AZACITIDINE MSN; AZACITIDINE SANDOZ (Accelagen Pty Ltd)
Product name
AZACITIDINE MSN; AZACITIDINE SANDOZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
149 (255 working days)
Active ingredients
azacitidine
Registration type
New generic medicine
Indication
AZACITIDINE MSN; AZACITIDINE SANDOZ (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.