MHRA-100635-PIP02-24

Key Facts

Active Substance
  • CEDAZURIDINE
  • DECITABINE
Invented Name
  • INAQOVI
  • INQOVI
  • INQOVI
  • Inqovi 35/100
PIP Number MHRA-100635-PIP02-24
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 myelodysplastic syndromes, including juvenile myelomonocytic leukaemia
Route(s) of administration
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):CEDAZURIDINEDECITABINE.pdf
Published Date 28/10/2024