EMA/PE/0000184400 - paediatric investigation plan

dapagliflozin

eplerenone

Key facts

• Active substance:
  • dapagliflozin
  • eplerenone
• Therapeutic area:
  Cardiac disorders
• Decision number:
  EMA/PE/0000184400
• PIP number:
  EMA/PE/0000184400
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of heart failure
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  05/12/2024
• Compliance check done:
  No

Decision

EMA/PE/0000184400 : EMA decision of 5 December 2024 on the granting of a product specific waiver for dapagliflozin / eplerenone

Adopted Reference Number: EMADOC-1700519818-1791938