EMEA-003149-PIP01-21-M02 - paediatric investigation plan

odronextamab

Key facts

• Active substance:
  odronextamab
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0005/2024
• PIP number:
  EMEA-003149-PIP01-21-M02
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of mature B cell malignancies
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/01/2024
• Compliance check done:
  Nu

Decision

P/0005/2024 : EMA decision of 10 January 2024 on the acceptance of a modification of an agreed paediatric investigation plan for odronextamab (EMEA-003149-PIP01-21-M02)

Adopted Reference Number: EMA/7743/2024