EMEA-003559-PIP01-23 - paediatric investigation plan

baxdrostat

dapagliflozin propanediol monohydrate

Key facts

• Active substance:
  • baxdrostat
  • dapagliflozin propanediol monohydrate
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  P/0146/2024
• PIP number:
  EMEA-003559-PIP01-23
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of chronic kidney disease
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  06/05/2024
• Compliance check done:
  No

Decision

P/0146/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for baxdrostat / dapagliflozin (propanediol monohydrate) (EMEA-003559-PIP01-23)

Adopted Reference Number: EMA/155785/2024