EMA/PE/0000261034 - paediatric investigation plan

ponatinib

Key facts

• Invented name:
  Iclusig
• Active substance:
  ponatinib
• Therapeutic area:
  Oncology
• Decision number:
  EMA/PE/0000261034
• PIP number:
  EMA/PE/0000261034
• 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:
  28/04/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000261034 : EMA decision of 28 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for ponatinib (Iclusig)

Adopted Reference Number: EMADOC-1700519818-2082082