EMEA-001944-PIP01-16-M05 - paediatric investigation plan

vadadustat

Key facts

• Invented name:
  Vafseo
• Active substance:
  vadadustat
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  P/0290/2024
• PIP number:
  EMEA-001944-PIP01-16-M05
• Pharmaceutical form(s):
  • 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:
  16/08/2024
• Compliance check done:
  Nee

Decision

P/0290/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for vadadustat (Vafseo), (EMEA-001944-PIP01-16-M05)

Adopted Reference Number: EMA/343517/2024