PSUSA/00009084/201812 - periodic safety update report single assessment
Botulinum neurotoxin type a (150 kd) free from complexing proteins
PSUSA
Human
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
- Botulinum neurotoxin type a (150 kd) free from complexing proteins
- Procedure number
- PSUSA/00009084/201812
- Regulatory outcome
- Variation
Documents
Botulinum neurotoxin type a (150 kD) free from complexing proteins: List of nationally authorised medicinal products - PSUSA/00009084/201812
Reference Number: EMA/583348/2019
English (EN) (262.02 KB - PDF)
First published:
Botulinum neurotoxin type a (150 kD) free from complexing proteins: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00009084/201812
English (EN) (27.22 KB - PDF)
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20/01/2020
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