MHRA-101671-PIP01-24

Key Facts

Active Substance
Active Substance:
  • PEGCETACOPLAN
Invented Name
  • ASPAVELI
  • ASPAVELI
PIP Number MHRA-101671-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for infusion
Therapeutic area
Therapeutic area:
  • Uro-Nephrology
Conditions / Indications
Conditions / Indications:
  • Treatment of glomerulonephritis and nephrotic syndrome
Route(s) of administration
Route(s) of administration:
  • Subcutaneous 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):PEGCETACOPLAN.pdf
Published Date 02/05/2025