MHRA-100031-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • PALBOCICLIB
Invented Name
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • blisters in an outer carton/21 and 63 tablets
  • Ibrance
PIP Number MHRA-100031-PIP01-21-M02 (update)
Pharmaceutical form(s)
  • Capsule, hard
  • Film-coated tablet
  • Age-appropriate oral dosage form
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of Ewing sarcoma (EWS)
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
23/10/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-100031-PIP01-21-M02-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):PALBOCICLIB.pdf
Published Date 14/04/2026