EMEA-003507-PIP01-23 - paediatric investigation plan

baxdrostat

Key facts

• Active substance:
  baxdrostat
• Therapeutic area:
  Vascular disorders
• Decision number:
  P/0527/2023
• PIP number:
  EMEA-003507-PIP01-23
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of hypertension
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/12/2023
• Compliance check done:
  Ne

Decision

P/0527/2023 : EMA decision of 29 December 2023 on the granting of a product specific waiver for baxdrostat (EMEA-003507-PIP01-23)

Reference Number: EMA/553372/2023