EMEA-002582-PIP03-23 - paediatric investigation plan

remibrutinib

Key facts

• Active substance:
  remibrutinib
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0020/2024
• PIP number:
  EMEA-002582-PIP03-23
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of chronic inducible urticaria
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  31/01/2024
• Compliance check done:
  No

Decision

P/0020/2024 : EMA decision of 31 January 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for remibrutinib (EMEA-002582-PIP03-23)

Adopted Reference Number: EMA/25522/2024