EMA/PE/0000227963 - paediatric investigation plan

catequentinib (dihydrochloride)

Key facts

• Active substance:
  catequentinib (dihydrochloride)
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0110/2024
• PIP number:
  EMA/PE/0000227963
• Pharmaceutical form(s):
  • Capsule, hard
  • Age-appropriate oral dosage formulation
• Condition(s) / indication(s):
  • Treatment of Ewing sarcoma
  • Treatment of soft tissue sarcoma
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/03/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000227963: EMA decision of 21 March 2025 on the acceptance of a modification of an agreed paediatric investigation plan for catequentinib (dihydrochloride)

Adopted Reference Number: EMADOC-1700519818-1976180