Norgine receives positive CHMP opinion recommending approval of NPJ5008 (dantrolene sodium hemiheptahydrate) for the treatment of malignant hyperthermia

Norgine, Amsterdam, The Netherlands, Tuesday 26 March. Norgine B.V. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of NPJ5008 (dantrolene sodium hemiheptahydrate) for the treatment of malignant hyperthermia. The European Commission (EC) will now review the CHMP’s recommendation. If approved, the centralized marketing authorization would be valid in all 27 EU member states, as well as in Iceland, Liechtenstein, and Norway and would be the first new treatment in Europe for malignant hyperthermia in over forty years. Submissions to the UK MHRA and Swiss Medic are ongoing. Dr David Gillen, Chief Medical Officer of Norgine, added: “We are delighted to have received a positive CHMP opinion for NPJ5008. Malignant hyperthermia (MH) is thankfully a rare medical emergency following anaesthesia. Nevertheless, it is clear that effective management of MH is critically important to improve clinical outcomes. NPJ5008 will allow faster administration compared to the existing dantrolene formulation and therefore, we believe, better outcomes for all European patients with MH.” ENDS For further information please contact: [email protected] www.norgine.com Follow us @norgine Notes to Editors: About Malignant Hyperthermia Malignant hyperthermia (MH) is a rare life-threatening pharmacogenetic disorder of skeletal muscles that presents as an exaggerated hypermetabolic response to volatile anaesthetic agents and depolarizing muscle relaxants.1 About NPJ5008 NPJ5008 is a novel formulation of dantrolene that has been developed by Norgine to shorten preparation and administration times versus DANTRIUM IV (dantrolene sodium). Each vial of NPJ5008 contains 120mg of dantrolene and is reconstituted in 20 mL of water for injections for intravenous administration.2 About Norgine Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. Our commitment to transforming people’s lives drives everything we do and our European experience, fully integrated infrastructure and exceptional partnership approach enable us to quickly apply creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access. Norgine is proud to have helped more than 25 million patients around the world in 2022 and generated €530 million in net product sales, a growth of nearly 5% over 2021. Norgine has a direct presence in 16 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing infrastructure. This enables us to acquire, develop and commercialise specialist and innovative products that make a real difference to the lives of patients around the world. NORGINE and the sail logo are trademarks of the Norgine group of companies. References Kaur et al. Mo Med. 2019;116(2):154–159 Ng Kwet Shing RH, et al. Eur J Anaesthesiol. 2024;41:1–10 Terms of Use Privacy Policy Information Security Cookie Policy Legal Entities www.norgine.com © Norgine 2020 All product names mentioned in this website are trademarks owned by or licensed to the Norgine group of companies, unless otherwise noted. {"prefetch":[{"source":"document","where":{"and":[{"href_matches":"/*"},{"not":{"href_matches":["/wp-*.php","/wp-admin/*","/wp-content/uploads/*","/wp-content/*","/wp-content/plugins/*","/wp-content/themes/base-theme/*","/*\\?(.+)"]}},{"not":{"selector_matches":"a[rel~=\"nofollow\"]"}},{"not":{"selector_matches":".no-prefetch, .no-prefetch a"}}]},"eagerness":"conservative"}]} function setCookie(name, value, days) { var expires = ""; if (days) { var date = new Date(); date.setTime(date.getTime() + (days * 24 * 60 * 60 * 1000)); expires = "; expires=" + date.toUTCString(); } document.cookie = name + "=" + (value || "") + expires + "; path=/"; } function getCookie(cname) { let name = cname + "="; let decodedCookie = decodeURIComponent(document.cookie); let ca = decodedCookie.split(';'); for (let i = 0; i < ca.length; i++) { let c = ca[i]; while (c.charAt(0) == ' ') { c = c.substring(1); } if (c.indexOf(name) == 0) { return c.substring(name.length, c.length); } } return ""; } function eraseCookie(name) { setCookie(name, "", -1); } document.addEventListener( 'wpcf7mailsent', function( event ) { var cf7rgk_json = getCookie("cf7rgk_options"); if(typeof cf7rgk_json != 'undefined') { var cf7rgk_opt = JSON.parse(decodeURIComponent(cf7rgk_json)); if (cf7rgk_opt != '') { if(cf7rgk_opt.url != '') { if (cf7rgk_opt.open_new == "on") { window.open(cf7rgk_opt.url, '_blank'); } else { window.open(cf7rgk_opt.url, '_self'); } } } eraseCookie("cf7rgk_options"); } }); We use cookies on this Website. You may find out more about these in “Preferences” or by reading our “Cookie Policy”. Close GDPR Cookie Banner Accept All Accept “Strictly Necessary Cookies” Only