EMEA-002493-PIP01-18-M05 - paediatric investigation plan

Nedosiran

Key facts

• Active Substance:
  Nedosiran
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0007/2023
• PIP number:
  EMEA-002493-PIP01-18-M05
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of primary hyperoxaluria
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Novo Nordisk A/S

  E-mail: [e-mail] ; Tel.: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/02/2023

Decision

P/0007/2023 : EMA decision of 10 February 2023 on the acceptance of a modification of an agreed paediatric investigation plan for nedosiran (EMEA- 002493-PIP01-18-M05)

Reference Number: EMA/640003/2008