EMEA-000157-PIP01-07-M06 - paediatric investigation plan

belatacept

Key facts

• Invented name:
  Nulojix
• Active substance:
  belatacept
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  P/0351/2024
• PIP number:
  EMEA-000157-PIP01-07-M06
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Prevention of rejection of transplanted kidney
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  27/09/2024
• Compliance check done:
  No

Decision

P/0351/2024 : EMA decision of 27 September 2024 on the acceptance of a modification of an agreed paediatric investigation plan for belatacept (Nulojix), (EMEA-000157-PIP01-07-M06)

Adopted Reference Number: EMA/441696/2024