EMEA-001039-PIP02-12-M04 - paediatric investigation plan

Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins

Key facts

• Invented name:
  • Xeomin
  • Bocouture
• Active substance:
  Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins
• Therapeutic area:
  • Neurology
  • Ophthalmology
• Decision number:
  P/0125/2020
• PIP number:
  EMEA-001039-PIP02-12-M04
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of sialorrhoea
• Route(s) of administration:
  • Intraglandular use
  • Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/03/2020
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001039-PIP02-12-M04
• Compliance opinion date:
  24/07/2020
• Compliance outcome:
  Positive

Decision

P/0125/2020: EMA decision of 30 March 2020 on the acceptance of a modification of an agreed paediatric investigation plan for Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins, (Xeomin, Bocouture), (EMEA-001039-PIP02-12-M04)

Adopted Reference Number: EMA/157768/2020