EMEA-002492-PIP01-18-M02 - paediatric investigation plan

bempegaldesleukin

Key facts

• Active substance:
  bempegaldesleukin
• Therapeutic area:
  Oncology
• Decision number:
  P/0099/2022
• PIP number:
  EMEA-002492-PIP01-18-M02
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoetic, and lymphoid tissue neoplasms)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  18/03/2022
• Compliance check done:
  No

Decision

P/0099/2022 : EMA decision of 18 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for bempegaldesleukin (EMEA-002492-PIP01-18-M02)

Adopted Reference Number: EMA/149056/2022