{"id":7481,"date":"2022-11-08T12:40:42","date_gmt":"2022-11-08T12:40:42","guid":{"rendered":"https:\/\/cinmed.me\/farmakovigilanca\/lista-ljekova-pod-dodatnim-pracenjem\/"},"modified":"2026-03-02T10:27:47","modified_gmt":"2026-03-02T09:27:47","slug":"list-of-medicines-under-additional-monitoring","status":"publish","type":"page","link":"https:\/\/cinmed.me\/en\/pharmacovigilance\/list-of-medicines-under-additional-monitoring\/","title":{"rendered":"List of medicines under additional monitoring"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7481\" class=\"elementor elementor-7481 elementor-645\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b1cc3b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b1cc3b4\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-wider\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-b11a068\" data-id=\"b11a068\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-dc3d9b1 elementor-widget elementor-widget-image\" data-id=\"dc3d9b1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/rezerva-1024x576.jpg\" class=\"attachment-large size-large wp-image-8421\" alt=\"Lista ljekova pod dodatnim pracenjem\" srcset=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/rezerva-1024x576.jpg 1024w, https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/rezerva-300x169.jpg 300w, https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/rezerva-768x432.jpg 768w, https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/rezerva.jpg 1100w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb5dca3 elementor-widget elementor-widget-text-editor\" data-id=\"cb5dca3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>In accordance with the <a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/02\/Law-on-medicinal-products_-eng.pdf\" target=\"_blank\" rel=\"noopener\">Law on Medicinal Products<\/a> , the Institute for Medicines and Medical Devices (CInMED) publishes the List of medicinal products under additional monitoring, formed by the European Medicines Agency (EMA). Medicines whose safety is additionally monitored are labelled by a black inverted triangle. This medicinal product is under additional monitoring. This label is accompanied by the explanation in the <a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/03\/Obrazac_za_SmPC_0902023-7.docx\" target=\"_blank\" rel=\"noopener\">Summary of product characteristics <\/a>and <a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/03\/Obrazac_za_PIL_09022023-8.docx\" target=\"_blank\" rel=\"noopener\">Package Leaflet<\/a>.<\/p><p>Label that the medicinal products is under additional monitoring does not mean that the medicinal product is not safe to use, but that it is of special importance that healthcare professionals and patients report any suspected adverse reactions to these medicines, in order to speed up the collection of information on their safe use.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2bb6663 elementor-widget elementor-widget-text-editor\" data-id=\"2bb6663\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>In accordance with EU regulations, medicinal products from the EMA List of medicinal products under additional monitoring are listed as follows:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d51d237 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"d51d237\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>medicinal products that contain a new active substance authorised in the EU after 1 January 2011;<\/li><li>biological medicinal products authorised after 1 January 2011 &#8211; this applies to all biological medicinal products including biosimilars;<\/li><li>medicinal products for which the marketing authorisation holder is required to carry out a post-authorisation safety study (PASS);<\/li><li>medicinal products given conditional approval, or authorised under exceptional circumstances and medicines authorised with specific obligations on the monitoring and reporting of suspected adverse reactions to medicinal products.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a3b4b1b elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"a3b4b1b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>medicinal products that contain a new active substance authorised in the EU after 1 January 2011;<\/li><li>biological medicinal products authorised after 1 January 2011 &#8211; this applies to all biological medicinal products including biosimilars;<\/li><li>medicinal products for which the marketing authorisation holder is required to carry out a post-authorisation safety study (PASS);<\/li><li>medicinal products given conditional approval, or authorised under exceptional circumstances and medicines authorised with specific obligations on the monitoring and reporting of suspected adverse reactions to medicinal products.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2af8668 elementor-widget elementor-widget-text-editor\" data-id=\"2af8668\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>\u00a0<\/p><p><strong>The list of medicinal products under additional monitoring<\/strong> is updated once a month by EMA and is available <a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/post-authorisation\/pharmacovigilance\/medicines-under-additional-monitoring\/list-medicines-under-additional-monitoring\" target=\"_blank\" rel=\"noopener\">here<\/a>. CInMED may order additional monitoring for medicinal products that are authorised in Montenegro and are not on the EMA List.