EMEA-000157-PIP01-07-M05 - paediatric investigation plan

belatacept

Key facts

• Invented name:
  Nulojix
• Active Substance:
  belatacept
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0277/2020
• PIP number:
  EMEA-000157-PIP01-07-M05
• 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:
  15/07/2020

Decision

P/0277/2020 : EMA decision of 15 July 2020 on the acceptance of a modification of an agreed paediatric investigation plan for belatacept (Nulojix) (EMEA-000157-PIP01-07-M05)

AdoptedReference Number: EMA/370780/2020