EMEA-001143-PIP01-11-M04 - paediatric investigation plan

cabozantinib

Key facts

• Invented name:
  • Cometriq
  • Cabometyx
• Active Substance:
  cabozantinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0357/2022
• PIP number:
  EMEA-001143-PIP01-11-M04
• Pharmaceutical form(s):
  • Age-appropriate oral solid dosage form
  • 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:
  11/08/2022

Decision

P/0357/2022 : EMA decision of 11 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cabozantinib (Cometriq, Cabometyx), (EMEA-001143-PIP01-11-M05)

AdoptedReference Number: EMA/681946/2022