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
• Contact for public enquiries:

  Incyte Biosciences Distribution B.V.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/04/2022

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)

AdoptedReference Number: EMA/157567/2022