INQOVI 35/100 (Otsuka Australia Pharmaceutical Pty Ltd)
Product name
INQOVI 35/100
Date registered
Evaluation commenced
Decision date
Approval time
123 working days (255)
Active ingredients
cedazuridine; decitabine
Registration type
NCE/NBE
Indication
INQOVI 35/100 (tablet) is indicated for the treatment of adult patients with myelodysplastic syndromes (MDS) intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups, and patients with chronic myelomonocytic leukaemia (CMML).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.