MHRA-101304-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • FILGOTINIB MALEATE
Invented Name
  • Jyseleca
  • Jyseleca
  • Jyseleca
  • Jyseleca
  • Jyseleca
PIP Number MHRA-101304-PIP01-23-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet. Age-appropriate oral dosage form.
Therapeutic area
Therapeutic area:
  • Gastroenterology-Hepatology
Conditions / Indications
Conditions / Indications:
  • Treatment of ulcerative colitis
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):FILGOTINIB MALEATE.pdf
Published Date 01/05/2024