EMA/PE/0000245698 - paediatric investigation plan

tolebrutinib

Key facts

• Active substance:
  tolebrutinib
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000245698
• PIP number:
  EMA/PE/0000245698
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of multiple sclerosis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/06/2025
• Compliance check done:
  Nē

Decision

EMA/PE/0000245698 : EMA decision of 13 June 2025 on the acceptance of a modification of an agreed paediatric investigation plan for tolebrutinib

Adopted Reference Number: EMADOC-1700519818-2191796