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
- Teicoplanin
- Procedure number
- PSUSA/00002878/202111
- Regulatory outcome
- Variation
Documents
teicoplanin : List of nationally authorised medicinal products - PSUSA/00002878/202111
English (EN) (318.51 KB - PDF)
Teicoplanin : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00002878/202111
English (EN) (121.18 KB - PDF)
български (BG) (169.48 KB - PDF)
español (ES) (185.92 KB - PDF)
čeština (CS) (50.65 KB - PDF)
dansk (DA) (86.37 KB - PDF)
Deutsch (DE) (79.17 KB - PDF)
eesti keel (ET) (120.26 KB - PDF)
ελληνικά (EL) (185.73 KB - PDF)
français (FR) (85.44 KB - PDF)
hrvatski (HR) (138.6 KB - PDF)
Gaeilge (GA) (121.81 KB - PDF)
italiano (IT) (178.51 KB - PDF)
latviešu valoda (LV) (155.42 KB - PDF)
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magyar (HU) (208.89 KB - PDF)
Malti (MT) (146.99 KB - PDF)
Nederlands (NL) (67.47 KB - PDF)
polski (PL) (129.04 KB - PDF)
português (PT) (136.39 KB - PDF)
română (RO) (224.88 KB - PDF)
slovenčina (SK) (182.35 KB - PDF)
slovenščina (SL) (70.41 KB - PDF)
Suomi (FI) (45.94 KB - PDF)
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