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Eslicarbazepine acetate (Zebinix) - epilepsy Final Appraisal Recommendation Advice No: 1019 – June 2019 Eslicarbazepine acetate (Zebinix ® ) 200 mg and 800 mg tablets, and 50 mg/ml oral suspension Limited submission by Eisai Ltd Additional note(s): • This advice incorporates and replaces the existing AWMSG recommendation for eslicarbazepine acetate (Zebinix ® ) as an option for restricted use within NHS Wales. Eslicarbazepine acetate should be restricted to treatment of highly refractory (...) Report (ASAR), the Preliminary Appraisal Recommendation (PAR) and the applicant company’s response to the PAR, clinical expert opinion (where available), the views of patients/patient carers (where available) and the lay member perspective. This recommendation has been ratified by Welsh Government and will be considered for review every three years. Recommendation of AWMSG Eslicarbazepine acetate (Zebinix ® ) is recommended as an option for restricted use within NHS Wales. Eslicarbazepine acetate
Eslicarbazepine acetate (Zebinix) - as adjunctive therapy in adolescents and children aged above 6 years with partial-onset seizures Published 11 February 2019 Product Update: eslicarbazepine acetate 200mg and 800mg tablets and oral suspension 50mg/mL (Zebinix ® ) SMC2087 Eisai Ltd 10 August 2018 (Issued 11 January 2019) The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use (...) in NHS Scotland. The advice is summarised as follows: ADVICE: following an abbreviated submission eslicarbazepine acetate (Zebinix ® ) is accepted for restricted use within NHSScotland. Indication under review: as adjunctive therapy in adolescents and children aged above 6 years with partial-onset seizures with or without secondary generalisation. SMC restriction: patients with highly refractory epilepsy who have been heavily pre-treated and remain uncontrolled with existing anti-epileptic drugs. SMC
Eslicarbazepine acetate (Zebinix) - treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy Non Submission eslicarbazepine acetate 200mg and 800mg tablets (Zebinix ® ) SMC2090 Eisai Ltd 4 May 2018 ADVICE: in the absence of a submission from the holder of the marketing authorisation eslicarbazepine acetate (Zebinix ® ) is not recommended for use within NHS Scotland. Indication under review: As monotherapy in the treatment of partial
Aptiom (eslicarbazepine acetate) - As an add-on medication to treat seizures associated with epilepsy Drug Approval Package: Brand Name (Generic Name) NDA # Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Aptiom (Eslicarbazepine Acetate) Tablets Company: Sunovion Inc. Application No.: 022416 Approval Date: 11/08/2013 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. (PDF) (PDF) (PDF) (PDF
Eslicarbazepine acetate (Zebinix®) 800 mg tablets Eslicarbazepine acetate (Zebinix®) 800 mg tablets Eslicarbazepine acetate (Zebinix®) 800 mg tablets All Wales Medicines Strategy Group (AWMSG) Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation All Wales Medicines Strategy Group (AWMSG). Eslicarbazepine acetate (Zebinix®) 800 mg tablets. Penarth: All Wales (...) Therapeutics and Toxicology Centre (AWTTC), secretariat of the All Wales Medicines Strategy Group (AWMSG). AWMSG Secretariat Assessment Report Advice No. 3512. 2012 Authors' conclusions Eslicarbazepine acetate (Zebinix®) is recommended as an option for restricted use within NHS Wales. Eslicarbazepine acetate (Zebinix®) should be restricted to treatment of highly refractory patients who remain uncontrolled with, or are intolerant to, other anti-epileptic medicine combinations, within its licensed indication