MHRA-102324-PIP01-26-M01 (update)

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • CABOZANTINIB
Invented Name
Cabometyx
PIP Number MHRA-102324-PIP01-26-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Capsule, hard Tablet
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of malignant solid tumours
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 Check Procedure Number
Compliance procedure number
MHRA-102324-PIP01-26-M01-C

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):CABOZANTINIB.pdf
Published Date 16/07/2026