EMEA-002907-PIP01-20-M02 - paediatric investigation plan

Epcoritamab

Key facts

• Active Substance:
  Epcoritamab
• Therapeutic area:
  Oncology
• Decision number:
  P/0415/2022
• PIP number:
  EMEA-002907-PIP01-20-M02
• Pharmaceutical form(s):
  • Concentrate for solution for injection
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of mature B-cell lymphoma
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  AbbVie Ltd

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/09/2022

Decision

P/0415/2022 : EMA decision of of 29 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for epcoritamab (EMEA- 002907-PIP01-20-M02)

AdoptedReference Number: EMA/777575/2022