{"id":4887,"date":"2017-01-17T08:52:59","date_gmt":"2017-01-17T11:52:59","guid":{"rendered":"https:\/\/prodoctor.net\/blog\/?p=4887"},"modified":"2021-06-17T14:49:38","modified_gmt":"2021-06-17T17:49:38","slug":"registrado-primeiro-medicamento-base-de-cannabis-sativa","status":"publish","type":"post","link":"https:\/\/prodoctor.net\/blog\/registrado-primeiro-medicamento-base-de-cannabis-sativa\/","title":{"rendered":"Registrado primeiro medicamento \u00e0 base de Cannabis sativa"},"content":{"rendered":"<p>A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) <strong>aprovou o registro do medicamento espec\u00edfico Mevatyl\u00ae<\/strong> (tetraidrocanabinol (THC), 27 mg\/mL + canabidiol (CBD), 25 mg\/mL), canabinoides <strong>obtidos a partir da Cannabis sativa<\/strong>, na forma farmac\u00eautica solu\u00e7\u00e3o oral (spray). <strong>\u00c9 o primeiro medicamento registrado no pa\u00eds<\/strong> \u00e0 base de Cannabis Sativa.<\/p>\n<p>O <strong>novo medicamento Mevatyl\u00ae<\/strong>, registrado em outros pa\u00edses com o nome comercial Sativex\u00ae, <strong>\u00e9 indicado para o tratamento sintom\u00e1tico<\/strong> da espasticidade moderada a grave relacionada \u00e0 <strong>esclerose m\u00faltipla<\/strong>, sendo destinado a pacientes adultos n\u00e3o responsivos a outros medicamentos antiesp\u00e1sticos e que demonstram melhoria clinicamente significativa dos sintomas relacionados \u00e0 espasticidade durante um per\u00edodo inicial de tratamento com o Mevatyl\u00ae. O medicamento <strong>\u00e9 destinado ao uso em adi\u00e7\u00e3o \u00e0 medica\u00e7\u00e3o antiesp\u00e1stica<\/strong> <strong>atual<\/strong> do paciente e est\u00e1 <strong>aprovado em outros 28 pa\u00edses<\/strong>, incluindo Canad\u00e1, Estados Unidos, Alemanha, Dinamarca, Su\u00e9cia, Su\u00ed\u00e7a e Israel.<\/p>\n<p>Mevatyl\u00ae <strong>n\u00e3o \u00e9 indicado para o tratamento de epilepsia<\/strong>, pois o THC, uma de suas subst\u00e2ncias ativas, <strong>possui potencial de causar agravamento de crises epil\u00e9ticas<\/strong>. O medicamento <strong>tamb\u00e9m n\u00e3o \u00e9 recomendado para uso em crian\u00e7as e adolescentes<\/strong> com menos de 18 anos de idade devido \u00e0 aus\u00eancia de dados de seguran\u00e7a e efic\u00e1cia para pacientes nesta faixa et\u00e1ria.<\/p>\n<p>Conforme dados de estudos cl\u00ednicos realizados com Mevatyl\u00ae <strong>a ocorr\u00eancia de depend\u00eancia com o seu uso \u00e9 improv\u00e1vel<\/strong>. Mevatyl\u00ae ser\u00e1 <strong>comercializado com tarja preta<\/strong> em sua rotulagem e a <strong>sua dispensa\u00e7\u00e3o ficar\u00e1 sujeita a prescri\u00e7\u00e3o m\u00e9dica<\/strong> por meio de notifica\u00e7\u00e3o de receita A prevista na Portaria SVS\/MS n\u00ba 344\/1998 e de Termo de Consentimento Informado ao Paciente.<\/p>\n<p>O medicamento<strong> ser\u00e1 fabricado por GW Pharma Limited<\/strong> \u2013 Reino Unido, e a detentora do <strong>registro do medicamento no Brasil \u00e9 a empresa Beaufour Ipsen Farmac\u00eautica Ltda<\/strong>., localizada em S\u00e3o Paulo (SP). <strong>Maiores detalhes podem ser obtidos por meio da Nota T\u00e9cnica<\/strong> elaborada pela \u00e1rea de<a href=\"http:\/\/portal.anvisa.gov.br\/documents\/33836\/351923\/NT++01+-+2017+-+Mevatyl.pdf\/4e02e67a-34b6-48d6-9c34-d0aa4a5dd1fd\"> registro de medicamentos espec\u00edficos<\/a>, GMESP\/GGMED.<\/p>\n<h3>O que \u00e9 um medicamento espec\u00edfico?<\/h3>\n<p>O termo \u201cmedicamento espec\u00edfico\u201d <strong>aplica-se a produtos farmac\u00eauticos<\/strong>, tecnicamente obtidos ou elaborados, <strong>com finalidade profil\u00e1tica<\/strong>, curativa ou paliativa <strong>n\u00e3o enquadrados nas categorias de medicamento<\/strong> novo, gen\u00e9rico, similar, biol\u00f3gico, fitoter\u00e1pico ou notificado e cuja(s) subst\u00e2ncia(s) ativa(s), independente da natureza ou origem, <strong>n\u00e3o \u00e9 pass\u00edvel de ensaio de bioequival\u00eancia<\/strong>, frente a um produto comparador.<\/p>\n<p>A resolu\u00e7\u00e3o RDC 24\/2011 define os produtos que se enquadram na categoria de medicamentos espec\u00edficos e <strong>dentre eles est\u00e3o os fitof\u00e1rmacos, caso do medicamento Mevatyl\u00ae<\/strong>. Os <strong>fitof\u00e1rmacos<\/strong> s\u00e3o <strong>subst\u00e2ncias purificadas e isoladas<\/strong> a partir de mat\u00e9ria-prima vegetal com estrutura qu\u00edmica definida e atividade farmacol\u00f3gica. S\u00e3o empregados como ativos em <strong>medicamentos com propriedade profil\u00e1tica, paliativa ou curativa<\/strong>. N\u00e3o s\u00e3o considerados fitof\u00e1rmacos compostos isolados que sofram qualquer etapa de semis\u00edntese ou modifica\u00e7\u00e3o de sua estrutura qu\u00edmica.<\/p>\n<p>Fonte: Anvisa&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) aprovou o registro do medicamento espec\u00edfico Mevatyl\u00ae (tetraidrocanabinol (THC), 27 mg\/mL +&#8230;<\/p>\n","protected":false},"author":3,"featured_media":19864,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_kadence_starter_templates_imported_post":false,"_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":[415],"tags":[],"class_list":["post-4887","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicamentos-e-farmacia"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Registrado primeiro medicamento \u00e0 base de Cannabis 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