| Document Date: 2014-09-16 17:54:34
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Company Gilead Sciences Inc. / / Event FDA Phase / / Facility Appropriate laboratory / Laboratory Abnormalities / / IndustryTerm hepatitis B therapy / food / treatment of HIV / / MedicalCondition DF / cholecystitis / Fanconi syndrome / Depressive disorders / HIV / cholelithiasis / headache / HBV / hyperpigmentation / liver failure / dysfunction / nausea / peripheral neuritis / rhinitis / hepatitis B / peripheral neuropathy / Arthralgias / Torsade de Pointes / fatigue / injury / Obesity / glomerulonephritis / diarrhea / sinusitis / liver disease / back pain / nephrolithiasis / respiratory tract infection / Immune reconstitution syndrome / abdominal pain / Autoimmune disorders / insomnia / pneumonia / opportunistic infections / disease / arthralgia / nasopharyngitis / hypophosphatemia / Carcinogenesis / fever / vomiting / LACTIC ACIDOSIS / osteomalacia / osteoporosis / infection / dizziness / cough / sleep disorders / depression / rash / chronic hepatitis B / paresthesia / acute renal failure / syndrome / inflammatory / disorders / polymyositis / tuberculosis / / MedicalTreatment antiretroviral treatment / antiretroviral therapy / renal replacement therapy / / Organization Federal Trade Commission / FDA / / / Position Major / / Product Combivir / efavirenz / EMTRIVA / THRIVE / Trizivir / dexamethasone / TRUVADA / carbamazepine / Vitamin D / HEPSERA / Epivir / omeprazole / rifampin / pantoprazole / Epzicom / Epivir-HBV / tenofovir disoproxil fumarate / phenytoin / lansoprazole / oxcarbazepine / lamivudine / VIREAD / ATRIPLA / rabeprazole / HEPSERA® / TMC278-C209 / / Technology Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COMPLERA safely and effectively. See full prescribing information for COMPLERA. •