EMEA-002582-PIP01-19-M03 - paediatric investigation plan

Remibrutinib

Key facts

• Active Substance:
  Remibrutinib
• Therapeutic area:
  Dermatology
• Decision number:
  P/0453/2023
• PIP number:
  EMEA-002582-PIP01-19-M03
• Pharmaceutical form(s):
  • Age-appropriate oral solid dosage form
  • Coated tablet
• Condition(s) / indication(s):
  Treatment of chronic spontaneous urticaria
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/11/2023

Decision

P/0453/2023 EMA decision of of 13 November 2023 on the acceptance of a modification of an agreed paediatric investigation plan for remibrutinib (EMEA- 002582-PIP01-19-M03)

AdoptedReference Number: EMA/486074/2023