EMEA-001039-PIP04-23 - paediatric investigation plan

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

Key facts

• Invented name:
  • Bocouture
  • Xeomin
• Active Substance:
  Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0136/2024
• PIP number:
  EMEA-001039-PIP04-23
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of essential tremor
• Route(s) of administration:
  • Intramuscular use
  • Intraglandular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  06/05/2024

Decision

P/0136/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for clostridium botulinum neurotoxin type A (150 kD), free from complexing proteins (Xeomin, Bocouture), (EMEA-001039-PIP04-23)

Reference Number: EMA/153118/2024