| Document Date: 2013-09-27 15:15:17
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City Reference / / Company Pruritus Laboratory / Placebo Group / UCB Inc. / / Currency AED / / Event FDA Phase / Product Recall / Product Issues / / Facility Laboratory Findings / / IndustryTerm machinery / mg/mL oral solution / adequate measuring device / infusion solutions / food / calibrated measuring device / administration site / healthcare providers / / MedicalCondition loss of consciousness / asymptomatic first-degree AV block / marked firstdegree AV block / higher AV block / headache / increased seizure / seizures / delayed multiorgan hypersensitivity / symptomatic hepatitis / diabetic neuropathy / nausea / nephritis / endstage renal disease / Tremor / syncope / Fatigue / Injury / lymphadenopathy / disorder / bradycardia / poisoning / Diarrhea / hepatitis / illness / myocarditis / associated tachycardia / Both atrial fibrillation / seizure disorders / atrial flutter / ataxia / partial-onset seizures / General disorders / Brugada Syndrome / Multiorgan hypersensitivity / severe cardiac disease / Carcinogenesis / vertigo / cardiovascular disease / sick sinus syndrome / fever / pain / vomiting / heart failure / structural heart disease / epilepsy / Atrial fibrillation / dizziness / partial-onset epilepsy / rash and elevated liver enzymes / complete AV block / depression / diplopia / rash / Partial-Onset Seizures VIMPAT / myocardial ischemia / ear and labyrinth disorder vertigo / Eosinophilia / untreated illness / open label epilepsy / / MedicalTreatment intravenous infusion / adjunctive therapy / hemodialysis / / Organization VIMPAT administration / DOSAGE AND ADMINISTRATION / FDA / / / Position General / / Product Stability VIMPAT injection / Sodium Chloride / Dextrose / Antiepileptic Drugs / Ideation Antiepileptic / Lactated Ringer's / VIMPAT Tablets / VIMPAT injection / S-014 / S-009 / S-016 / / Technology AV / Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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NDA[removed]S-014 & S-016 NDA[removed]S-008 & S-009 NDA[removed]S-003 & S-005 FDA Final Labeling Text dated[removed]Page 1 HIGHLIGHTS OF PRESCRIBING INFORMATION