{"id":3498,"date":"2021-06-23T09:54:53","date_gmt":"2021-06-23T12:54:53","guid":{"rendered":"https:\/\/politiciando.com.br\/?p=3498"},"modified":"2021-06-23T09:54:55","modified_gmt":"2021-06-23T12:54:55","slug":"medicamentos","status":"publish","type":"post","link":"https:\/\/politiciando.com.br\/?p=3498","title":{"rendered":"MEDICAMENTOS"},"content":{"rendered":"\n<h1 class=\"wp-block-heading\">Covid-19: negada autoriza\u00e7\u00e3o de uso emergencial do Avifavir<\/h1>\n\n\n\n    <!\u2014 INICIO TAG \u2014>\n     <!\u2014 \n     Id: 7400 \n     Campanha:  DETRAN S\u00c3O JO\u00c3O\n     Server: Metrike \n     Ve\u00edculo:  POLITICIANDO \n     Cliente: GOVPB   \n     Formato: POLITICIANDO - 300X250 \n     Data de Veicula\u00e7\u00e3o: 07\/06\/2021 - 30\/06\/2021\n     \u2014>\n     <ins data-revive-zoneid=\"7400\" data-revive-id=\"566f260197bf822e7263f1a3667caa2f\"><\/ins>\n     <script async src=\"\/\/ads.metrike.com\/asyncjs.php\"><\/script>\n     <!\u2014 FIM TAG \u2014>\n\n\n\n<figure class=\"wp-block-image size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/politiciando.com.br\/wp-content\/uploads\/2021\/06\/remedio.png\" alt=\"\" class=\"wp-image-3499\" width=\"1029\" height=\"575\" srcset=\"https:\/\/politiciando.com.br\/wp-content\/uploads\/2021\/06\/remedio.png 806w, https:\/\/politiciando.com.br\/wp-content\/uploads\/2021\/06\/remedio-300x167.png 300w, https:\/\/politiciando.com.br\/wp-content\/uploads\/2021\/06\/remedio-768x429.png 768w\" sizes=\"auto, (max-width: 1029px) 100vw, 1029px\" \/><\/figure>\n\n\n\n    <!\u2014 INICIO TAG \u2014>\n     <!\u2014 \n     Id: 7400 \n     Campanha:  DETRAN S\u00c3O JO\u00c3O\n     Server: Metrike \n     Ve\u00edculo:  POLITICIANDO \n     Cliente: GOVPB   \n     Formato: POLITICIANDO - 300X250 \n     Data de Veicula\u00e7\u00e3o: 07\/06\/2021 - 30\/06\/2021\n     \u2014>\n     <ins data-revive-zoneid=\"7400\" data-revive-id=\"566f260197bf822e7263f1a3667caa2f\"><\/ins>\n     <script async src=\"\/\/ads.metrike.com\/asyncjs.php\"><\/script>\n     <!\u2014 FIM TAG \u2014>\n\n\n\n   <!\u2014 INICIO TAG \u2014>\n     <!\u2014 \n     Id: 7399 \n     Campanha:  DETRAN S\u00c3O JO\u00c3O\n     Server: Metrike \n     Ve\u00edculo:  POLITICIANDO \n     Cliente: GOVPB   \n     Formato: POLITICIANDO - 728X90 \n     Data de Veicula\u00e7\u00e3o: 07\/06\/2021 - 30\/06\/2021\n     \u2014>\n     <ins data-revive-zoneid=\"7399\" data-revive-id=\"566f260197bf822e7263f1a3667caa2f\"><\/ins>\n     <script async src=\"\/\/ads.metrike.com\/asyncjs.php\"><\/script>\n     <!\u2014 FIM TAG \u2014>\n\n\n\n<p>Decis\u00e3o un\u00e2nime foi tomada durante a 12\u00aa Reuni\u00e3o P\u00fablica da Diretoria Colegiada (Dicol), nesta ter\u00e7a-feira (22\/6).<\/p>\n\n\n\n<p>Anvisa negou a autoriza\u00e7\u00e3o tempor\u00e1ria de uso emergencial do medicamento&nbsp;Avifavir&nbsp;(Favipiravir) para o tratamento antiviral de pacientes hospitalizados com Covid-19. A decis\u00e3o un\u00e2nime foi tomada durante a 12\u00aa Reuni\u00e3o P\u00fablica da Diretoria Colegiada (Dicol), nesta ter\u00e7a-feira (22\/6).