| Document Date: 2014-07-01 11:11:24
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Company Janssen Products LP / ITT / Note / Alteon Inc. / / Currency pence / / Event FDA Phase / / Facility Laboratory Parameter Abnormality / Laboratory Parameters / Laboratory Abnormalities / / IndustryTerm treatment / treatment of HIV / / MedicalCondition inflammatory response / cholecystitis / Pneumocystis jiroveci pneumonia / Depressive Disorders / HIV / headache / Mycobacterium avium infection / appetite Nervous System Disorders / Gastrointestinal Disorders Abdominal pain Nausea Vomiting General Disorders / somnolence Psychiatric Disorders / adverse reaction depressive disorders / abdominal discomfort Hepatobiliary Disorders / hepatitis C / hepatitis B / Severe depressive disorders / hepatic dysfunction / Torsade de Pointes / glomerulonephritis / residual opportunistic infections / diarrhea / Graves’ disease / liver disease / Gastrointestinal Disorders / nephrolithiasis / hepatic disease / adrenal insufficiency / immune reconstitution syndrome / Nutrition Disorders / Genitourinary Disorders / Autoimmune disorders / insomnia / central obesity / Immune Reconstitution Syndrome Immune reconstitution syndrome / Urinary Disorders / Guillain-Barré syndrome / Carcinogenesis / dysphoria / major depression / pre-existing hepatic disease / nephrotic syndrome / psychiatric disorders / infection / sleep disorders / depression / rash / polymyositis / tuberculosis / / MedicalTreatment antiretroviral treatment / antiretroviral therapy / / Organization FDA / / / Position investigator / Gastrointestinal Disorders Abdominal pain Nausea Vomiting General / / Product efavirenz / dexamethasone / carbamazepine / ACTH / omeprazole / rifampin / pantoprazole / phenytoin / ECHO / nevirapine / lansoprazole / oxcarbazepine / lamivudine / didanosine / rabeprazole / treatment-naïve / EDURANT / CYP3A / TMC278-C204 / 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 EDURANT® safely and effectively. See full prescribing information for EDURANT. EDURANT (rilpivirine) tablets for or