Application Nr Approved Date Route Status External Links
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Indications and Purposes

1 Indications And Usage Iclusig (Ponatinib) Is A Kinase Inhibitor Indicated For The: Treatment Of Adult Patients With Chronic Phase, Accelerated Phase, Or Blast Phase Chronic Myeloid Leukemia (Cml) Or Ph+ All For Whom No Other Tyrosine Kinase Inhibitor (Tki) Therapy Is Indicated. Treatment Of Adult Patients With T315i-Positive Cml (Chronic Phase, Accelerated Phase, Or Blast Phase) Or T315i-Positive Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ All). Iclusig Is A Kinase Inhibitor Indicated For The: Treatment Of Adult Patients With Chronic Phase, Accelerated Phase, Or Blast Phase Chronic Myeloid Leukemia (Cml) Or Ph+ All For Whom No Other Tyrosine Kinase Inhibitor (Tki) Therapy Is Indicated. ( 1 ) Treatment Of Adult Patients With T315i-Positive Cml (Chronic Phase, Accelerated Phase, Or Blast Phase) Or T315i-Positive Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ All). ( 1 ) Limitations Of Use : Iclusig Is Not Indicated And Is Not Recommended For The Treatment Of Patients With Newly Diagnosed Chronic Phase Cml. ( 5.7 ) Limitations Of Use : Iclusig Is Not Indicated And Is Not Recommended For The Treatment Of Patients With Newly Diagnosed Chronic Phase Cml [See Warnings And Precautions (5.7) ] .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ponatinib Hydrochloride PONATINIB HYDROCHLORIDE ZINC36701290

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