EMEA-002747-PIP01-20-M01 - paediatric investigation plan

zilucoplan

Key facts

• Invented name:
  Zilbrysq
• Active substance:
  zilucoplan
• Therapeutic area:
  • Neurology
  • Other
• Decision number:
  P/0141/2023
• PIP number:
  EMEA-002747-PIP01-20-M01
• Pharmaceutical form(s):
  • Solution for injection in pre-filled syringe
  • Age appropriate dosage form for parenteral use
• Condition(s) / indication(s):
  Treatment of myasthenia gravis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/04/2023
• Compliance check done:
  Nej

Decision

P/0141/2023 : EMA decision of 14 April 2023 on the acceptance of a modification of an agreed paediatric investigation plan for zilucoplan (EMEA-002747-PIP01-20-M01)

Reference Number: EMA/127821/2023