Note: Ingredients listed on restricted chemical lists
EC/CAS
232-674-9/9004-34-6
Name of the chemical
cellulose
Concentration
17-19%
EC/CAS
236-675-5/13463-67-7
Name of the chemical
Reaction mass of titanium dioxide and silver chloride
Concentration
0.7-0.8%
EC/CAS
209-150-3
Name of the chemical
Aluminium, zinc, magnesium and calcium stearates
Concentration
1-2%
General Information
Revision date
2016-09-19
Product name
Harvoni
Product Synonyms
SOF/LDV FDC tablets
Chemical name
Anti-viral
1.2.1 Relevant identified uses
Bulk formulated pharmaceutical mixture/Formulated pharmaceutical product/ mixture packaged in final form for patient use and uses advised against
Emergency telephone
+1 (800) 424-9300, +1 (703) 527-3887
Icons in SDS
Company Information
company name
Gilead Sciences, Inc
e-mail address of the competent person responsible for the Safety Data Sheet
msdscoordinator@gilead.com
GHS Information
Signal word
None required
Section 2
SECTION 2: Hazards identification
WHMIS 2015 Classification of the substance or mixture Drugs in the finished state and intended for the final user are not subject to labeling in the US, EU or Canada. Please consult the prescribing/packaging information. The classification and labeling listed below is for bulk drug product Globally Harmonized System [GHS] Not classified
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
Sofosbuvir was well tolerated in human clinical trials when administered with other agents, with adverse events including fatigue, irritability, insomnia, decreased hemoglobin and increased blood bilirubin. When administered to healthy subjects, doses of up to 120 mg/twice a day of ledipasvir were generally well tolerated. Adverse effects related to ledipasvir treatment in clinical trials with HCV patients were mild and infrequent, with the most frequent effects being headache, fatigue, nausea, and pruritic rash. Rashes have been observed during post marketing surveillance following therapeutic, oral administration of ledipasvir. Note This mixture does not meet criteria for classification under GHS as implemented
2.1 Classification of the substance or mixture
Drugs in the finished state and intended for the final user are not subject to substance or mixture
