EMA/PE/0000237559 - paediatric investigation plan

azilsartan medoxomil

Key facts

• Invented name:
  Edarbi
• Active substance:
  azilsartan medoxomil
• Therapeutic area:
  Vascular disorders
• Decision number:
  EMA/PE/0000237559
• PIP number:
  EMA/PE/0000237559
• 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:
  14/04/2025
• Compliance check done:
  No

Decision

EMA/PE/0000237559 : EMA decision of 10 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for azilsartan medoxomil (Edarbi)

Adopted Reference Number: EMADOC-1700519818-2035729