EMEA-003300-PIP01-22 - paediatric investigation plan

zigakibart

Key facts

• Active substance:
  zigakibart
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  P/0033/2024
• PIP number:
  EMEA-003300-PIP01-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of primary IgA nephropathy
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  29/01/2024
• Compliance check done:
  No

Decision

P/0033/2024 : EMA decision of 29 January 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for zigakibart (EMEA-003300-PIP01-22)

Adopted Reference Number: EMA/29579/2024