MHRA-100628-PIP01-22

Key Facts

Active Substance
Active Substance:
  • Sibeprenlimab
Invented Name
Not yet available
PIP Number MHRA-100628-PIP01-22
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Uro-Nephrology
Conditions / Indications
Conditions / Indications:
  • Treatment of primary immunoglobulin A nephropathy
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
Yes
Compliance Check Decision Date
Compliance opinion date
16/01/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-100628-PIP01-22-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Sibeprenlimab.pdf
Published Date 15/07/2026