MHRA-100635-PIP01-22

Key Facts

Active Substance
  • CEDAZURIDINE
  • DECITABINE
Invented Name
  • INQOVI
  • INQOVI
  • Inqovi 35/100
  • INAQOVI
PIP Number MHRA-100635-PIP01-22
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
  • Oral use
  • Gastric 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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

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