MHRA-100567-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • Dinutuximab beta
Invented Name
  • Qarziba
  • Qarziba
PIP Number MHRA-100567-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for infusion for intravenous use Concentrate for solution for infusion Powder and solvent for solution for injection for intravenous use Powder for solution for infusion for intravenous use
Therapeutic area
Therapeutic area:
  • Oncology
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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Dinutuximab beta.pdf
Published Date 25/05/2023