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Medicine / Fixed dose combination / Bristol-Myers Squibb / Organofluorides / Tenofovir / Emtricitabine/tenofovir/efavirenz / Emtricitabine / Antiretroviral drug / Efavirenz / Gilead Sciences / Chemistry / Pharmacology


Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology Pediatric Postmarketing Pharmacovigilance and Dru
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City

Reference / /

Company

Gilead Sciences Inc. / FDAAA Best Pharmaceuticals / Encuity Research LLC. / IMS Health / /

Country

United States / /

Event

FDA Phase / /

Facility

Mail-order/specialty pharmacy / /

IndustryTerm

individual products / combination tenofovir-containing products / non-retail pharmacy settings data / tenofovir-containing product / retail / outpatient retail pharmacies / non-retail settings / food / outpatient retail pharmacy utilization patterns / non-retail channels / treatment of HIV / pediatric age / tenof products / tenofovir-containing products / combination products / /

MedicalCondition

optic atrophy / Fanconi syndrome / HIV / headache / HBV / w/o Coma / acute encephalopathy / nausea / compensated liver disease / hepatitis B / diarrhea / pruritus / liver disease / renal dysfunction / blindness / Immune reconstitution syndrome / abdominal pain / insomnia / disease / vomiting / pain / pancreatitis / osteoporosis / infection / dizziness / depression / Specific Infection / rash / chronic hepatitis B / acute renal failure / /

MedicalTreatment

antiretroviral therapy / Hemodialysis / dialysis / /

OperatingSystem

OSE / /

Organization

office of Surveillance / DOSAGE AND ADMINISTRATION / FDA / /

Person

Gastroenterology Osteopathic / Hina Mehta / Scott Proestel / Judy Staffa / /

/

Position

physician / Kelly Cao / PharmD Division / Director Division of Pharmacovigilance / contractor / Director Division of Epidemiology / Evaluator / EXECUTIVE / Nurse / Office-Based Physician / Analyst / Internal Medicine Nurse Practitioner Family Practice Physician Assistant / CONTENTS Executive / /

Product

efavirenz / TRUVADA / HEPSERA / tenofovir disoproxil fumarate / National / Viread / Didanosine / ATRIPLA / Appendix A. Drug / HIV-1 / VIREAD oral / Viread® / /

Technology

dialysis / /

URL

www.fda.gov/medwatch / /

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