MHRA-101661-PIP01-24

Key Facts

Active Substance
Active Substance:
  • RUXOLITINIB PHOSPHATE
Invented Name
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • OPZELURA
PIP Number MHRA-101661-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Cream
Therapeutic area
Therapeutic area:
  • Dermatology
Conditions / Indications
Conditions / Indications:
  • Treatment of atopic dermatitis
Route(s) of administration
Route(s) of administration:
  • Topical use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
01/06/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-101661-PIP01-24-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):RUXOLITINIB PHOSPHATE.pdf
Published Date 23/07/2026