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ONUREG (Celgene Pty Ltd)
Product name
ONUREG
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
118 (255 working days)
Active ingredients
azacitidine
Registration type
EOI
Indication
ONUREG (film-coated tablet) is now also indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.