EMEA-000237-PIP01-08-M12 - paediatric investigation plan

azilsartan medoxomil

Key facts

• Invented name:
  Edarbi
• Active substance:
  azilsartan medoxomil
• Therapeutic area:
  Vascular disorders
• Decision number:
  P/0053/2024
• PIP number:
  EMEA-000237-PIP01-08-M12
• Pharmaceutical form(s):
  • Tablet
  • Granules for oral suspension
• Condition(s) / indication(s):
  Treatment of hypertension
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/03/2024
• Compliance check done:
  Nie

Decision

P/0053/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for azilsartan medoxomil (Edarbi), (EMEA-000237-PIP01-08-M12)

Adopted Reference Number: EMA/62603/2024