Zelboraf

Product manufactured by Genentech, Inc.

Application Nr Approved Date Route Status External Links
NDA202429 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Zelboraf ® Is A Kinase Inhibitor Indicated For The Treatment Of Patients With Unresectable Or Metastatic Melanoma With Braf V600e Mutation As Detected By An Fda-Approved Test. ( 1.1 , 2.1 ) Zelboraf ® Is Indicated For The Treatment Of Patients With Erdheim- Chester Disease With Braf V600 Mutation. ( 1.2 , 2.1 ) Limitation Of Use: Zelboraf Is Not Indicated For Treatment Of Patients With Wild-Type Braf Melanoma ( 2.1 , 5.2 ) 1.1 Unresectable Or Metastatic Melanoma Zelboraf ® Is Indicated For The Treatment Of Patients With Unresectable Or Metastatic Melanoma With Braf V600e Mutation As Detected By An Fda-Approved Test. Limitation Of Use: Zelboraf Is Not Indicated For Treatment Of Patients With Wild-Type Braf Melanoma [See Warnings And Precautions (5.2) ] . 1.2 Erdheim-Chester Disease Zelboraf ® Is Indicated For The Treatment Of Patients With Erdheim-Chester Disease (Ecd) With Braf V600 Mutation.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Vemurafenib VEMURAFENIB ZINC52509366

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