EMEA-001186-PIP01-11-M03 - paediatric investigation plan

ponatinib

Key facts

• Invented name:
  Iclusig
• Active substance:
  ponatinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0122/2022
• PIP number:
  EMEA-001186-PIP01-11-M03
• Pharmaceutical form(s):
  • Film-coated tablet
  • Capsule, hard
  • Age appropriate formulation
• Condition(s) / indication(s):
  • Treatment of chronic myeloid leukaemia
  • Treatment of Philadelphia chromosome positive acute lymphoblastic leukaemia
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/04/2022
• Compliance check done:
  Ne

Decision

P/0122/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ponatinib (Iclusig), (EMEA-001186-PIP01-11-M03)

Adopted Reference Number: EMA/157567/2022