EMEA-002101-PIP02-18-M01 - paediatric investigation plan

iodine (131-I) murine IgG1 monoclonal antibody against B7-H3 (131I-omburtamab)

Key facts

• Active substance:
  iodine (131-I) murine IgG1 monoclonal antibody against B7-H3 (131I-omburtamab)
• Therapeutic area:
  Oncology
• Decision number:
  P/0322/2020
• PIP number:
  EMEA-002101-PIP02-18-M01
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of neuroblastoma
• Route(s) of administration:
  Intracerebral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/08/2020
• Compliance check done:
  No

Decision

P/0322/2020: EMA decision of 10 August 2020 on the acceptance of a modification of an agreed paediatric investigation plan for iodine (131-I) murine IgG1 monoclonal antibody against B7-H3 (131I-omburtamab) (EMEA-002101-PIP02-18-M01)

Adopted Reference Number: EMA/415352/2020