EMEA-002705-PIP01-19-M01 - paediatric investigation plan

Iptacopan

Key facts

• Active Substance:
  Iptacopan
• Therapeutic area:
  Other
• Decision number:
  P/0164/2023
• PIP number:
  EMEA-002705-PIP01-19-M01
• Pharmaceutical form(s):
  • Capsule (hard)
  • Age-appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of C3 glomerulopathy
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Novartis Europharm Limited

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/05/2024

Decision

P/0164/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for iptacopan (EMEA- 002705-PIP01-19-M01)

Reference Number: EMA/160444/2023