EMEA-001984-PIP03-20 - paediatric investigation plan

Sparsentan

Key facts

• Active Substance:
  Sparsentan
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0024/2021
• PIP number:
  EMEA-001984-PIP03-20
• Pharmaceutical form(s):
  • Age-appropriate oral liquid dosage form
  • Tablet
• Condition(s) / indication(s):
  Treatment of primary IgA nephropathy
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  27/01/2021

Decision

P/0024/2021 : EMA decision of 27 January 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for sparsentan (EMEA-001984-PIP03-20)

AdoptedReference Number: EMA/33164/2021