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
- Diclofenac
- Procedure number
- PSUSA/00001048/202109
- Regulatory outcome
- Variation
Documents
Diclofenac (systemic formulations) : List of nationally authorised medicinal products - PSUSA/00001048/202109
English (EN) (605.95 KB - PDF)
Diclofenac (systemic formulations) : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00001048/202109
English (EN) (130.68 KB - PDF)
български (BG) (150.99 KB - PDF)
español (ES) (132.78 KB - PDF)
čeština (CS) (170.32 KB - PDF)
dansk (DA) (123.31 KB - PDF)
Deutsch (DE) (128.04 KB - PDF)
eesti keel (ET) (121.81 KB - PDF)
ελληνικά (EL) (136.41 KB - PDF)
français (FR) (138.36 KB - PDF)
hrvatski (HR) (153.41 KB - PDF)
íslenska (IS) (137.76 KB - PDF)
italiano (IT) (171.11 KB - PDF)
latviešu valoda (LV) (174.83 KB - PDF)
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magyar (HU) (150.82 KB - PDF)
Malti (MT) (143.1 KB - PDF)
Nederlands (NL) (114.2 KB - PDF)
norsk (NO) (200.84 KB - PDF)
polski (PL) (155.97 KB - PDF)
português (PT) (123.92 KB - PDF)
română (RO) (133.34 KB - PDF)
slovenčina (SK) (135.09 KB - PDF)
slovenščina (SL) (151.41 KB - PDF)
Suomi (FI) (111.8 KB - PDF)
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