{"id":18261,"date":"2024-12-05T12:31:21","date_gmt":"2024-12-05T11:31:21","guid":{"rendered":"https:\/\/www.dopharma.com\/?page_id=18261"},"modified":"2025-04-25T15:43:04","modified_gmt":"2025-04-25T13:43:04","slug":"pharmacovigilance","status":"publish","type":"page","link":"https:\/\/www.dopharma.com\/fr\/service-support\/pharmacovigilance\/","title":{"rendered":"Pharmacovigilance"},"content":{"rendered":"<div class=\"row\"  id=\"row-671249310\">\n\n\t<div id=\"col-1882607928\" class=\"col medium-2 small-12 large-2\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1007405186\" class=\"col medium-8 small-12 large-8\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<p><main class=\"template-page content  av-content-full alpha units\" role=\"main\"><\/p>\n<div class=\"post-entry post-entry-type-page post-entry-66\">\n<div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column av-f4xn6-d71556238fb1dc102a29c18ad45a0189 av_one_full  avia-builder-el-1  el_before_av_hr  avia-builder-el-first  first flex_column_div av-zero-column-padding\">\n<section class=\"av_textblock_section av-eq3b2-3b855aa7117b70371949c982ead63f4a\">\n<div class=\"avia_textblock\">\n<h1><span style=\"color: #00aae7;\">Pharmacovigilance<\/span><\/h1>\n<\/div>\n<\/section>\n<\/div>\n<\/div>\n<\/div>\n<p><\/main><\/p>\n<h3 class=\"thin-font\">Prot\u00e9ger la sant\u00e9 animale<\/h3>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-140556536\" class=\"col medium-2 small-12 large-2\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1017383043\">\n\n\t<div id=\"col-1426913887\" class=\"col medium-2 small-12 large-2\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-170716294\" class=\"col medium-8 small-12 large-8\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"flex_column av-daitq-7b30da903536ccf3dc1c4bc6bb4ad85c av_two_third  avia-builder-el-4  el_after_av_hr  el_before_av_one_third  first flex_column_div av-zero-column-padding\">\n<section class=\"av_textblock_section av-cnqua-16cff5c1c6147cf9cc9f567bb75b457b\">\n<div class=\"avia_textblock\">\n<h2>Qu'est-ce que la pharmacovigilance ?<\/h2>\n<p>L\u2019objectif principal de la pharmacovigilance est de surveiller et de garantir la s\u00e9curit\u00e9 et l\u2019efficacit\u00e9 des m\u00e9dicaments (v\u00e9t\u00e9rinaires) apr\u00e8s leur autorisation de mise sur le march\u00e9. La pharmacovigilance repose sur une collaboration entre les autorit\u00e9s, l\u2019industrie, les v\u00e9t\u00e9rinaires et les utilisateurs. Un produit s\u00fbr et efficace est dans l\u2019int\u00e9r\u00eat de tous.<\/p>\n<p>Il est g\u00e9n\u00e9ralement admis que l\u2019utilisation de tout m\u00e9dicament (v\u00e9t\u00e9rinaire) comporte certains risques. Ces risques doivent toutefois \u00eatre \u00e9quilibr\u00e9s par les b\u00e9n\u00e9fices attendus de l\u2019utilisation du produit : c\u2019est ce que l\u2019on appelle l\u2019\u00e9quilibre b\u00e9n\u00e9fice-risque. Lors de l\u2019enregistrement, cet \u00e9quilibre est \u00e9valu\u00e9 pour la premi\u00e8re fois. La s\u00e9curit\u00e9 et l\u2019efficacit\u00e9 du produit sont alors \u00e9tudi\u00e9es de mani\u00e8re approfondie.<\/p>\n<p>Apr\u00e8s l\u2019enregistrement, cet \u00e9quilibre est suppos\u00e9 se maintenir. Cependant, malgr\u00e9 des \u00e9tudes pr\u00e9alables rigoureuses, des effets ind\u00e9sirables inattendus peuvent survenir une fois que le m\u00e9dicament v\u00e9t\u00e9rinaire est mis sur le march\u00e9. C\u2019est en effet la premi\u00e8re fois que le produit est utilis\u00e9 \u00e0 grande \u00e9chelle, dans une grande diversit\u00e9 de situations. Et m\u00eame lorsqu\u2019un m\u00e9dicament v\u00e9t\u00e9rinaire est sur le march\u00e9 depuis longtemps, des \u00e9v\u00e9nements inattendus peuvent encore appara\u00eetre, par exemple si les conditions d\u2019utilisation \u00e9voluent ou en cas d\u2019interaction avec un nouveau produit.