EMEA-001124-PIP01-10-M05 - paediatric investigation plan

Lomitapide

Key facts

• Invented name:
  Lojuxta
• Active Substance:
  Lomitapide
• Therapeutic area:
  Other
• Decision number:
  P/0362/2022
• PIP number:
  EMEA-001124-PIP01-10-M05
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Treatment of (heterozygous or homozygous) familial hypercholesterolaemia
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Amryt Pharmaceuticals DAC

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  19/09/2022

Decision

P/0362/2022 : EMA decision of 19 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for lomitapide (Lojuxta), (EMEA-001124-PIP01-10-M05)

AdoptedReference Number: EMA/697719/2022