EMEA-002214-PIP01-17-M02 - paediatric investigation plan

Inclisiran sodium

Key facts

• Invented name:
  Leqvio
• Active substance:
  Inclisiran sodium
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0322/2023
• PIP number:
  EMEA-002214-PIP01-17-M02
• 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:
  11/08/2023
• Compliance check done:
  No

Decision

P/0322/2023 : EMA decision of 11 August 2023 on the acceptance of a modification of an agreed paediatric investigation plan for inclisiran (sodium) (Leqvio), (EMEA-002214-PIP01-17-M02)

Reference Number: EMA/331021/2023