EMEA-001849-PIP02-15-M05 - paediatric investigation plan

avelumab

Key facts

• Invented name:
  Bavencio
• Active substance:
  avelumab
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0312/2024
• PIP number:
  EMEA-001849-PIP02-15-M05
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)
  • Treatment of malignant neoplasms of lymphoid tissue
  • Treatment of malignant neoplasms of the central nervous system
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  22/08/2024
• Compliance check done:
  Nem

Decision

P/0312/2024: EMA decision of 22 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for avelumab (Bavencio), (EMEA-001849-PIP02-15-M05)

Adopted Reference Number: EMA/374089/2024