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-6efbd9f\" data-id=\"6efbd9f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-8a834cb elementor-widget elementor-widget-shortcode\" data-id=\"8a834cb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t    <div class=\"sidebar-menu-wrapper\">\r\n        <div class=\"sidebar-menu-header\">\r\n            <img decoding=\"async\" class=\"sidebar-menu-header-icon\" src=\"\/wp-content\/uploads\/2022\/11\/4.png\" \/>\r\n            <P><a class=\"sidebar-menu-header-title\" href=\"\">Pharmacovigilance<\/a><\/P>\r\n        <\/div>\r\n        <div class=\"sidebar-items-background\">\r\n            <div class=\"sidebar-items-wrapper\">\r\n                <div class=\"menu-farmakovigilanca-container\"><ul id=\"menu-farmakovigilanca\" class=\"list-none\t\"><li id=\"menu-item-7342\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7342 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/osnovni-pojmovi\/\">General information<\/a><\/li>\n<li id=\"menu-item-7343\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7343 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/prijava-nezeljenog-dejstva-lijeka\/\">Adverse reactions to medicines reporting<\/a><\/li>\n<li id=\"menu-item-7344\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7344 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/uputstva-za-nosioca-dozvole-za-lijek\/\">Instructions for marketing authorisation holders<\/a><\/li>\n<li id=\"menu-item-7345\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7345 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/pisma-zdravstvenim-radnicima\/\">Direct Healthcare Professional Communication<\/a><\/li>\n<li id=\"menu-item-7346\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7346 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/mjere-minimizacije-rizika\/\">Risk minimisation measures<\/a><\/li>\n<li id=\"menu-item-7348\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7348 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/lista-ozbiljnih-nezeljenih-dejstava\/\">List of serious adverse reactions<\/a><\/li>\n<li id=\"menu-item-7349\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7349 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/lista-ljekova-pod-dodatnim-pracenjem\/\">List of medicines under additional monitoring<\/a><\/li>\n<li id=\"menu-item-7350\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7350 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/godisnji-izvjestaji\/\">Annual reports<\/a><\/li>\n<\/ul><\/div>            <\/div>\r\n        <\/div>\r\n    <\/div>\r\n\t\t<div class=\"elementor-shortcode\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7563f3a elementor-widget elementor-widget-shortcode\" data-id=\"7563f3a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"relative pt-10 rounded bg-primary pb-72\">\n\t<h1 class=\"ml-10 text-4xl text-white \">Search <span class=\"font-bold\">register<\/span><\/h1>\n\t<div class=\"mt-8 \">\n\t\t<h3 class=\"mb-4 ml-10 text-secondary text-medium \">Here you can search for medicines in our register<\/h3>\n\t\t<div class=\"relative inline-block w-4\/5 ml-10 text-left\" style=\"width:80%\">\n\t\t\t<div>\n\t\t\t\t<select onchange=\"javascript:handleSelect(this)\" class=\"block h-[52px] text-[18px] text-light appearance-none w-full bg-white py-3 px-4 pr-8 rounded leading-tight focus:outline-none focus:bg-white focus:border-none\">\n\t\t\t\t\t<option class=\"text-[18px]\" value=\"\">Choose register<\/option>\n\t\t\t\t\t<option class=\"text-[18px]\" value=\"\/en\/register-of-medicines-for-human-use\/\">Register of medicines for human use<\/option>\n\t\t\t\t\t<option class=\"text-[18px]\" value=\"\/en\/register-of-veterinary-medicines\/\">Register of veterinary medicines<\/option>\n\t\t\t\t\t<option class=\"text-[18px]\" value=\"\/en\/medical-devices\/register-of-medical-devices\/\">Register of medical devices<\/option>\n\t\t\t\t<\/select>\n\n\t\t\t\t<script type=\"text\/javascript\">\n\t\t\t\t\tfunction handleSelect(elm) {\n\t\t\t\t\t\twindow.location = elm.value;\n\t\t\t\t\t}\n\t\t\t\t<\/script>\n\t\t\t\t<img decoding=\"async\" style=\"top:22px;\" class=\"absolute right-[15px] top-[22px] \" 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       <\/p>\n      <\/div>\n    <\/form>\n\n      <\/div>\n\n  \t<\/div>\n\t<img decoding=\"async\" class=\"absolute bottom-0 left-0 w-[380px] \" src=\"\/wp-content\/uploads\/2022\/11\/newsletter.png\" \/>\n<\/div>\t\t<div class=\"elementor-shortcode\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>In accordance with the Law on Medicinal Products , the Institute for Medicines and Medical Devices (CInMED) publishes the List of medicinal products under additional monitoring, formed by the European Medicines Agency (EMA). Medicines whose safety is additionally monitored are labelled by a black inverted triangle. This medicinal product is under additional monitoring. This label [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":7479,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"cinmed-template-custom.php","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-7481","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>List of medicines under additional monitoring - Cinmed<\/title>\n<meta name=\"description\" content=\"List of medicines under additional monitoring Summary of product characteristics and Package Leaflet.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cinmed.me\/en\/pharmacovigilance\/list-of-medicines-under-additional-monitoring\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"List of medicines under additional monitoring - 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