EMA/PE/0000241527 - paediatric investigation plan

baxdrostat

dapagliflozin propanediol

Key facts

• Active substance:
  • baxdrostat
  • dapagliflozin propanediol
• Therapeutic area:
  Cardiac disorders
• Decision number:
  EMA/PE/0000241527
• PIP number:
  EMA/PE/0000241527
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Prevention of heart failure
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  16/05/2025
• Compliance check done:
  No

Decision

EMA/PE/0000241527 : EMA decision of 16 May 2025 on the granting of a product specific waiver for baxdrostat / dapagliflozin propanediol

Adopted Reference Number: EMADOC-1700519818-2107645