EMEA-003642-PIP01-24 - paediatric investigation plan

dexfadrostat phosphate

Key facts

• Active substance:
  dexfadrostat phosphate
• Therapeutic area:
  Endocrine disorders
• Decision number:
  P/0366/2024
• PIP number:
  EMEA-003642-PIP01-24
• Pharmaceutical form(s):
  Capsule, hard
• 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:
  25/10/2024
• Compliance check done:
  No

Decision

P/0366/2024 : EMA decision of 25 October 2024 on the granting of a product specific waiver for dexfadrostat phosphate, (EMEA-003642-PIP01-24)

Adopted Reference Number: EMA/482812/2024