MHRA-102252-PIP01-25

Key Facts

Active Substance
Active Substance:
  • mavorixafor
Invented Name
  • Xolremdi
  • Xolremdi
PIP Number MHRA-102252-PIP01-25
Pharmaceutical form(s)
  • Capsule, hard
  • Age appropriate solid formulation
  • Age appropriate liquid formulation
Therapeutic area
Therapeutic area:
  • Immunology -Rheumatology-Transplantation
Conditions / Indications
Conditions / Indications:
  • Treatment of WHIM (Warts, Hypogammaglobulinaemia, Infections, and Myelokathexis) syndrome
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • Norgine Pharmaceuticals Limited
  • Country United Kingdom
  • Tel +441895826606
  • Email MedInfo@norgine.com
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
25/08/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-102252-PIP01-25-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):mavorixafor.pdf
Published Date 04/09/2026