EMEA-002438-PIP04-23 - paediatric investigation plan

rilzabrutinib

Key facts

• Active substance:
  rilzabrutinib
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0288/2023
• PIP number:
  EMEA-002438-PIP04-23
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of autoimmune haemolytic aneamia
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/08/2023
• Compliance check done:
  No

Decision

P/0288/2023 : EMA decision of 4 August 2023 on the granting of a product specific waiver for rilzabrutinib (EMEA-002438-PIP04-23)

Reference Number: EMA/335235/2023