| Document Date: 2015-04-22 23:39:46
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Company Eisai Australia Pty Ltd / GE / / Country Australia / / Currency USD / / MedicalCondition ataxia / additional patient developing dizziness / seizure / partial epilepsy / partial-onset seizures / psychiatric disorders / fatigue / intractable partial epilepsy / headache / seizures / epilepsy / dizziness / day seizure / intractable partial epileptic seizures / secondarily generalised seizures / refractory partial seizures / refractory partial-onset seizures / treatment-refractory partial epilepsy / / MedicalTreatment pharmacotherapy / surgery / adjunctive therapy / / MusicGroup Excel / / Person Chung Lacosamide / Source / Ben-Menachem Efficacy / / Position submission Trial ID/First Author / Category/Program GENERAL / Health Minister / General / pharmacist / neurologist / nurse / / Product Perampanel Ex-man/day Lacosamide Dose/day Tablets DPMQ Ex-man Ex-man DPMQ Tablets / /
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5.12 PERAMPANEL, tablets, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg, Fycompa®, Eisai Australia Pty Ltd Purpose of Application The major submission sought an Authority required (STREAMLINED) listing for adjunctive treat