EMEA-003218-PIP01-22 - paediatric investigation plan

zilebesiran (sodium)

Key facts

• Active substance:
  zilebesiran (sodium)
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0092/2023
• PIP number:
  EMEA-003218-PIP01-22
• Pharmaceutical form(s):
  Concentrate for solution for injection
• Condition(s) / indication(s):
  Treatment of hypertension
• Route(s) of administration:
  Subcutaneous use
• Decision date:
  10/03/2023
• Compliance check done:
  Nee

Decision

P/0092/2023 : EMA decision of 10 March 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for zilebesiran (sodium) (EMEA-003218-PIP01-22)

Adopted Reference Number: EMA/74715/2023