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

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

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

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