EMEA-002438-PIP02-19-M02 - paediatric investigation plan

Rilzabrutinib

Key facts

• Active Substance:
  Rilzabrutinib
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0262/2022
• PIP number:
  EMEA-002438-PIP02-19-M02
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of immune thrombocytopenia
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Sanofi B.V.

  E-mail: [e-mail]; Tel. [phone];

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  18/07/2022

Decision

P/062/2022 : EMA decision of 18 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for rilzabrutinib (EMEA- 002438-PIP02-19-M02)

AdoptedReference Number: EMA/624978/2022