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Darunavir / Etravirine / Lopinavir/ritonavir / Ritonavir / Atazanavir / Antiretroviral drug / Lopinavir / Tipranavir / Tibotec / Chemistry / Organic chemistry / Protease inhibitors


Document Date: 2011-10-12 15:20:19

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City

Reference / /

Company

BR / Tibotec Pharmaceuticals Reference ID / Tibotec Pharmaceuticals / /

Event

FDA Phase / /

Facility

Laboratory Abnormalities Observed / Laboratory Abnormalities / /

IndustryTerm

treatment / food / treatment of HIV / /

MedicalCondition

inflammatory response / INTELENCE®-related rash / Pneumocystis jiroveci pneumonia / drug hypersensitivity / HIV / ear and labyrinth disorders / sluggishness Hematologic Disorders / cytolytic hepatitis / NNRTI-related rash / convulsion / vision Gastrointestinal Disorders / hepatitis C / toxic epidermal necrolysis / hepatitis B / hyperhidrosis / Stevens-Johnson syndrome / hypersomnia / syncope / conjunctivitis / prurigo / severe hypersensitivity / StevensJohnson syndrome / fatigue / angina pectoris / gastritis / erythema multiforme / hypoesthesia / Cardiac Disorders / residual opportunistic infections / hematemesis / hypersensitivity / hepatitis Immune System Disorders / hepatitis / organ dysfunction / constipation / gastroesophageal reflux disease / confusional state / skin and subcutaneous tissue disorders / Nutrition Disorders / blisters / Mediastinal Disorders / central obesity / Immune Reconstitution Syndrome Immune reconstitution syndrome / rash / constitutional findings / Urinary Disorders / dyspnea / amnesia / Carcinogenesis / haemorrhagic stroke / NNRTIrelated rash / joint aches / disorientation / tremor Psychiatric Disorders / stomatitis General Disorders / fever / lipodystrophy / angioneurotic edema / myocardial infarction / severe rash / diabetes mellitus / hepatic failure / angioedema / pancreatitis / rash and peripheral neuropathy / dyslipidemia Nervous System Disorders / infection / Immune System Disorders / Connective Tissue Disorders / vertigo Eye Disorders / hemolytic anemia Hepatobiliary Disorders / sleep disorders / rash / Breast Disorders / chronic hepatitis B / eosinophilia / skin and subcutaneous tissue disorders rash / tuberculosis / /

MedicalTreatment

antiretroviral treatment / antiretroviral therapy / /

Organization

administration of INTELENCE / DOSAGE AND ADMINISTRATION / FDA / /

/

Position

General / /

Product

efavirenz / INTELENCE / itraconazole / carbamazepine / clarithromycin / rifampin / fluconazole / phenytoin / azithromycin / digoxin / nevirapine / lidocaine / ketoconazole / TMC125-C206 / C206 / INTELENCE® / TMC125 / /

Technology

Pharmacokinetics / Pharmacodynamics / /

URL

www.fda.gov/medwatch / /

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