EMEA-002705-PIP03-20-M01 - paediatric investigation plan

iptacopan

Key facts

• Invented name:
  Fabhalta
• Active substance:
  iptacopan
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  P/0322/2024
• PIP number:
  EMEA-002705-PIP03-20-M01
• Pharmaceutical form(s):
  • Age appropriate formulation
  • Capsule, hard
• Condition(s) / indication(s):
  Treatment of paroxysmal nocturnal haemoglobinuria
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0322/2024 : EMA decision of 13 September 2024 on the acceptance of a modification of an agreed paediatric investigation plan for iptacopan (Fabhalta), (EMEA-002705-PIP03-20-M01)

Adopted Reference Number: EMA/411560/2024