<\/p>\n<\/div>\n<\/section>\n<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1804032940\" class=\"col medium-2 small-12 large-2\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\n\t<section class=\"section\" id=\"section_341689395\">\n\t\t<div class=\"section-bg fill\" >\n\t\t\t\t\t\t\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n<div class=\"row align-center\"  id=\"row-1561038298\">\n\n\t<div id=\"col-2051478246\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner text-center\"  >\n\t\t\t\n\t\t\t\n<h2>Comment signaler un cas de pharmacovigilance ?<\/h2>\n<div class=\"template-page content  av-content-full alpha units\">\n<div class=\"post-entry post-entry-type-page post-entry-66\">\n<div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column av-2822m-2691808b6851647d0a605d277eeb8302 av_one_full  avia-builder-el-9  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding\">\n<section class=\"av_textblock_section av-1s2ly-77e2e14826c9b5eb35f84a28058cb2db\">\n<div class=\"avia_textblock\">\n<p>La plupart des autorit\u00e9s nationales offrent la possibilit\u00e9 de d\u00e9clarer un cas directement aupr\u00e8s d\u2019elles, mais vous pouvez \u00e9galement vous adresser au titulaire de l\u2019autorisation de mise sur le march\u00e9 ou \u00e0 son repr\u00e9sentant.<\/p>\n<p>Pour nous signaler un cas, vous pouvez remplir notre formulaire de pharmacovigilance, ou nous contacter par t\u00e9l\u00e9phone <a href=\"mailto:pharmacovigilance@dopharma.com\">ou par courriel<\/a>.<\/p>\n<\/div>\n<\/section>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-2003749725\">\n\n\t<div id=\"col-783947572\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/www.dopharma.com\/wp-content\/uploads\/2025\/04\/Formulier-bijwerkingen-Dopharma-Research-RF-904v10.pdf\" target=\"_blank\" class=\"button primary\" rel=\"noopener\" >\n\t\t<span>T\u00e9l\u00e9charger le formulaire (NL)<\/span>\n\t<i class=\"icon-angle-right\" aria-hidden=\"true\"><\/i><\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1378684089\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/www.dopharma.com\/wp-content\/uploads\/2025\/04\/Adverse-event-reporting-Dopharma-RF906-9.pdf\" target=\"_blank\" class=\"button primary\" rel=\"noopener\" >\n\t\t<span>T\u00e9l\u00e9charger le formulaire (EN)<\/span>\n\t<i class=\"icon-angle-right\" aria-hidden=\"true\"><\/i><\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-495336933\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/www.dopharma.com\/wp-content\/uploads\/2025\/04\/Signalisation-effets-indesirables-Dopharma-RF914-4.pdf\" target=\"_blank\" class=\"button primary\" rel=\"noopener\" >\n\t\t<span>T\u00e9l\u00e9charger le formulaire (FR)<\/span>\n\t<i class=\"icon-angle-right\" aria-hidden=\"true\"><\/i><\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1211777136\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/www.dopharma.com\/wp-content\/uploads\/2025\/04\/Adverse-event-reporting-Dopharma-IT-based-on-RF906-8-R01.pdf\" target=\"_blank\" class=\"button primary\" rel=\"noopener\" >\n\t\t<span>T\u00e9l\u00e9charger le formulaire (IT)<\/span>\n\t<i class=\"icon-angle-right\" aria-hidden=\"true\"><\/i><\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1791925743\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/www.dopharma.com\/wp-content\/uploads\/2025\/04\/Formulario-Eventos-Adversos-Dopharma-obv-RF906-9.pdf\" target=\"_blank\" class=\"button primary\" rel=\"noopener\" >\n\t\t<span>T\u00e9l\u00e9charger le formulaire (ES)<\/span>\n\t<i class=\"icon-angle-right\" aria-hidden=\"true\"><\/i><\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\n\t\t\n<style>\n#section_341689395 {\n  padding-top: 60px;\n  padding-bottom: 60px;\n  min-height: 300px;\n  background-color: rgb(234, 245, 249);\n}\n<\/style>\n\t<\/section>\n\t\n\n\t<section class=\"section\" id=\"section_607290535\">\n\t\t<div class=\"section-bg fill\" >\n\t\t\t\t\t\t\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n<div class=\"row\"  id=\"row-212372553\">\n\n\t<div