EMA/PE/0000226166 - paediatric investigation plan

sparsentan

Key facts

• Invented name:
  Filspari
• Active substance:
  sparsentan
• Therapeutic area:
  Uro-nephrology
• Decision number:
  EMA/PE/0000226166
• PIP number:
  EMA/PE/0000226166
• Pharmaceutical form(s):
  • Age appropriate oral liquid dosage formulation
  • Film-coated tablet
• 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:
  Nej

Decision

EMA/PE/0000226166 : EMA decision of 16 May 2025 on the acceptance of a modification of an agreed paediatric investigation plan for sparsentan (Filspari)

Adopted Reference Number: EMADOC-1700519818-2113373