EMEA-002438-PIP02-19-M03 - paediatric investigation plan

rilzabrutinib

Key facts

• Active substance:
  rilzabrutinib
• Therapeutic area:
  Immune system disorders
• Decision number:
  P/0524/2023
• PIP number:
  EMEA-002438-PIP02-19-M03
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of immune thrombocytopenia
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/12/2023
• Compliance check done:
  No

Decision

P/0524/2023 : EMA decision of 29 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for rilzabrutinib (EMEA- 002438-PIP02-19-M03)

Reference Number: EMA/553384/2023