{"id":2537,"date":"2018-03-05T12:51:28","date_gmt":"2018-03-05T11:51:28","guid":{"rendered":"https:\/\/prueba.esclerosismultiplegalicia.org\/?p=2537"},"modified":"2025-09-10T11:48:03","modified_gmt":"2025-09-10T09:48:03","slug":"a-ue-revisa-zinbryta-para-a-esclerose-multiple-por-varios-casos-de-trastornos-cerebrais-inflamatorios","status":"publish","type":"post","link":"http:\/\/esclerosismultiplegalicia.org\/index.php\/2018\/03\/05\/a-ue-revisa-zinbryta-para-a-esclerose-multiple-por-varios-casos-de-trastornos-cerebrais-inflamatorios\/","title":{"rendered":"A UE revisa Zinbryta para a Esclerose M\u00faltiple por varios casos de trastornos cerebrais inflamatorios"},"content":{"rendered":"\n<h3 class=\"wp-block-heading has-theme-palette-2-color has-text-color has-link-color wp-elements-aa7cd9602eecdce11f20b0e15c483ad0\"><em>O f\u00e1rmaco foi retirado do mercado europeo de forma voluntaria por Biogen, farmac\u00e9utica encargada da s\u00faa comercializaci\u00f3n<\/em>.<\/h3>\n\n\n\n<h3 class=\"wp-block-heading has-theme-palette-2-color has-text-color has-link-color wp-elements-037b6bc4960ceec46aadf66b5e4fbc08\"><em>A Axencia Europea de Medicamentos recomenda non deixar o tratamento ata consultalo co persoal sanitario<\/em>.<\/h3>\n\n\n\n<p>O Comit\u00e9 de Avaliaci\u00f3n de Riscos de Farmacovigilancia (PRAC) da Axencia Europea de Medicamentos (EMA) comezou unha revisi\u00f3n urxente do medicamento para a Esclerose M\u00faltiple\u00a0Zinbryta (daclizumab) despois de rexistrarse sete casos de trastornos cerebrais\u00a0 inflamatorios graves en Alema\u00f1a, inclu\u00edndo\u00a0encefalitis e\u00a0 meningoencefalitis, e un caso en Espa\u00f1a. Esta comprobaci\u00f3n xorde por mor dunha solicitude da Comisi\u00f3n Europea (CE) do 26 de febreiro de 2018, de conformidade co disposto no artigo 20 do Regulamento n\u00famero 726\/2004.<\/p>\n\n\n\n<p>De forma paralela ao comezo desta revisi\u00f3n, a compa\u00f1\u00eda biotecnol\u00f3xica\u00a0Biogen\u00a0Idec, que \u00e9 a encargada da comercializaci\u00f3n deste f\u00e1rmaco, informou a dita Axencia da s\u00faa intenci\u00f3n de retirar de forma voluntaria as autorizaci\u00f3ns concedidas para a venda do mesmo. As\u00ed mesmo, esta entidade farmac\u00e9utica trasladou \u00e1 EMA a s\u00faa decisi\u00f3n de suspender os estudos cl\u00ednicos en curso con Zinbryta na UE.<\/p>\n\n\n\n<p>Ante esta situaci\u00f3n, dita Axencia aconsella que os pacientes que participan en estudos cl\u00ednicos e te\u00f1an algunha pregunta respecto diso contacten co m\u00e9dico que os trata na devandita investigaci\u00f3n.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Recomendaci\u00f3ns da EMA<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Os m\u00e9dicos non deben comezar o tratamento con Zinbryta en novos pacientes.<\/li>\n\n\n\n<li>Os m\u00e9dicos deben revisar aos pacientes actualmente tratados con Zinbryta e iniciar unha terapia alternativa, tan pronto como sexa posible.<\/li>\n\n\n\n<li>Os pacientes non deben suspender a s\u00faa medicaci\u00f3n sen consultar antes co seu m\u00e9dico.<\/li>\n\n\n\n<li>Os pacientes que te\u00f1an algunha pregunta deben falar directamente co seu m\u00e9dico.<\/li>\n<\/ul>\n\n\n\n<p>Segundo os datos rexistrados pola EMA, ata a data, m\u00e1is de 8.000 pacientes foron tratados con Zinbryta en todo o mundo. A maior\u00eda deles son da Uni\u00f3n Europea (UE), en concreto procedentes de Alema\u00f1a.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>O f\u00e1rmaco foi retirado do mercado europeo de forma voluntaria&hellip; <a class=\"continue\" href=\"http:\/\/esclerosismultiplegalicia.org\/index.php\/2018\/03\/05\/a-ue-revisa-zinbryta-para-a-esclerose-multiple-por-varios-casos-de-trastornos-cerebrais-inflamatorios\/\">Ler m\u00e1is sobre<span> A UE revisa Zinbryta para a Esclerose M\u00faltiple por varios casos de trastornos cerebrais inflamatorios<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":2942,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_kad_post_transparent":"","_kad_post_title":"","_kad_post_layout":"","_kad_post_sidebar_id":"","_kad_post_content_style":"","_kad_post_vertical_padding":"","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"footnotes":""},"categories":[103],"tags":[102,101],"class_list":["post-2537","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-novas","tag-investigacion","tag-tratamentos"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>A UE revisa Zinbryta para a Esclerose M\u00faltiple por varios casos de trastornos cerebrais inflamatorios - FEGADEM<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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