&nbsp;<\/p>\n\n\n\n<p>&nbsp;De acordo com o voto da diretora&nbsp;Meiruze&nbsp;Freitas, relatora da pauta, o medicamento em quest\u00e3o n\u00e3o atende \u00e0s expectativas da Ag\u00eancia quanto aos requisitos m\u00ednimos de seguran\u00e7a e efic\u00e1cia no contexto do uso emergencial.&nbsp;<\/p>\n\n\n\n   <!\u2014 INICIO TAG \u2014>\n     <!\u2014 \n     Id: 7399 \n     Campanha:  DETRAN S\u00c3O JO\u00c3O\n     Server: Metrike \n     Ve\u00edculo:  POLITICIANDO \n     Cliente: GOVPB   \n     Formato: POLITICIANDO - 728X90 \n     Data de Veicula\u00e7\u00e3o: 07\/06\/2021 - 30\/06\/2021\n     \u2014>\n     <ins data-revive-zoneid=\"7399\" data-revive-id=\"566f260197bf822e7263f1a3667caa2f\"><\/ins>\n     <script async src=\"\/\/ads.metrike.com\/asyncjs.php\"><\/script>\n     <!\u2014 FIM TAG \u2014>\n\n\n\n   <!\u2014 INICIO TAG \u2014>\n     <!\u2014 \n     Id: 7399 \n     Campanha:  DETRAN S\u00c3O JO\u00c3O\n     Server: Metrike \n     Ve\u00edculo:  POLITICIANDO \n     Cliente: GOVPB   \n     Formato: POLITICIANDO - 728X90 \n     Data de Veicula\u00e7\u00e3o: 07\/06\/2021 - 30\/06\/2021\n     \u2014>\n     <ins data-revive-zoneid=\"7399\" data-revive-id=\"566f260197bf822e7263f1a3667caa2f\"><\/ins>\n     <script async src=\"\/\/ads.metrike.com\/asyncjs.php\"><\/script>\n     <!\u2014 FIM TAG \u2014>\n\n\n\n<p>&#8220;A Anvisa continua comprometida com o avan\u00e7o da sa\u00fade p\u00fablica do pa\u00eds durante esta pandemia sem precedentes. A Ag\u00eancia deve usar de todas as vias poss\u00edveis para fazer com que novos tratamentos estejam dispon\u00edveis para os pacientes o mais r\u00e1pido poss\u00edvel. Entretanto, n\u00e3o se pode autorizar o uso de um medicamento que n\u00e3o demonstrou benef\u00edcio cl\u00ednico no tratamento da Covid-19 e ainda pode resultar em riscos \u00e0 sa\u00fade dos pacientes&#8221;, afirmou a diretora relatora.&nbsp;<\/p>\n\n\n\n<p>O medicamento, fabricado pelas empresas russas API \u2013 Technologies LLC e Joint Stock&nbsp;Company&nbsp;Chemical&nbsp;Diversity&nbsp;Research&nbsp;Institute&nbsp;\u2013 JSC CDRI, teve a solicita\u00e7\u00e3o de autoriza\u00e7\u00e3o de uso emergencial (AUE) registrada pelo Instituto Vital&nbsp;Brazil.&nbsp;<\/p>\n\n\n\n<p>O&nbsp;Avifavir&nbsp;\u00e9 considerado um medicamento novo, com insumo farmac\u00eautico ativo (IFA) ainda n\u00e3o registrado pela Anvisa. No Brasil, at\u00e9 o momento, j\u00e1 possuem indica\u00e7\u00e3o para tratamento de Covid-19 o f\u00e1rmaco&nbsp;Rendesivir&nbsp;e duas associa\u00e7\u00f5es de anticorpos monoclonais, formadas pelo&nbsp;casirivimabe&nbsp;com o&nbsp;imdevimabe&nbsp;e pelo&nbsp;banlanivimabe&nbsp;com o&nbsp;etesevimabe.&nbsp;&nbsp;&nbsp;<\/p>\n\n\n\n<p>At\u00e9 o momento, nenhuma autoridade regulat\u00f3ria no mundo aprovou o&nbsp;Avifavir&nbsp;(Favipiravir) para o tratamento da Covid-19.&nbsp;<\/p>\n\n\n\n   <!\u2014 INICIO TAG \u2014>\n     <!