MHRA-100443-PIP01-22-M05 (update)

Key Facts

Active Substance
Active Substance:
  • BARICITINIB
Invented Name
Olumiant
PIP Number MHRA-100443-PIP01-22-M05 (update)
Pharmaceutical form(s)
  • Oral suspension
  • Film-coated tablet
Therapeutic area
Therapeutic area:
  • Immunology -Rheumatology-Transplantation
Conditions / Indications
Conditions / Indications:
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis and 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
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-100443-PIP01-22-M05 -C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):BARICITINIB.pdf
Published Date 29/08/2025