MHRA-100522-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • CABOZANTINIB
Invented Name
  • Cometriq
  • Cabometyx
  • Cabometyx
  • Cometriq
PIP Number MHRA-100522-PIP01-22-M01 (update)
Pharmaceutical form(s)
  • Capsule, hard
  • Tablet
  • Age-appropriate formulation
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 opinion date
13/10/2022
Compliance Check Procedure Number
Compliance procedure number
MHRA-100522-PIP01-22-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):CABOZANTINIB.pdf
Published Date 07/12/2022