MHRA-100635-PIP01-22-M03 (update)

Key Facts

Active Substance
  • CEDAZURIDINE
  • DECITABINE
Invented Name
  • INAQOVI
  • INAQOVI
  • INQOVI
  • INQOVI
  • Inqovi 35/100
PIP Number MHRA-100635-PIP01-22-M03 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral solid dosage form
Therapeutic area
  • Haematology-Hemostaseology
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of acute myeloid leukaemia
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
24/12/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100635-PIP01-22-M03-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):CEDAZURIDINEDECITABINE.pdf
Published Date 15/07/2026