PSUSA/00009084/201812 - periodic safety update report single assessment

Botulinum neurotoxin type a (150 kd) free from complexing proteins

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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

Documentos

Botulinum neurotoxin type a (150 kD) free from complexing proteins: List of nationally authorised medicinal products - PSUSA/00009084/201812

Reference Number: EMA/583348/2019

Botulinum neurotoxin type a (150 kD) free from complexing proteins: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00009084/201812