{"id":467024,"date":"2026-09-25T10:54:03","date_gmt":"2026-09-25T13:54:03","guid":{"rendered":"https:\/\/mrnews.com.br\/index.php\/2026\/09\/25\/anvisa-proibe-lotes-irregulares-de-medicamento-para-esclerose-multipla\/"},"modified":"2026-09-25T10:54:03","modified_gmt":"2026-09-25T13:54:03","slug":"anvisa-proibe-lotes-irregulares-de-medicamento-para-esclerose-multipla","status":"publish","type":"post","link":"https:\/\/mrnews.com.br\/index.php\/2026\/09\/25\/anvisa-proibe-lotes-irregulares-de-medicamento-para-esclerose-multipla\/","title":{"rendered":"Anvisa pro\u00edbe lotes irregulares de medicamento para esclerose m\u00faltipla"},"content":{"rendered":"<p>Por EBC, <\/p>\n<div>\n<p>A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) determinou a apreens\u00e3o de dois lotes do medicamento Ocrevus (ocrelizumabe) 300 mg\/10 ml. Os lotes s\u00e3o o H7953B14 e o H7953B06. A resolu\u00e7\u00e3o foi publicada nesta sexta-feira (25) no <em>Di\u00e1rio Oficial da Uni\u00e3o<\/em>.<\/p>\n<p><strong>O Ocrevus teve o registro aprovado pela Anvisa em 2022 e \u00e9 indicado para tratamento de pacientes com as formas recorrentes de esclerose m\u00faltipla e esclerose m\u00faltipla progressiva prim\u00e1ria.<\/strong><\/p>\n<p>Em nota, a Anvisa informou que os produtos foram distribu\u00eddos em julho pela Laf Med Distribuidora de Medicamentos e Materiais Hospitalares Ltda. e que a empresa n\u00e3o est\u00e1 autorizada a atuar no mercado farmac\u00eautico, incluindo o ato de distribuir, comercializar ou importar medicamentos.<\/p>\n<p><strong>A chamada Autoriza\u00e7\u00e3o de Funcionamento (AFE) da empresa, de acordo com a ag\u00eancia, est\u00e1 inativa desde outubro de 2025.<\/strong><\/p>\n<blockquote>\n<p>\u201cApesar de os produtos terem sido regularmente fabricados pela empresa detentora do registro do medicamento, esses lotes eram destinados a outros pa\u00edses e n\u00e3o ao Brasil\u201d, informou a nota.<\/p>\n<\/blockquote>\n<p>\u201cDessa forma, n\u00e3o \u00e9 poss\u00edvel garantir que tenham sido mantidas as condi\u00e7\u00f5es sanit\u00e1rias necess\u00e1rias \u00e0 conserva\u00e7\u00e3o e \u00e0 integridade do medicamento ao longo de toda a cadeia de distribui\u00e7\u00e3o at\u00e9 sua entrada no pa\u00eds, ocorrida de forma irregular\u201d, completou.<\/p>\n<p><strong>Al\u00e9m da apreens\u00e3o dos lotes, a medida pro\u00edbe o armazenamento, a venda, a distribui\u00e7\u00e3o, a exporta\u00e7\u00e3o, a importa\u00e7\u00e3o, a propaganda e o transporte do produto.\u00a0<\/strong><\/p>\n<blockquote>\n<p>\u201cSomente os dois lotes est\u00e3o proibidos por terem origem irregular\u201d, refor\u00e7ou a Anvisa.<\/p>\n<\/blockquote>\n<h2>Falsifica\u00e7\u00e3o<\/h2>\n<p>Ainda de acordo com a ag\u00eancia, a empresa Laf Med Distribuidora de Medicamentos e Materiais Hospitalares Ltda j\u00e1 havia sido autuada por causa\u00a0da distribui\u00e7\u00e3o de medicamentos falsificados. \u201cNa ocasi\u00e3o, o caso foi encaminhado \u00e0s autoridades policiais\u201d.<\/p>\n<p>A <strong>Ag\u00eancia Brasil<\/strong> entrou em contato com a Laf Med Distribuidora de Medicamentos e Materiais Hospitalares Ltda. e aguarda posicionamento.<\/p>\n<h2>Medicamentos manipulados<\/h2>\n<p><strong>A resolu\u00e7\u00e3o da Anvisa tamb\u00e9m determina o recolhimento de todos os medicamentos manipulados est\u00e9reis produzidos pela empresa ICT Farmac\u00eautica Ltda. no per\u00edodo de 31 de agosto a 2 de setembro de 2026. A medida suspende a venda, distribui\u00e7\u00e3o, manipula\u00e7\u00e3o e \u00a0divulga\u00e7\u00e3o dos produtos.<\/strong><\/p>\n<p>\u201cForam constatadas defici\u00eancias cr\u00edticas nas instala\u00e7\u00f5es, utilidades, qualifica\u00e7\u00e3o de sistemas, monitoramento ambiental, processos ass\u00e9pticos, valida\u00e7\u00e3o de esteriliza\u00e7\u00e3o, filtra\u00e7\u00e3o esterilizante, integridade de recipientes e sistema de garantia da qualidade, comprometendo a garantia da esterilidade, qualidade, seguran\u00e7a e efic\u00e1cia das prepara\u00e7\u00f5es manipuladas\u201d, informou a nota.<\/p>\n<p>A <strong>Ag\u00eancia Brasil<\/strong> entrou em contato com a ICT Farmac\u00eautica Ltda. e aguarda posicionamento.<\/p>\n<p>      <!-- Relacionada --><\/p>\n<p>            <!-- Relacionada -->\n    <\/div>\n","protected":false},"excerpt":{"rendered":"<p>Por EBC, A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) determinou a apreens\u00e3o de dois lotes do medicamento Ocrevus (ocrelizumabe) 300 mg\/10 ml. Os lotes s\u00e3o o H7953B14 e o H7953B06. A resolu\u00e7\u00e3o foi publicada nesta sexta-feira (25) no Di\u00e1rio Oficial da Uni\u00e3o. O Ocrevus teve o registro aprovado pela Anvisa em 2022 e \u00e9 indicado &hellip;<\/p>\n","protected":false},"author":39,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[4],"tags":[],"class_list":["post-467024","post","type-post","status-publish","format-standard","hentry","category-servicos"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Anvisa pro\u00edbe lotes irregulares de medicamento para esclerose m\u00faltipla<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/agenciabrasil.ebc.com.br\/saude\/noticia\/2026-09\/anvisa-proibe-lotes-irregulares-de-medicamento-para-esclerose-multipla\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Anvisa pro\u00edbe lotes irregulares de medicamento para esclerose m\u00faltipla\" \/>\n<meta property=\"og:description\" content=\"Por EBC, A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) determinou a apreens\u00e3o de dois lotes do medicamento Ocrevus (ocrelizumabe) 300 mg\/10 ml. Os lotes s\u00e3o o H7953B14 e o H7953B06. A resolu\u00e7\u00e3o foi publicada nesta sexta-feira (25) no Di\u00e1rio Oficial da Uni\u00e3o. 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