EMEA-003445-PIP01-23 - paediatric investigation plan

bezuclastinib

Key facts

• Active substance:
  bezuclastinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0395/2023
• PIP number:
  EMEA-003445-PIP01-23
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of mastocytosis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  06/10/2023
• Compliance check done:
  No

Decision

P/0395/2023 : EMA decision of 6 October 2023 on the granting of a product specific waiver for bezuclastinib (EMEA-003445-PIP01-23)

Adopted Reference Number: EMA/401516/2023