MHRA-100635-PIP02-24

Key Facts

PIPS 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

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):CEDAZURIDINEDECITABINE.pdf
Published Date 28/10/2024