MHRA-100463-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • spesolimab
Invented Name
Not yet available
PIP Number MHRA-100463-PIP01-22-M01 (update)
Pharmaceutical form(s)
  • Solution for infusion
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Dermatology
Conditions / Indications
  • Treatment of Generalised Pustular Psoriasis
  • Prevention of Generalised Pustular Psoriasis
Route(s) of administration
Route(s) of administration:
  • INTRAVENOUS USE. SUBCUTANEOUS USE
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
19/01/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-100463-PIP01-22-M01 -C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):spesolimab.pdf
Published Date 01/05/2026