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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):PALBOCICLIB.pdf
Published Date 02/02/2023