EMEA-001124-PIP01-10-M06 - paediatric investigation plan

Lomitapide

Key facts

• Invented name:
  Lojuxta
• Active substance:
  Lomitapide
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0374/2024
• PIP number:
  EMEA-001124-PIP01-10-M06
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of (heterozygous or homozygous) familial hypercholesterolaemia
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  24/10/2024
• Compliance check done:
  No

Decision

P/0374/2024: EMA decision of 24 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for lomitapide (Lojuxta), (EMEA-001124-PIP01-10-M06)

Adopted Reference Number: EMA/484891/2024