Le Comit\u00e9 des m\u00e9dicaments \u00e0 usage v\u00e9t\u00e9rinaire (CVMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments a adopt\u00e9 plusieurs avis relatifs \u00e0 des autorisations de mise sur le march\u00e9 (AMM), des r\u00e9examens et des proc\u00e9dures de pharmacovigilance concernant des m\u00e9dicaments v\u00e9t\u00e9rinaires dans l\u2019Union europ\u00e9enne.<\/p>\n
Le CVMP a rendu un avis positif, dans le cadre de circonstances exceptionnelles, pour une AMM de Bovilis Lumpyvax, vaccin vivant contre la dermatose nodulaire contagieuse, destin\u00e9 \u00e0 l\u2019immunisation active des bovins afin de r\u00e9duire les signes cliniques et la vir\u00e9mie li\u00e9s au virus de cette maladie. Il a \u00e9galement adopt\u00e9 un avis positif pour une AMM de Stemyca, m\u00e9dicament \u00e0 base de cellules souches m\u00e9senchymateuses issues du cordon ombilical \u00e9quin, indiqu\u00e9 pour la r\u00e9duction des signes cliniques d\u2019ent\u00e9ropathie inflammatoire chronique non li\u00e9e \u00e0 l\u2019alimentation chez le chien. Par ailleurs, une variation pour le m\u00e9dicament Mirataz (mirtazapine) a \u00e9t\u00e9 approuv\u00e9e afin de mettre \u00e0 jour les informations sur le produit, \u00e0 la suite de nouvelles donn\u00e9es de s\u00e9curit\u00e9 d\u2019emploi chez l\u2019animal cible : le r\u00e9sum\u00e9 des caract\u00e9ristiques du produit (RCP) et la notice doivent d\u00e9sormais pr\u00e9ciser qu\u2019un surdosage peut \u00eatre associ\u00e9 \u00e0 certains effets ind\u00e9sirables d\u00e9j\u00e0 connus, notamment \u00e9ryth\u00e8me et alop\u00e9cie au site d\u2019application.<\/p>\n
Dans le cadre des AMM accord\u00e9es dans des circonstances exceptionnelles, le Comit\u00e9 a adopt\u00e9 un avis positif lors du r\u00e9examen du vaccin Vaxxitek HVT+IBD+H5 contre l\u2019influenza aviaire. Il a recommand\u00e9 de prolonger d\u2019un an la validit\u00e9 de cette AMM exceptionnelle.<\/p>\n
S\u2019agissant des proc\u00e9dures de renvoi au niveau de l\u2019Union, le CVMP a conclu l\u2019examen d\u2019une variation pour Vetmedin 1,5 mg\/ml solution orale pour chiens (pimobendane). En l\u2019absence de consensus entre \u00c9tats membres au sein du groupe de coordination pour la reconnaissance mutuelle et les proc\u00e9dures d\u00e9centralis\u00e9es en mati\u00e8re v\u00e9t\u00e9rinaire (CMDv) sur une nouvelle indication pour des raisons d\u2019efficacit\u00e9, la Commission europ\u00e9enne a sollicit\u00e9 des clarifications aupr\u00e8s du CVMP, sur la base de l\u2019article 54(8) du r\u00e8glement (UE) 2019\/6. Apr\u00e8s examen des donn\u00e9es disponibles, le CVMP a conclu, \u00e0 la majorit\u00e9, que le rapport b\u00e9n\u00e9fice\/risque de Vetmedin pour l\u2019indication propos\u00e9e est positif. Ses clarifications seront transmises \u00e0 la Commission europ\u00e9enne pour d\u00e9cision.<\/p>\n
Le Comit\u00e9 a par ailleurs adopt\u00e9 deux avis scientifiques portant sur un m\u00e9dicament pharmaceutique et un m\u00e9dicament immunologique, tous deux destin\u00e9s au saumon de l\u2019Atlantique. Concernant les march\u00e9s limit\u00e9s au sens de l\u2019article 23 du r\u00e8glement (UE) 2019\/6, le CVMP a class\u00e9, \u00e0 la suite d\u2019une demande, un produit antiparasitaire pour chiens (produits antiparasitaires, insecticides et r\u00e9pulsifs selon la classification ATCvet) comme destin\u00e9 \u00e0 un march\u00e9 restreint et non \u00e9ligible \u00e0 une autorisation au titre de cet article.<\/p>\n
En mati\u00e8re de pharmacovigilance, le Comit\u00e9 a adopt\u00e9 les r\u00e9sultats du traitement des signaux de s\u00e9curit\u00e9 pour la p\u00e9riode consid\u00e9r\u00e9e. Les signaux soumis par les titulaires d\u2019AMM sont publi\u00e9s, par ordre chronologique, sur le portail public IRIS, dans la liste des signaux de gestion de la pharmacovigilance v\u00e9t\u00e9rinaire, accessible via le filtre \u00ab Signal management submission \u00bb dans la cat\u00e9gorie \u00ab Submission type \u00bb. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le Comit\u00e9 des m\u00e9dicaments \u00e0 usage v\u00e9t\u00e9rinaire (CVMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments a adopt\u00e9 plusieurs avis relatifs \u00e0 des autorisations de mise sur le march\u00e9 (AMM), des r\u00e9examens et […]<\/p>\n","protected":false},"author":1,"featured_media":17698,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[31,2],"tags":[257,227,226],"class_list":["post-20465","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-politiques-europeennes-sante-social-travail","category-sante-publique-et-systeme-de-soins","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20465","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=20465"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20465\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17698"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=20465"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20465"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20465"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}