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European Economic Area (EEA) Tecfidera™ Marketing authorisation procedure Centralised Brief description of the product Chemical class: Fumarate ester drug product containing the active ingredient DMF Mode of action: The nonclinical pharmacology studies conducted suggest that BG00012 elicits both direct neuroprotective and anti-inflammatoryBiogen has secured a new patent in Europe covering the use of its oral therapy Tecfidera (dimethyl fumarate) for multiple sclerosis (MS) through 2028, the company announced Granted by the multiplesclerosisnewstoday com biogen-granted-european-patent-ms-medicati --- ema europa eu en documents tecfidera-epar-risk-management-plan_en pdfTecfidera is a medicine used to treat multiple sclerosis (MS), a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves It is used in adults and children from 13 years of age with a type of MS known as relapsing-remitting MS, where the patient has flare-ups of symptoms The European Medicines Agency (EMA) has issued new advice for doctors and patients in order to minimise the risk of progressive multifocal leukoencephalopathy (PML) in patients treated with the multiple sclerosis medicine Tecfidera (dimethyl fumarate) PML is a rare brain infection caused by John Cunningham (JC) virus - Biogen Idec to Begin Launching TECFIDERA in Initial EU Countries in the Coming Weeks - CAMBRIDGE, Mass --(BUSINESS WIRE)--TECFIDERA ® (dimethyl fumarate) has been approved by the European Commission (EC) as a first-line oral treatment for people with relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS) pro medicin dk Medicin Praeparater 7399--- ema europa eu tecfidera-h-c-2601-ii-0059-assessment-report-variation_ --- ema europa eu en medicines human EPAR tecfiderareceived Tecfidera 240 mg twice daily (2 capsules of 120 mg) orally for 96 weeks, the same dosing regimen as the approved Tecfidera dosin g regimen in adults with RRMS The clinical study report for Study 109MS202 has previously been submitted to the European Medicines Agency (EMEA H C 002601 II 0042, approved November 2017) TECFIDERA® (dimethyl fumarate) has been approved by the European Commission (EC) as a first-line oral treatment for people with relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS) Biogen Idec (NASDAQ: BIIB) will begin to introduce TECFIDERA in initial European Union (EU) countries in the coming weeks Såfremt en patient udvikler en alvorlig infektion, skal det overvejes at seponere behandlingen, og fordele og risici skal revurderes, før behandlingen genoptages Patienter skal informeres om at rapportere symptomer på infektion til en læge Lægemiddelinduceret leverskade, herunder forhøjede leverenzymer (≥ 3 øvre normalgrænse og investors biogen com tecfiderar-dimethyl-fumarate-approved-european-union --- europeanpharmaceuticalreview com tecfidera-dimethyl-fumarate-approved In the Tecfidera pregnancy registry, 289 prospectively collected pregnancy outcomes were documented in patients with MS who were exposed to dimethyl fumarate The median duration of exposure to dimethyl fumarate was 4 6 gestational weeks with limited exposure after the sixth gestational week (44 pregnancy outcomes) --- ema europa eu updated-recommendations-minimise-risk-rare-brain-infect Tecfidera is a medicine used to treat multiple sclerosis (MS), a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves It is used in adults and children from 13 years of age with a type of MS known as relapsing-remitting MS, where the patient has flare-ups of symptoms --- ema europa eu en documents tecfidera-epar-medicine-overview_en pdf--- ema europa eu en documents tecfidera-epar-product-information_en pdf
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