EMEA-001493-PIP03-18-M01 - paediatric investigation plan

crizotinib

Key facts

• Invented name:
  Xalkori
• Active Substance:
  crizotinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0036/2021
• PIP number:
  EMEA-001493-PIP03-18-M01
• Pharmaceutical form(s):
  • Capsule, hard
  • Age-appropriate oral dosage form
• Condition(s) / indication(s):
  • Treatment of anaplastic large cell lymphoma
  • Treatment of inflammatory myofibroblastic tumours
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  27/01/2021
• Compliance procedure number:
  EMEA-C-001493-PIP03-18-M01
• Compliance opinion date:
  31/03/2023
• Compliance outcome:
  Positive

Decision

P/0036/2021: EMA decision of 27 January 2021 on the acceptance of a modification of an agreed paediatric investigation plan for crizotinib (Xalkori) (EMEA-001493-PIP03-18-M01)

AdoptedReference Number: EMA/34215/2021