MHRA-100605-PIP01-22

Key Facts

Active Substance
Active Substance:
  • sparsentan
Invented Name
Not available at present
PIP Number MHRA-100605-PIP01-22
Pharmaceutical form(s)
  • Tablet
  • Age-appropriate oral liquid dosage form (oral suspension)
Therapeutic area
Therapeutic area:
  • Uro-Nephrology
Conditions / Indications
Conditions / Indications:
  • Treatment of immunoglobulin A nephropathy
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
Yes
Compliance Check Decision Date
Compliance opinion date
24/05/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100605-PIP01-22-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):sparsentan.pdf
Published Date 25/05/2023