EMEA-001039-PIP03-17 - 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/0338/2018
• PIP number:
  EMEA-001039-PIP03-17
• Pharmaceutical form(s):
  • Powder for solution for injection
  • Solution for injection in pre-filled syringe
• Condition(s) / indication(s):
  Treatment of hemifacial spasm
• Route(s) of administration:
  Intramuscular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/10/2018

Decision

P/0338/2018: EMA decision of 12 October 2018 on the review of a granted waiver for clostridium botulinum neurotoxin type A (150 kD), free from complexing proteins (Xeomin, Bocouture), (EMEA-001039-PIP03-17)

AdoptedReference Number: EMA/693805/2018