EMA/PE/0000245173 - paediatric investigation plan

iptacopan

Key facts

• Invented name:
  Fabhalta
• Active substance:
  iptacopan
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  EMA/PE/0000245173
• PIP number:
  EMA/PE/0000245173
• Pharmaceutical form(s):
  • Age appropriate oral solid dosage form
  • Capsule, hard
• Condition(s) / indication(s):
  Treatment of primary IgA nephropathy
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/06/2025
• Compliance check done:
  No

Decision

EMA/PE/0000245173 : EMA decision of 13 June 2025 on the acceptance of a modification of an agreed paediatric investigation plan for iptacopan (Fabhalta)

Adopted Reference Number: EMADOC-1700519818-2197183 Corr