\u2014 \n     Id: 7399 \n     Campanha:  DETRAN S\u00c3O JO\u00c3O\n     Server: Metrike \n     Ve\u00edculo:  POLITICIANDO \n     Cliente: GOVPB   \n     Formato: POLITICIANDO - 728X90 \n     Data de Veicula\u00e7\u00e3o: 07\/06\/2021 - 30\/06\/2021\n     \u2014>\n     <ins data-revive-zoneid=\"7399\" data-revive-id=\"566f260197bf822e7263f1a3667caa2f\"><\/ins>\n     <script async src=\"\/\/ads.metrike.com\/asyncjs.php\"><\/script>\n     <!\u2014 FIM TAG \u2014>\n\n\n\n<p><strong>Decis\u00e3o t\u00e9cnica&nbsp;<\/strong><\/p>\n\n\n\n<p>A decis\u00e3o da Anvisa \u00e9 fundamentada e sustentada em uma avalia\u00e7\u00e3o t\u00e9cnica que se orienta pela pondera\u00e7\u00e3o dos potenciais benef\u00edcios para a sa\u00fade p\u00fablica em compara\u00e7\u00e3o aos eventuais riscos sanit\u00e1rios decorrentes do uso do medicamento em avalia\u00e7\u00e3o.&nbsp;<\/p>\n\n\n\n<p>Ap\u00f3s essa avalia\u00e7\u00e3o, realizada pelas ger\u00eancias-gerais de Medicamentos e Produtos Biol\u00f3gicos (GGMED), de Fiscaliza\u00e7\u00e3o e Inspe\u00e7\u00e3o Sanit\u00e1ria (GGFIS) e de Monitoramento de Produtos Sujeitos \u00e0 Vigil\u00e2ncia Sanit\u00e1ria (GGMON), as \u00e1reas t\u00e9cnicas conclu\u00edram que as limita\u00e7\u00f5es, incertezas e riscos da aprova\u00e7\u00e3o do uso emergencial do&nbsp;Avifavir&nbsp;superam os benef\u00edcios no tratamento de pacientes com Covid-19.&nbsp;<\/p>\n\n\n\n<p>Alinhada \u00e0s manifesta\u00e7\u00f5es t\u00e9cnicas, a Diretoria Colegiada entendeu, por unanimidade, que o produto n\u00e3o atende \u00e0s expectativas da Ag\u00eancia quanto aos requisitos m\u00ednimos de seguran\u00e7a e efic\u00e1cia no contexto do uso emergencial.&nbsp;<\/p>\n\n\n\n<p>\u00c9 importante ressaltar que a avalia\u00e7\u00e3o de pedidos dessa natureza \u00e9 realizada com base na&nbsp;<a href=\"https:\/\/www.in.gov.br\/en\/web\/dou\/-\/lei-n-14.124-de-10-de-marco-de-2021-307745858\" rel=\"noreferrer noopener\" target=\"_blank\">Lei 14.124\/2021<\/a>, que estabelece as regras para autoriza\u00e7\u00e3o de uso emergencial, de forma tempor\u00e1ria e em car\u00e1ter experimental, de vacinas e de medicamentos contra a Covid-19. A regulamenta\u00e7\u00e3o da Anvisa a esse respeito est\u00e1 contida na&nbsp;<a href=\"http:\/\/antigo.anvisa.gov.br\/legislacao#\/visualizar\/445541\" rel=\"noreferrer noopener\" target=\"_blank\">Resolu\u00e7\u00e3o da Diretoria Colegiada (RDC) 475\/2021<\/a>&nbsp;e no&nbsp;<a href=\"http:\/\/antigo.anvisa.gov.br\/legislacao#\/visualizar\/450282\" rel=\"noreferrer noopener\" target=\"_blank\">Guia 49\/2021<\/a>.&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Covid-19: negada autoriza\u00e7\u00e3o de uso emergencial do Avifavir Decis\u00e3o un\u00e2nime foi tomada durante a 12\u00aa Reuni\u00e3o P\u00fablica da Diretoria Colegiada<\/p>\n","protected":false},"author":1,"featured_media":3499,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"colormag_page_container_layout":"default_layout","colormag_page_sidebar_layout":"default_layout","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[47],"tags":[],"class_list":["post-3498","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-saude"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v16.3 - 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