EMA/PE/0000225594 - paediatric investigation plan

imlifidase

Key facts

• Invented name:
  Idefirix
• Active substance:
  imlifidase
• Therapeutic area:
  Surgical and medical procedures
• Decision number:
  EMA/PE/0000225594
• PIP number:
  EMA/PE/0000225594
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Prevention of graft rejection following solid organ transplantation
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/01/2025
• Compliance check done:
  Non

Decision

EMA/PE/0000225594 : EMA decision of 28 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for imlifidase (Idefirix)

Adopted Reference Number: EMADOC-1700519818-1859783