EMEA-001314-PIP01-12-M02 - paediatric investigation plan

Dinutuximab beta
PIPHuman

Key facts

Invented name
Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
Active Substance
Dinutuximab beta
Therapeutic area
Oncology
Decision number
P/0076/2024
PIP number
EMEA-001314-PIP01-12-M02
Pharmaceutical form(s)
  • Solution for infusion
  • Concentrate for solution for infusion
  • Powder and solvent for solution for injection
  • Powder for solution for infusion
Condition(s) / indication(s)
Treatment of neuroblastoma
Route(s) of administration
Intravenous use
Contact for public enquiries
Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

Decision

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