EMEA-002705-PIP06-23 - paediatric investigation plan

iptacopan

Key facts

• Invented name:
  Fabhalta
• Active substance:
  iptacopan
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0324/2024
• PIP number:
  EMEA-002705-PIP06-23
• Pharmaceutical form(s):
  • Capsule, hard
  • Age-appropriate oral dosage form
• Condition(s) / indication(s):
  Treatment of myasthenia gravis
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0324/2024 : EMA decision of 13 September 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for Iptacopan (Fabhalta), (EMEA-002705-PIP06-23)

Adopted Reference Number: EMA/412202/2024