EMEA-001143-PIP01-11-M06 - paediatric investigation plan

cabozantinib

Key facts

• Invented name:
  • Cometriq
  • Cabometyx
• Active Substance:
  cabozantinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0309/2023
• PIP number:
  EMEA-001143-PIP01-11-M06
• Pharmaceutical form(s):
  • Film-coated tablet
  • Capsule, hard
• Condition(s) / indication(s):
  Treatment of solid malignant tumours
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Ipsen Pharma

  E-mail: [e-mail]; Tel.: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  07/08/2023

Decision

P/0309/2023 : EMA decision of 7 August on the acceptance of a modification of an agreed paediatric investigation plan for cabozantinib (Cometriq, Cabometyx), (EMEA-001143-PIP01-11-M06)

Reference Number: EMA/344395/2023