EMEA-002493-PIP01-18-M06 - paediatric investigation plan

nedosiran

Key facts

• Active substance:
  nedosiran
• Therapeutic area:
  • Congenital, familial and genetic disorders
  • Uro-nephrology
• Decision number:
  P/0064/2024
• PIP number:
  EMEA-002493-PIP01-18-M06
• 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:
  08/03/2024
• Compliance check done:
  No

Decision

P/0064/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for nedosiran, (EMEA- 002493-PIP01-18-M06)

Adopted Reference Number: EMA/PDCO/480620/2023