EMEA-002705-PIP02-19-M01 - paediatric investigation plan

iptacopan

Key facts

• Active substance:
  iptacopan
• Therapeutic area:
  Other
• Decision number:
  P/0443/2023
• PIP number:
  EMEA-002705-PIP02-19-M01
• 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:
  27/10/2023
• Compliance check done:
  No

Decision

P/0443/2023 : EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for iptacopan (EMEA- 002705-PIP02-19-M01)

Adopted Reference Number: EMA/401493/2023