id=\"col-1108918490\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_808870461\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"300\" src=\"https:\/\/www.dopharma.com\/wp-content\/uploads\/2025\/02\/Safety-First-sign-300x300-1.png\" class=\"attachment-large size-large\" alt=\"\" srcset=\"https:\/\/www.dopharma.com\/wp-content\/uploads\/2025\/02\/Safety-First-sign-300x300-1.png 300w, https:\/\/www.dopharma.com\/wp-content\/uploads\/2025\/02\/Safety-First-sign-300x300-1-100x100.png 100w, https:\/\/www.dopharma.com\/wp-content\/uploads\/2025\/02\/Safety-First-sign-300x300-1-80x80.png 80w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n<style>\n#image_808870461 {\n  width: 100%;\n}\n<\/style>\n\t<\/div>\n\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1622626212\" class=\"col medium-8 small-12 large-8\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"flex_column av-90u6q-2fcecef15f10352e4f6ce45b5ccedbbc av_two_third  avia-builder-el-15  el_after_av_one_third  avia-builder-el-last  flex_column_div av-zero-column-padding\">\n<section class=\"av_textblock_section av-unlm-fecace2f579808919a1b878eb6fdb6ec\">\n<div class=\"avia_textblock\">\n<h2><span style=\"color: #00aae7;\">Qu'est-ce qui rel\u00e8ve de la pharmacovigilance ?<\/span><\/h2>\n<p>La pharmacovigilance ne concerne pas uniquement les effets ind\u00e9sirables chez les animaux trait\u00e9s. Les types d\u2019\u00e9v\u00e9nements suivants rel\u00e8vent tous du champ d\u2019application de la pharmacovigilance :<\/p>\n<ul>\n<li>effets ind\u00e9sirables chez les animaux, y compris en cas d\u2019utilisation hors AMM ;<\/li>\n<li>effets ind\u00e9sirables chez l\u2019homme ;<\/li>\n<li>absence de l\u2019efficacit\u00e9 attendue ;<\/li>\n<li>validit\u00e9 du d\u00e9lai d\u2019attente ;<\/li>\n<li>effets inattendus sur l\u2019environnement ;<\/li>\n<li>transmission d\u2019agents infectieux.<\/li>\n<\/ul>\n<\/div>\n<\/section>\n<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\n\t\t\n<style>\n#section_607290535 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n}\n<\/style>\n\t<\/section>\n\t\n\n\t<section class=\"section\" id=\"section_808010917\">\n\t\t<div class=\"section-bg fill\" >\n\t\t\t\t\t\t\t\t\t\n\t\t\t\n\t<div class=\"is-border\"\n\t\tstyle=\"border-color:rgb(235, 235, 235);border-width:1px 0px 0px 0px;\">\n\t<\/div>\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n<div class=\"row\"  id=\"row-1944891540\">\n\n\t<div id=\"col-946800912\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"flex_column av-77ebm-2133266bf09e5110078d8d0c5db55824 av_two_third  avia-builder-el-18  el_before_av_one_third  avia-builder-el-first  first flex_column_div av-zero-column-padding\">\n<section class=\"av_textblock_section av-2iva-c2da63d7a394f3a9297125b6487a093b\">\n<div class=\"avia_textblock\">\n<h2><span style=\"color: #ffffff;\">Qu'attend-on de vous ?<\/span><\/h2>\n<p><span style=\"color: #ffffff;\">Comme mentionn\u00e9 pr\u00e9c\u00e9demment, la pharmacovigilance repose sur un effort collectif. Sans retour d\u2019information provenant du terrain, les probl\u00e8mes potentiels ne seront port\u00e9s \u00e0 la connaissance des autorit\u00e9s ou de l\u2019industrie que tardivement, voire pas du tout.<\/span><\/p>\n<p><span style=\"color: #ffffff;\">C\u2019est pourquoi il est attendu de vous que vous signaliez tout effet ind\u00e9sirable suspect\u00e9. Plus les informations transmises sont nombreuses et d\u00e9taill\u00e9es, plus l\u2019\u00e9valuation du cas sera pertinente.<\/span><\/p>\n<p><span style=\"color: #ffffff;\">Sur la base des donn\u00e9es disponibles, chaque d\u00e9claration est analys\u00e9e afin d\u2019estimer la probabilit\u00e9 d\u2019un lien de causalit\u00e9 entre l\u2019\u00e9v\u00e9nement signal\u00e9 et le(s) m\u00e9dicament(s) v\u00e9t\u00e9rinaire(s) concern\u00e9(s).\u00a0<\/span><\/p>\n<p><span style=\"color: #ffffff;\">Si les informations fournies sont incompl\u00e8tes ou insuffisamment pr\u00e9cises, le cas sera class\u00e9 comme non concluant. Ainsi, pour que votre signalement ait un r\u00e9el impact, prenez le temps de fournir un maximum d\u2019informations.