EMA/PE/0000231113 - paediatric investigation plan

nemvaleukin alfa

Key facts

• Active substance:
  nemvaleukin alfa
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000231113
• PIP number:
  EMA/PE/0000231113
• Pharmaceutical form(s):
  Powder for solution for injection
• 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 the lymphoid tissue
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/03/2025
• Compliance check done:
  No

Decision

EMA/PE/0000231113 : EMA decision of 21 March 2025 on the acceptance of a modification of an agreed paediatric investigation plan for nemvaleukin alfa

Adopted Reference Number: EMADOC-1700519818-1976293