MHRA-100448-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • RUXOLITINIB PHOSPHATE
Invented Name
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • OPZELURA
PIP Number MHRA-100448-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Cream
Therapeutic area
Therapeutic area:
  • Dermatology
Conditions / Indications
Conditions / Indications:
  • Vitiligo
Route(s) of administration
Route(s) of administration:
  • Topical 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):RUXOLITINIB PHOSPHATE.pdf
Published Date 29/10/2024