EMA/PE/0000225245 - paediatric investigation plan

nedosiran

Key facts

• Active substance:
  nedosiran
• Therapeutic area:
  • Congenital, familial and genetic disorders
  • Uro-nephrology
• Decision number:
  EMA/PE/0000225245
• PIP number:
  EMA/PE/0000225245
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of primary hyperoxaluria
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000225245 : EMA decision of 3 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for nedosiran

Adopted Reference Number: EMADOC-1700519818-1810277