EMEA-001623-PIP01-14-M06 - paediatric investigation plan

finerenone

Key facts

• Invented name:
  Kerendia
• Active substance:
  finerenone
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0179/2023
• PIP number:
  EMEA-001623-PIP01-14-M06
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral dosage formulation
• 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:
  17/05/2023
• Compliance check done:
  Nu

Decision

P/0179/2023: EMA decision of 17 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for finerenone (Kerendia), (EMEA-001623-PIP01-14-M06)

Reference Number: EMA/175863/2023