EMA/PE/0000235999 - paediatric investigation plan

finerenone

Key facts

• Invented name:
  Kerendia
• Active substance:
  finerenone
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  EMA/PE/0000235999
• PIP number:
  EMA/PE/0000235999
• Pharmaceutical form(s):
  • Film-coated tablet
  • Granules for oral suspension
• Condition(s) / indication(s):
  Treatment of chronic kidney disease
• 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:
  Nej

Decision

EMA/PE/0000235999 :EMA decision of 14 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for finerenone (Kerendia)

Adopted Reference Number: EMADOC-1700519818-2037384