AZACITIDINE LWS/ AZACITIDINE ANS/ AZACITIDINE SXP (Southern XP IP Pty Ltd)
Product name
AZACITIDINE LWS/ AZACITIDINE ANS/ AZACITIDINE SXP
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
145 (255 working days)
Active ingredients
azacitidine
Registration type
New generic medicine
Indication
AZACITIDINE LWS/ AZACITIDINE ANS/ AZACITIDINE SXP 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 Leukaemia [CMMoL (10-29% marrow blasts without Myeloproliferative Disorder)],
- Acute Myeloid Leukaemia (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.