EMEA-002358-PIP02-18-M03 - paediatric investigation plan

avapritinib

Key facts

• Invented name:
  Ayvakyt
• Active substance:
  avapritinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0281/2023
• PIP number:
  EMEA-002358-PIP02-18-M03
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/07/2023
• Compliance check done:
  No

Decision

P/0281/2023 : EMA decision of 14 July 2023 on the acceptance of a modification of an agreed paediatric investigation plan for avapritinib (Ayvakyt), (EMEA-002358-PIP02-18-M03)

Reference Number: EMA/315615/2023