| Document Date: 2015-03-25 07:16:47
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Company Alteon Inc. / / Currency pence / / Event Product Recall / FDA Phase / Product Issues / / IndustryTerm HIV therapy / antiretroviral medicinal products / medicinal products / food / ongoing digital ulcer disease Treatment / hypertension Treatment / / MedicalCondition severe chronic heart failure / severe liver dysfunction / HIV / headache / liver dysfunction / arterial hypertension / pulmonary arterial hypertension / dermatitis / nausea / pulmonary oedema / syncope / severe COPD / fatigue / Pulmonary / pulmonary veno-occlusive disease / Hypersensitivity / pruritus / persistent pulmonary hypertension / flu-like syndrome / severe systolic dysfunction / hypotension / systemic sclerosis / HIV infection / pulmonary hypertension secondary / abdominal pain / red blood cell transfusion1 Uncommon Thrombocytopenia1 Uncommon Neutropenia / disease / arthralgia / scleroderma / significant interstitial pulmonary disease / severe pulmonary arterial hypertension / Common Hypersensitivity / chronic obstructive pulmonary disease / pulmonary hypertension / fever / associated veno-occlusive disease / vomiting / Rare Anaphylaxis / unusual lethargy / heart failure / concomitant left ventricular dysfunction / dizziness / liver injury / rash / / MedicalTreatment antiretroviral therapy / alternative therapy / concomitant therapy / contraception / red blood cell transfusion / alternative therapies / dialysis / / Organization Tracleer administration / World Health Organization / Concomitant administration / / Position gynaecologist / physician / / Product itraconazole / Simvastatin / cyclosporine / carbamazepine / Tracleer / fluconazole / phenytoin / estradiol / Digoxin / nevirapine / PHARMACEUTICAL FORM Film-coated tablet / ketoconazole / CYP3A4 / / PublishedMedium Baseline / / Technology dialysis / /
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1.