EMEA-001849-PIP02-15-M04 - paediatric investigation plan

avelumab

Key facts

• Invented name:
  • Bavencio
  • Bavencio
• Active Substance:
  avelumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0546/2021
• PIP number:
  EMEA-001849-PIP02-15-M04
• 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
• Contact for public enquiries:

  Merck Healthcare KGaA

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/12/2021

Decision

P/0546/2021: EMA decision of 31 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for avelumab (Bavencio), (EMEA-001849-PIP02-15-M04)

AdoptedReference Number: EMA/709533/2021