EMEA-001039-PIP01-10-M02 - 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
• Decision number:
  P/0157/2016
• PIP number:
  EMEA-001039-PIP01-10-M02
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  • Treatment of dystonia
  • Treatment of muscle spasticity
  • Treatment of muscle-induced wrinkles
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/06/2016
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001039-PIP01-10-M02
• Compliance opinion date:
  15/12/2017
• Compliance outcome:
  Positive

Decision

P/0157/2016: EMA decision of 15 June 2016 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, Bocoutur...

Adopted Reference Number: EMA/314183/2016