| Document Date: 2012-12-19 10:32:14
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City Reference / / Company Vertex Pharmaceuticals Incorporated / / Event Reorganization / Product Issues / FDA Phase / / Facility Laboratory Tests / / IndustryTerm food / intrauterine devices / / MedicalCondition Serious Skin Reactions/Rash / rash progresses / *Rash / HIV / anal pruritus / headache / HBV / myopathy / skin disorders / Stevens Johnson Syndrome / pulmonary arterial hypertension / hemorrhoids / nausea / nephritis / cirrhosis / compensated liver disease / hepatitis C / Toxic Epidermal Necrolysis / syncope / gout / Torsade de Pointes / fatigue / gout/gouty arthritis / estrogen deficiency / bullae / diarrhea / Anemia Anemia / hepatitis / end-stage renal disease / pruritus / liver disease / birth defects / familial Mediterranean fever / progressive severe rash / skin and subcutaneous tissue disorders / hypotension / fetal deaths / sinus tachycardia / dysgeusia / Carcinogenesis / erectile dysfunction / triazolam depression / HCV / fever / Rash events / vomiting / Reactions/Rash / concomitant disease / ANTI GOUT / severe rash / fetal death / respiratory depression / dizziness / rash / progressive rash / Anemia / Chronic Hepatitis C / Eosinophilia / HCV RNA / / MedicalTreatment birth control / blood transfusion / hormone replacement therapy / organ transplants / contraception / hemodialysis / organ transplant / drug therapy / contraceptive methods / / Organization administration of INCIVEK / efavirenz* Concomitant administration / Concomitant administration / REVERSE TRANSCRIPTASE INHIBITORS efavirenz* Concomitant administration / US Federal Reserve / DOSAGE AND ADMINISTRATION / FDA / / Person Stevens Johnson / / / Position General / Major / / Product efavirenz / methylprednisolone / INCIVEK tablets / itraconazole / DOSAGE FORMS AND STRENGTHS Each tablet / dexamethasone / escitalopram / simvastatin / cyclosporine / carbamazepine / triazolam / Each / peginterferon / clarithromycin / erythromycin / repaglinide / nifedipine / Rifampin / Revatio / tenofovir disoproxil fumarate / phenytoin / estradiol / digoxin / ribavirin / lidocaine / ketoconazole / alprazolam / prednisone / felodipine / Lovastatin / zolpidem / CYP3A / ribavirin dose reductions / / Region Mediterranean / / Technology Alpha / ESA / Transplantation / Pharmacokinetics / Pharmacodynamics / genotype / / URL www.fda.gov/medwatch / /
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INCIVEKTM (telaprevir) Film Coated Tablets