VYXEOS (Jazz Pharmaceuticals ANZ Pty Ltd)
Product name
VYXEOS
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
193 (255 working days)
Active ingredients
daunorubicin hydrochloride, cytarabine
Registration type
New combination
Indication
New combination
VYXEOS (powder for injection) is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AMLMRC).