<\/span><\/p>\n<\/div>\n<\/section>\n<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1580474248\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2><span style=\"color: #ffffff;\">Pourquoi la pharmacovigilance est-elle importante ?<\/span><\/h2>\n<p><span style=\"color: #ffffff;\">Les connaissances issues de la pharmacovigilance permettent de maintenir une image pr\u00e9cise et actualis\u00e9e du profil de s\u00e9curit\u00e9 et d\u2019efficacit\u00e9 de chaque produit autoris\u00e9.<\/span><\/p>\n<p><span style=\"color: #ffffff;\">En l\u2019absence de d\u00e9clarations d\u2019effets ind\u00e9sirables, l\u2019industrie et les autorit\u00e9s consid\u00e8rent que le produit est s\u00fbr et efficace lorsqu\u2019il est utilis\u00e9 conform\u00e9ment au RCP. Sans signalement, aucun \u00e9l\u00e9ment ne permettra de d\u00e9clencher une enqu\u00eate ou d\u2019envisager une modification.<\/span><\/p>\n<p><span style=\"color: #ffffff;\">Pour \u00e9valuer correctement si l\u2019\u00e9quilibre b\u00e9n\u00e9fice-risque d\u2019un produit reste inchang\u00e9, chaque information relative \u00e0 la substance active ou au produit compte. Chaque d\u00e9claration contribue \u00e0 enrichir ces connaissances.<\/span><\/p>\n<p><span style=\"color: #ffffff;\">Bien entendu, nous pr\u00e9f\u00e9rons toujours comprendre pr\u00e9cis\u00e9ment pourquoi un effet ind\u00e9sirable s\u2019est produit, mais cela s\u2019av\u00e8re parfois impossible. Toutefois, le simple fait d\u2019analyser le cas am\u00e9liore d\u00e9j\u00e0 le niveau de connaissance des parties prenantes. La d\u00e9tection de signaux constitue \u00e9galement un volet essentiel de la pharmacovigilance.<\/span><\/p>\n<p><span style=\"color: #ffffff;\">Un seul signalement ne d\u00e9clenchera probablement pas d\u2019alerte, mais plusieurs rapports similaires y parviendront tr\u00e8s probablement. De ce point de vue, chaque cas est important.<\/span><\/p>\n<p>\u00a0<\/p>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\n\t\t\n<style>\n#section_808010917 {\n  padding-top: 60px;\n  padding-bottom: 60px;\n  min-height: 300px;\n  background-color: #00aae2;\n}\n<\/style>\n\t<\/section>","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":18255,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-blank.php","meta":{"footnotes":""},"class_list":["post-18261","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Pharmacovigilance - Dopharma<\/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:\/\/www.dopharma.com\/fr\/service-support\/pharmacovigilance\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharmacovigilance - Dopharma\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.dopharma.com\/fr\/service-support\/pharmacovigilance\/\" \/>\n<meta property=\"og:site_name\" content=\"Dopharma\" \/>\n<meta property=\"article:modified_time\" content=\"2025-04-25T13:43:04+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.dopharma.com\/wp-content\/uploads\/2025\/05\/Dopharma-Raamsdonksveer-Aerial-Photo.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1079\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.dopharma.com\\\/en\\\/service-support\\\/pharmacovigilance\\\/\",\"url\":\"https:\\\/\\\/www.dopharma.com\\\/en\\\/service-support\\\/pharmacovigilance\\\/\",\"name\":\"Pharmacovigilance - Dopharma\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.dopharma.com\\\/#website\"},\"datePublished\":\"2024-12-05T11:31:21+00:00\",\"dateModified\":\"2025-04-25T13:43:04+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.dopharma.com\\\/en\\\/service-support\\\/pharmacovigilance\\\/#breadcrumb\"},\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.dopharma.com\\\/en\\\/service-support\\\/pharmacovigilance\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.dopharma.com\\\/en\\\/service-support\\\/pharmacovigilance\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.dopharma.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Service &#038; 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