EMEA-001623-PIP03-20-M01 - paediatric investigation plan

Finerenone

Key facts

• Active substance:
  Finerenone
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0365/2022
• PIP number:
  EMEA-001623-PIP03-20-M01
• 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:
  09/09/2022
• Compliance check done:
  No

Decision

P/0365/2022: EMA decision of 9 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for finerenone (Kerendia), (EMEA-001623-PIP03-20-M01)

Reference Number: EMA/697757/2022