MHRA-100403-PIP01-21

Key Facts

Active Substance
Active Substance:
  • Fusion protein composed of the first 2 immunoglobulin (Ig)-like domains of the human ROBO2 fused to human IgG1 Fc (PF-06730512)
Invented Name
Not available at present
PIP Number MHRA-100403-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for solution for injection
Therapeutic area
Therapeutic area:
  • Uro-Nephrology
Conditions / Indications
Conditions / Indications:
  • Treatment of focal segmental glomerulosclerosis
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Fusion protein composed of the first 2 immunoglobulin (Ig)-like domains of the human ROBO2 fused to human IgG1 Fc (PF-06730512).pdf
Published Date 07/12/2022