EMA/PE/0000232758 - paediatric investigation plan

remibrutinib

Key facts

• Active substance:
  remibrutinib
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000232758
• PIP number:
  EMA/PE/0000232758
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of myasthenia gravis
• 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:
  14/04/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000232758: EMA decision of 14 April 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for remibrutinib

Adopted Reference Number: EMADOC-1700519818-2034703