EMEA-001811-PIP02-15-M04 - paediatric investigation plan

ligelizumab

Key facts

• Active substance:
  ligelizumab
• Therapeutic area:
  Dermatology
• Decision number:
  P/0308/2021
• PIP number:
  EMEA-001811-PIP02-15-M04
• Pharmaceutical form(s):
  • Solution for injection
  • Age appropriate dosage form for parenteral use
• Condition(s) / indication(s):
  Treatment of chronic spontaneous urticaria
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/08/2021
• Compliance check done:
  No

Decision

P/0308/2021 : EMA decision of 11 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ligelizumab (EMEA-001811-PIP02-15-M04)

Adopted Reference Number: EMA/393809/2021