COMUNICADO: European Commission Grants Marketing Authorisation for Zebinix® (eslicarbazepine acetate) for the Treatment of Partial-O

Actualizado 19/12/2016 1:02:11 CET

1.  European Commission: Community register of medicinal products for human use. Product Information - Zebinix. Available at: http://ec.europa.eu/health/documents/community-register/html/h514.htm Last updated December 2016 2.  Zebinix SMPC, Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000988/WC500047225.pdf   Last updated: May 2016 3.  Moreira J, et al. J Neurol Sci 2015;357:e432-456 (abstract 1513; WFN15-1735; e439) 4.  Hebeisen S, et al. Eslicarbazepine and the enhancement of slow inactivation of voltage-gated sodium channels: a comparison with carbamazepine, oxcarbazepine and lacosamide. Neuropharmacology 2015; 89:122-35 5.  Soares-da-Silva P, et al. Eslicarbazepine acetate for the treatment of focal epilepsy: an update on its proposed mechanisms of action. Pharmacol Res Perspect. 2015; 3:e00124 6.  Elger C, et al. Eslicarbazepine acetate: A double-blind, add-on, placebo-controlled exploratory trial in adult patients with partial-onset seizures. Epilepsia 2007; 48:497-504 7.  Elger C, et al. Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures: A randomised, double-blind, placebo-controlled, parallel-group phase III study. Epilepsia. 2009;50:454-63 8.  Ben-Menachem E, et al. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy. Epilepsy Res. 2010;89(2-3):278-85 9.  Gil-Nagel A, et al. Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in  adults with refractory partial-onset seizures. Acta Neurol Scand. 2009; 120:281-87 10. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. Available at: http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf  Accessed November 2016 11. Pugliatti M, et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007:48(12):2224-33 12. Forsgren L, et al. The epidemiology of epilepsy in Europe - a systematic review. Eur J Neurol. 2005; 12(4):245-53

December 2016

Zebinix-EU0112

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