Vosevi

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture

The classification and labeling listed below is for bulk drug product. substance or mixture Globally Harmonized Not classified System [GHS] Supplemental Mixture not yet fully tested.

Supplemental label elements

Mixture not yet fully tested.

Hazard pictograms

None required

Signal word

None required SECTION 2 - HAZARDS IDENTIFICATION …continued

Hazard statements

None required

Precautionary statements

None required

2.3 Other hazards

Mixture not fully tested. Oral coadministration of sofosbuvir and velpatasvir for up to 12 weeks was well tolerated in HCV-infected patients. There was a low rate of treatment discontinuation for adverse events (AEs), and a low incidence of serious, severe or life-threatening AEs, and of laboratory abnormalities. Mild to moderate headache was the most commonly reported effect seen with velpatasvir. Similarly, AEs seen in early clinical trials with voxilaprevir were mild and infrequent (most commonly, headache, nausea, and constipation). No clinically significant AEs have been specifically attributed to sofosbuvir in patients treated with other pharmaceutical mixtures containing sofosbuvir. Note This product does not meet criteria for classification under GHS as implemented