MHRA-100567-PIP01-22-M02 (update)

Key Facts

Active Substance
Active Substance:
  • DINUTUXIMAB BETA
Invented Name
Qarziba
PIP Number MHRA-100567-PIP01-22-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for infusion Concentrate for solution for infusion Powder and solvent for solution for injection Powder for solution for infusion
Therapeutic area
Conditions / Indications
Conditions / Indications:
  • Treatment of neuroblastoma.
Route(s) of administration
Route(s) of administration:
  • Intravenous 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-100567-PIP01-22-M02-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):DINUTUXIMAB BETA.pdf
Published Date 24/10/2025