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SOVALDI (sofosbuvir) tablets, for oral use
2014-12-20 09:40:41 来源: 作者: 【 】 浏览:546次 评论:0

HIGHLIGHTS OF PRESCRIBING INFORMATIO

These highlights do not include all the information needed to use SOVALDI safely and effectively. See full prescribing information for SOVALDI.

SOVALDI ® (sofosbuvir) tablets, for oral use
Initial U.S. Approval: 2013

RECENT MAJOR CHANGES

Warnings and Precautions (5.1) 11/2014
 

INDICATIONS AND USAGE

SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. (1)

  • SOVALDI efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection. (
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