EMEA-003157-PIP01-21 - paediatric investigation plan

Fusion protein composed of the first 2 immunoglobulin (Ig)-like domains of the human ROBO2 fused to human IgG1 Fc (PF-06730512)

Key facts

• Active substance:
  Fusion protein composed of the first 2 immunoglobulin (Ig)-like domains of the human ROBO2 fused to human IgG1 Fc (PF-06730512)
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0431/2022
• PIP number:
  EMEA-003157-PIP01-21
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of focal segmental glomerulosclerosis
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  28/10/2023
• Compliance check done:
  No

Decision

P/0431/2022: EMA decision of 28 October 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for fusion protein composed of the first 2 immunoglobulin (Ig)-like...(EMEA-003157-PIP01-21)

Adopted Reference Number: EMA/808629/2022