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
- Diltiazem
- Procedure number
- PSUSA/00001084/202205
- Regulatory outcome
- Variation
Documents
Diltiazem - List of nationally authorised medicinal products - PSUSA/00001084/202205
English (EN) (384.17 KB - PDF)
Diltiazem - CMDh Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA/00001084/202205
English (EN) (115.73 KB - PDF)
български (BG) (252.02 KB - PDF)
español (ES) (198.75 KB - PDF)
čeština (CS) (132.9 KB - PDF)
dansk (DA) (200.08 KB - PDF)
Deutsch (DE) (145.18 KB - PDF)
eesti keel (ET) (54.47 KB - PDF)
ελληνικά (EL) (128.4 KB - PDF)
français (FR) (112.08 KB - PDF)
hrvatski (HR) (157.38 KB - PDF)
íslenska (IS) (143.47 KB - PDF)
italiano (IT) (200.5 KB - PDF)
latviešu valoda (LV) (132.05 KB - PDF)
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magyar (HU) (59.49 KB - PDF)
Malti (MT) (241.65 KB - PDF)
Nederlands (NL) (128.07 KB - PDF)
norsk (NO) (99.24 KB - PDF)
polski (PL) (221.08 KB - PDF)
português (PT) (189.86 KB - PDF)
română (RO) (220.28 KB - PDF)
slovenčina (SK) (111.97 KB - PDF)
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Suomi (FI) (168.84 KB - PDF)
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