EMA/PE/0000227014 - paediatric investigation plan

baxdrostat

Key facts

• Active substance:
  baxdrostat
• Therapeutic area:
  Endocrine disorders
• Decision number:
  EMA/PE/0000227014
• PIP number:
  EMA/PE/0000227014
• Pharmaceutical form(s):
  Coated tablet
• Condition(s) / indication(s):
  Treatment of primary aldosteronism
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/04/2025
• Compliance check done:
  Ei

Decision

EMA/PE/0000227014 : EMA decision of 14 April 2025 on the granting of a product specific waiver for baxdrostat

Adopted Reference Number: EMADOC-1700519818-2035651