EMA/PE/0000241538 - paediatric investigation plan

finerenone

Key facts

• Invented name:
  Kerendia
• Active substance:
  finerenone
• Therapeutic area:
  Cardiac disorders
• Decision number:
  EMA/PE/0000241538
• PIP number:
  EMA/PE/0000241538
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate formulation
• Condition(s) / indication(s):
  Treatment of heart failure
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/05/2025
• Compliance check done:
  No

Decision

EMA/PE/0000241538 : EMA decision of 16 May 2025 on the acceptance of a modification of an agreed paediatric investigation plan for finerenone (Kerendia)

Adopted Reference Number: EMADOC-1700519818-2115705