MHRA-100957-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • deucravacitinib
Invented Name
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
PIP Number MHRA-100957-PIP01-23-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet Age-appropriate oral solid dosage form
Therapeutic area
Conditions / Indications
Conditions / Indications:
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis & juvenile idiopathic arthritis)
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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):DEUCRAVACITINIB.pdf
Published Date 04/03/2026