MHRA-101758-PIP01-24

Key Facts

Active Substance
Active Substance:
  • deuruxolitinib
Invented Name
  • LEQSELVI
  • LEQSELVI
PIP Number MHRA-101758-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Tablet, Age appropriate oral formulation.
Therapeutic area
Therapeutic area:
  • Other: immunosuppressant
Conditions / Indications
Conditions / Indications:
  • Treatment of alopecia areata
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 Check Procedure Number
Compliance procedure number
MHRA-101758-PIP01-24-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):deuruxolitinib.pdf
Published Date 28/07/2025