EMEA-002358-PIP02-18-M04 - paediatric investigation plan

avapritinib

Key facts

• Invented name:
  Ayvakyt
• Active substance:
  avapritinib
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0363/2024
• PIP number:
  EMEA-002358-PIP02-18-M04
• 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:
  25/10/2024
• Compliance check done:
  No

Decision

P/0363/2024: EMA decision of 25 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for avapritinib (Ayvakyt), (EMEA-002358-PIP02-18-M04)

Adopted Reference Number: EMA/466009/2024