EMEA-002298-PIP01-17-M05 - paediatric investigation plan

Evinacumab

Key facts

• Invented name:
  Evkeeza
• Active substance:
  Evinacumab
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0087/2023
• PIP number:
  EMEA-002298-PIP01-17-M05
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of elevated cholesterol
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/03/2023
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-002298-PIP01-17-M05
• Compliance opinion date:
  23/02/2024
• Compliance outcome:
  Positive

Decision

P/0087/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for evinacumab (Evkeeza), (EMEA-002298-PIP01-17-M05)

Reference Number: EMA/37957/2023