EMEA-002028-PIP01-16-M04 - paediatric investigation plan

durvalumab

Key facts

• Invented name:
  Imfinzi
• Active substance:
  durvalumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0301/2023
• PIP number:
  EMEA-002028-PIP01-16-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, haematopoietic and lymphoid tissue)
  • Treatment of malignant neoplasms of lymphoid tissue
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/08/2023
• Compliance check done:
  Ei

Decision

P/0301/2023 : EMA decision of 11 August 2023 on the acceptance of a modification of an agreed paediatric investigation plan for durvalumab (Imfinz), (EMEA-002028-PIP01-16-M04)

Reference Number: EMA/336529/2023