EMA/PE/0000245403 - paediatric investigation plan

vadadustat

Key facts

• Invented name:
  Vafseo
• Active substance:
  vadadustat
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  EMA/PE/0000245403
• PIP number:
  EMA/PE/0000245403
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral formulation
• Condition(s) / indication(s):
  Treatment of anaemia due to chronic disorders
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/07/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000245403: EMA decision of 11 July 2025 on the acceptance of a modification of an agreed paediatric investigation plan for vadadustat (Vafseo)

Adopted Reference Number: EMADOC-1700519818-2235588