| Document Date: 2013-10-18 05:00:48
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City Philadelphia / / Company NVR / / Facility For laboratory / / IndustryTerm anti-arrhythmic medicinal products / concomitant medicinal products / medicinal products / food / study medicinal product / Food effect / medicinal product / / MedicalCondition rare hereditary problems / Neoplasms / appetite disorder / headache / tinea pedis / arteriosclerosis / cardiac failure / cysts / hyperparathyroidism / xerophthalmia / dysfunction / ventricular extrasystoles / muscle spasms / nausea / pericardial effusion / stomatitis / thrombocytopenia / pleurisy / herpes / rhinitis / alopecia / peripheral neuropathy / tremor / tumour lysis syndrome / Lapp lactase deficiency / syncope / relevant cardiac disorders / leukaemia / conjunctivitis / gout / torsade de pointes / unstable angina / fatigue / angina pectoris / atrioventricular block / gastritis / chronic phase / bradycardia / lymphopenia / tachycardia / hypersensitivity / constipation / papilloma / pruritus / Infections / respiratory tract infection / pericarditis / nutrition disorders / arrhythmia / abdominal pain / insomnia / epistaxis / congestive heart failure / hypertension / gingivitis / gastric ulcer / Nervous system disorders / disease / flushing / arthralgia / restless legs syndrome / nasopharyngitis / neutropenia and thrombocytopenia Newly / amnesia / dysgeusia / folliculitis / neutropenia / vertigo / Tumour / migraine / arterial occlusive disease / Upper abdominal pain / hernia / lethargy / oral candidiasis / left bundle branch block / vomiting / Contraindications Hypersensitivity / myocardial infarction / enterocolitis / diabetes mellitus / pleural effusion / pancreatitis / clinically significant dehydration / significant cardiac disease / cardiac disease / chronic phase CML / atrial fibrillation / infection / dizziness / cough / clinically significant bradycardia / depression / pericardial effusions / rash / pharyngitis / abscess / eosinophilia / disorders / pancytopenia / blepharitis / / MedicalTreatment contraception / / Organization Tasigna administration / Concomitant administration / / Position physician / General / / Product hydroxyurea / itraconazole / haloperidol / carbamazepine / PHARMACEUTICAL FORM Hard capsule / clarithromycin / phenytoin / famotidine / Tasigna / ketoconazole / / Technology pharmacokinetics / pharmacodynamics / /
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS