EMA/PE/0000231576 - paediatric investigation plan

atrasentan

Key facts

• Active substance:
  atrasentan
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  EMA/PE/0000231576
• PIP number:
  EMA/PE/0000231576
• Pharmaceutical form(s):
  • Tablet
  • Age appropriate formulation
• Condition(s) / indication(s):
  Treatment of primary IgA nephropathy
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/05/2025
• Compliance check done:
  Nei

Decision

EMA/PE/0000231576 : EMA decision of 16 May 2025 on the acceptance of a modification of an agreed paediatric investigation plan for atrasentan

Adopted Reference Number: EMADOC-1700519818-2113637