EMEA-002486-PIP04-21-M01 - paediatric investigation plan

catequentinib

Key facts

• Active substance:
  catequentinib
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0110/2024
• PIP number:
  EMEA-002486-PIP04-21-M01
• Pharmaceutical form(s):
  • Age appropriate oral liquid dosage formulation
  • Capsule, hard
• Condition(s) / indication(s):
  • Treatment of Ewing sarcoma
  • Treatment of soft tissue sarcomas
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/04/2024
• Compliance check done:
  No

Decision

P/0110/2024: EMA decision of 12 April 2024 on the acceptance of a modification of an agreed paediatric investigation plan for catequentinib, (EMEA-002486-PIP04-21-M01)

Adopted Reference Number: EMA/105462/2024