EMEA-003104-PIP02-22 - paediatric investigation plan

Favezelimab

pembrolizumab

Key facts

• Active substance:
  • Favezelimab
  • pembrolizumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0153/2023
• PIP number:
  EMEA-003104-PIP02-22
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Hodgkin lymphoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Compliance check done:
  No

Decision

P/0153/2023 : EMA decision of 12 May 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for favezelimab/pembrolizumab (EMEA-003104-PIP02-22)

Reference Number: EMA/170247/2023