AZACITIDINE-TEVA (Teva Pharma Australia Pty Ltd)
Product name
AZACITIDINE-TEVA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
252 working days (255)
Active ingredients
azacitidine
Registration type
New generic medicine
Indication
AZACITIDINE-TEVA (powder for injection) is indicated for the treatment of patients with:
- Intermediate-2 and high-risk Myelodysplastic Syndromes (MDS) according to the International Prognostic Scoring System (IPSS),
- Chronic Myelomonocytic Leukemia [CMMoL (10%-29% marrow blasts without Myeloproliferative Disorder)],
- Acute Myeloid Leukemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to World Health Organisation Classification (WHO),
in whom allogenic stem cell transplantation is not indicated.