EMA/PE/0000232482 - paediatric investigation plan

tegoprubart

Key facts

• Active substance:
  tegoprubart
• Therapeutic area:
  Immune system disorders
• Decision number:
  EMA/PE/0000232482
• PIP number:
  EMA/PE/0000232482
• 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:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/07/2025
• Compliance check done:
  Non

Decision

EMA/PE/0000232482 : EMA decision of 11 July 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tegoprubart

Adopted Reference Number: EMADOC-1700519818-2221995