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
- Sumatriptan
- Procedure number
- PSUSA/00002832/201909
- Regulatory outcome
- Variation
Documents
Sumatriptan : List of nationally authorised medicinal products - PSUSA/00002832/201909
English (EN) (241.22 KB - PDF)
Sumatriptan : CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002832/201909
English (EN) (119.76 KB - PDF)
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español (ES) (166.99 KB - PDF)
čeština (CS) (156.14 KB - PDF)
dansk (DA) (132.24 KB - PDF)
Deutsch (DE) (42.16 KB - PDF)
eesti keel (ET) (162.88 KB - PDF)
ελληνικά (EL) (186.26 KB - PDF)
français (FR) (126.85 KB - PDF)
hrvatski (HR) (101.41 KB - PDF)
íslenska (IS) (41.92 KB - PDF)
italiano (IT) (123.01 KB - PDF)
latviešu valoda (LV) (136.75 KB - PDF)
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magyar (HU) (106.29 KB - PDF)
Malti (MT) (160.58 KB - PDF)
Nederlands (NL) (58.17 KB - PDF)
norsk (NO) (142.65 KB - PDF)
polski (PL) (138.13 KB - PDF)
português (PT) (157.57 KB - PDF)
română (RO) (123.92 KB - PDF)
slovenčina (SK) (127.54 KB - PDF)
slovenščina (SL) (141.29 KB - PDF)
Suomi (FI) (138.19 KB - PDF)
svenska (SV) (159.42 KB - PDF)