MHRA-100496-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • RUXOLITINIB PHOSPHATE
Invented Name
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
PIP Number MHRA-100496-PIP01-22-M01 (update)
Pharmaceutical form(s)
  • Tablet
  • Age-appropriate oral dosage form
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of acute Graft versus Host Disease (aGvHD)
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 opinion date
19/01/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100496-PIP01-22-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):RUXOLITINIB PHOSPHATE.pdf
Published Date 25/05/2023