MHRA-100635-PIP01-22-M01 (update)

Key Facts

Active Substance
  • CEDAZURIDINE
  • DECITABINE
Invented Name
  • INAQOVI
  • INAQOVI
  • INQOVI
  • INQOVI
  • Inqovi 35/100
PIP Number MHRA-100635-PIP01-22-M01 (update)
Pharmaceutical form(s)
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 GASTRIC 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):CEDAZURIDINEDECITABINE.pdf
Published Date 15/08/2024