EMA/PE/0000181294 - paediatric investigation plan

Tolebrutinib

Key facts

• Active substance:
  Tolebrutinib
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0019/2024
• PIP number:
  EMA/PE/0000181294
• 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:
  06/12/2024
• Compliance check done:
  No

Decision

EMA/PE/0000181294: EMA decision of 6 December 2024 on the acceptance of a modification of an agreed paediatric investigation plan for tolebrutinib

Adopted Reference Number: EMADOC-1700519818-1766802