EMEA-003149-PIP01-21 - paediatric investigation plan

Odronextamab

Key facts

• Active Substance:
  Odronextamab
• Therapeutic area:
  Oncology
• Decision number:
  P/0426/2022
• PIP number:
  EMEA-003149-PIP01-21
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of mature B cell malignancies
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Regeneron Ireland DAC

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  28/10/2022

Decision

P/0426/2022: EMA decision of 28 October 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for odronextamab (EMEA-003149-PIP01-21)

AdoptedReference Number: EMA/825329/2022