EMEA-001984-PIP02-20-M01 - paediatric investigation plan

Sparsentan

Key facts

• Active Substance:
  Sparsentan
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0145/2023
• PIP number:
  EMEA-001984-PIP02-20-M01
• Pharmaceutical form(s):
  • Tablet
  • Age appropriate oral liquid dosage formulation
• Condition(s) / indication(s):
  Treatment of focal segmental glomerulosclerosis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/04/2023

Decision

P/0145/2023 : EMA decision of 21 April 2023 on the acceptance of a modification of an agreed paediatric investigation plan for sparsentan, (EMEA- 001984-PIP02-20-M01)

Reference Number: EMA/173847/2023