - PDF)
español (ES) (39.27 KB - PDF)
čeština (CS) (77.45 KB - PDF)
dansk (DA) (29.81 KB - PDF)
Deutsch (DE) (30.45 KB - PDF)
eesti keel (ET) (29.28 KB - PDF)
ελληνικά (EL) (71.65 KB - PDF)
français (FR) (30.77 KB - PDF)
hrvatski (HR) (68.56 KB - PDF)
Gaeilge (GA) (28.6 KB - PDF)
italiano (IT) (30.38 KB - PDF)
latviešu valoda (LV) (73.35 KB - PDF)
lietuvių kalba (LT) (99.35 KB - PDF)
magyar (HU) (57.59 KB - PDF)
Malti (MT) (60.92 KB - PDF)
Nederlands (NL) (31.55 KB - PDF)
norsk (NO) (29.82 KB - PDF)
polski (PL) (74.14 KB - PDF)
português (PT) (29.89 KB - PDF)
română (RO) (68.59 KB - PDF)
slovenčina (SK) (73.42 KB - PDF)
slovenščina (SL) (64.84 KB - PDF)
Suomi (FI) (29.91 KB - PDF)
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