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

Dinutuximab beta

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
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/03/2024
• Compliance check done:
  No

Decision

P/0076/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for dinutuximab beta (Qarziba), (EMEA-001314-PIP01-12-M02)

Adopted Reference Number: EMA/89774/2024