MHRA-101112-PIP01-23-M02 (update)

Key Facts

Active Substance
Active Substance:
  • Icotrokinra
Invented Name
Not yet available
PIP Number MHRA-101112-PIP01-23-M02 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate formulation
Therapeutic area
Therapeutic area:
  • Dermatology
Conditions / Indications
Conditions / Indications:
  • Treatment of psoriasis.
Route(s) of administration
Route(s) of administration:
  • Oral 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
16/09/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-101112-PIP01-23-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Icotrokinra.pdf
Published Date 24/10/2025