AZACITIDINE EUGIA/ AZACITIDINE EPSL/ EUG-AZACITIDINE (Eugia Pharma (Australia) Pty Ltd)
Product name
AZACITIDINE EUGIA/ AZACITIDINE EPSL/ EUG-AZACITIDINE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
150 (175 working days)
Active ingredients
Azacitidine
Registration type
New generic medicine
Indication
AZACITIDINE EPSL 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