MHRA-101307-PIP01-23

Key Facts

Active Substance
Active Substance:
  • inaxaplin
Invented Name
Not yet available
PIP Number MHRA-101307-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film coated tablet
Therapeutic area
Therapeutic area:
  • Uro-Nephrology
Conditions / Indications
Conditions / Indications:
  • Treatment of apolipoprotein L1 (APOL1) -mediated kidney disease
Route(s) of administration
Route(s) of administration:
  • Oral 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):inaxaplin.pdf
Published Date 28/10/2024