EMEA-001169-PIP01-11-M05 - paediatric investigation plan

alirocumab

Key facts

• Invented name:
  • Praluent
  • Praluent
• Active substance:
  alirocumab
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0550/2021
• PIP number:
  EMEA-001169-PIP01-11-M05
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of elevated cholesterol
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/12/2021
• Compliance check done:
  Ano
• Compliance procedure number:
  EMEA-C-001169-PIP01-11-M05
• Compliance opinion date:
  24/02/2023
• Compliance outcome:
  Positive

Decision

P/0550/2021 : EMA decision of 31 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for alirocumab (Praluent), (EMEA-001169-PIP01-11-M05)

Adopted Reference Number: EMA/706959/2021