MHRA-102497-PIP01-26

Key Facts

Active Substance
  • PONATINIB
  • PONATINIB HYDROCHLORIDE
Invented Name
  • Ponatinib Incyte
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
PIP Number MHRA-102497-PIP01-26
Pharmaceutical form(s)
  • Capsule, hard
  • Film-coated tablet
  • Age-appropriate formulation
Therapeutic area
  • Haematology-Hemostaseology
  • Oncology
Conditions / Indications
  • Treatment of chronic myeloid leukaemia (CML)
  • Treatment of acute lymphoblastic leukaemia
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
13/07/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-102497-PIP01-26-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):PONATINIBPONATINIB HYDROCHLORIDE.pdf
Published Date 23/07/2026