EMEA-001811-PIP04-21 - paediatric investigation plan

ligelizumab

Key facts

• Active substance:
  ligelizumab
• Therapeutic area:
  Dermatology
• Decision number:
  P/0355/2021
• PIP number:
  EMEA-001811-PIP04-21
• Pharmaceutical form(s):
  • Solution for injection
  • Age appropriate dosage form for parenteral use
• Condition(s) / indication(s):
  Treatment of chronic inducible urticaria
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/09/2021
• Compliance check done:
  No

Decision

P/0355/2021 : EMA decision of 8 September 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ligelizumab (EMEA-001811-PIP04-21)

Adopted Reference Number: EMA/463911/2021