EMEA-002183-PIP03-23 - paediatric investigation plan

imlifidase

Key facts

• Invented name:
  Idefirix
• Active substance:
  imlifidase
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  EMEA-002183-PIP03-23
• PIP number:
  EMEA-002183-PIP03-23
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of glomerulonephritis and nephrotic syndrome
• 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:
  14/04/2025
• Compliance check done:
  No

Decision

EMEA-002183-PIP03-23 : EMA decision of 14 April 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for imlifidase

Adopted Reference Number: EMADOC-1700519818-2035629