MHRA-100200-PIP01-21-M03 (update)

Key Facts

Active Substance
Active Substance:
  • REGORAFENIB
Invented Name
  • Stivarga
  • Stivarga
PIP Number MHRA-100200-PIP01-21-M03 (update)
Pharmaceutical form(s)
  • Granules
  • Film-coated tablet
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of all conditions contained in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)
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
17/02/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-100200-PIP01-21-M03-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):REGORAFENIB.pdf
Published Date 10/04/2026