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
- Ethinylestradiol / levonorgestrel
- Procedure number
- PSUSA/00001309/201904
- Regulatory outcome
- Variation
Documents
Ethinylestradiol / levonorgestrel: List of nationally authorised medicinal products - PSUSA/00001309/201904
English (EN) (208.54 KB - PDF)
Ethinylestradiol / levonorgestrel: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00001309/201904
English (EN) (38.01 KB - PDF)
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italiano (IT) (50.19 KB - PDF)
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polski (PL) (155.93 KB - PDF)
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