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
- Leuprorelin
- Procedure number
- PSUSA/00001844/201707
Documents
Leuprorelin: List of nationally authorised medicinal products - PSUSA/00001844/201707
English (EN) (482.37 KB - PDF)
Leuprorelin: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001844/201707
English (EN) (31.71 KB - PDF)
български (BG) (99.03 KB - PDF)
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čeština (CS) (121.91 KB - PDF)
dansk (DA) (36.42 KB - PDF)
Deutsch (DE) (31.31 KB - PDF)
eesti keel (ET) (36.2 KB - PDF)
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français (FR) (35.75 KB - PDF)
hrvatski (HR) (93.95 KB - PDF)
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italiano (IT) (38.66 KB - PDF)
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polski (PL) (95.31 KB - PDF)
português (PT) (32.58 KB - PDF)
română (RO) (100.31 KB - PDF)
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