Preferences Close GDPR Cookie Banner wp.i18n.setLocaleData( { 'text direction\u0004ltr': [ 'ltr' ] } ); //# sourceURL=wp-i18n-js-after ( function( domain, translations ) { var localeData = translations.locale_data[ domain ] || translations.locale_data.messages; localeData[""].domain = domain; wp.i18n.setLocaleData( localeData, domain ); } )( "contact-form-7", {"translation-revision-date":"2026-05-05 18:32:38+0000","generator":"GlotPress\/4.0.3","domain":"messages","locale_data":{"messages":{"":{"domain":"messages","plural-forms":"nplurals=2; plural=n != 1;","lang":"en_GB"},"This contact form is placed in the wrong place.":["This contact form is placed in the wrong place."],"Error:":["Error:"]}},"comment":{"reference":"includes\/js\/index.js"}} ); //# sourceURL=contact-form-7-js-translations var wpcf7 = { "api": { "root": "https:\/\/norgine.com\/wp-json\/", "namespace": "contact-form-7\/v1" } }; //# sourceURL=contact-form-7-js-before var dnd_cf7_uploader = {"ajax_url":"https://norgine.com/wp-admin/admin-ajax.php","ajax_nonce":"17d0d456a3","drag_n_drop_upload":{"tag":"h3","text":"Drag &amp; Drop Files Here","or_separator":"or","browse":"Browse Files","server_max_error":"The uploaded file exceeds the maximum upload size of your server.","large_file":"Uploaded file is too large","inavalid_type":"Uploaded file is not allowed for file type","max_file_limit":"Note : Some of the files are not uploaded ( Only %count% files allowed )","required":"This field is required.","delete":{"text":"deleting","title":"Remove"}},"dnd_text_counter":"of","disable_btn":""}; //# sourceURL=codedropz-uploader-js-extra var wpcf7r = {"ajax_url":"https://norgine.com/wp-admin/admin-ajax.php"}; //# sourceURL=wpcf7-redirect-script-js-extra var uacf7_cf_object = {"10717":[{"uacf7_cf_hs":"hide","uacf7_cf_group":"","uacf7_cf_condition_for":"any","uacf7_cf_conditions":{"uacf7_cf_tn":["anony[]"],"uacf7_cf_operator":["equal"],"uacf7_cf_val":["I would like to remain anonymous"]}},{"uacf7_cf_hs":"show","uacf7_cf_group":"","uacf7_cf_condition_for":"any","uacf7_cf_conditions":{"uacf7_cf_tn":["relationship"],"uacf7_cf_operator":["equal"],"uacf7_cf_val":["Other (contractor, supplier, partner, prospective employee, etc)"]}}]}; //# sourceURL=uacf7-cf-script-js-extra var wpcf7cf_global_settings = {"ajaxurl":"https://norgine.com/wp-admin/admin-ajax.php"}; //# sourceURL=wpcf7cf-scripts-js-extra var moove_frontend_gdpr_scripts = {"ajaxurl":"https://norgine.com/wp-admin/admin-ajax.php","post_id":"11123","plugin_dir":"https://norgine.com/wp-content/plugins/gdpr-cookie-compliance","show_icons":"all","is_page":"","ajax_cookie_removal":"false","strict_init":"2","enabled_default":{"strict":1,"third_party":0,"advanced":0,"performance":0,"preference":0},"geo_location":"false","force_reload":"false","is_single":"1","hide_save_btn":"false","current_user":"0","cookie_expiration":"365","script_delay":"2000","close_btn_action":"1","close_btn_rdr":"","scripts_defined":"{\"cache\":false,\"header\":\"\",\"body\":\"\",\"footer\":\"\",\"thirdparty\":{\"header\":\"\",\"body\":\"\",\"footer\":\"\u003Cscript data-gdpr async src=\\\"https:\\/\\/platform.twitter.com\\/widgets.js\\\" charset=\\\"utf-8\\\"\u003E\u003C\\/script\u003E\"},\"strict\":{\"header\":\"\",\"body\":\"\",\"footer\":\"\"},\"advanced\":{\"header\":\"#\",\"body\":\"\",\"footer\":\"\u003C!-- Global site tag (gtag.js) - Google Analytics --\u003E\\r\\n\u003Cscript data-gdpr async src=\\\"https:\\/\\/www.googletagmanager.com\\/gtag\\/js?id=UA-49312391-1\\\"\u003E\u003C\\/script\u003E\\r\\n\u003Cscript data-gdpr\u003E\\r\\n window.dataLayer = window.dataLayer || [];\\r\\n function gtag(){dataLayer.push(arguments);}\\r\\n gtag('js', new Date());\\r\\n\\r\\n gtag('config', 'UA-49312391-1', { 'anonymize_ip': true });\\r\\n\u003C\\/script\u003E\\r\\n\\r\\n\u003Cscript data-gdpr\u003E\\r\\n\\/\\/ Set to the same value as the web property used on the site\\r\\nvar gaProperty = 'UA-49312391-1';\\r\\n\\r\\n\\/\\/ Disable tracking if the opt-out cookie exists.\\r\\nvar disableStr = 'ga-disable-' + gaProperty;\\r\\nif (document.cookie.indexOf(disableStr + '=true') \u003E -1) {\\r\\n window[disableStr] = true;\\r\\n}\\r\\n\\r\\n\\/\\/ Opt-out function\\r\\nfunction gaOptout() {\\r\\n\\tconsole.log(\\\"cookie \\\"+document.cookie);\\r\\n document.cookie = disableStr + '=true; expires=Thu, 31 Dec 2099 23:59:59 UTC; path=\\/';\\r\\n window[disableStr] = true;\\r\\n}\\r\\n\u003C\\/script\u003E\\r\\n\"},\"performance\":{\"header\":\"\",\"body\":\"\",\"footer\":\"\"},\"preference\":{\"header\":\"\",\"body\":\"\",\"footer\":\"\"}}","gdpr_scor":"true","wp_lang":"","wp_consent_api":"false","gdpr_nonce":"917a7fcda0","gdpr_consent_version":"1","gdpr_uvid":"dd2d59fe6e9a0b3c99d44119b15a69cd","stats_enabled":"","gdpr_aos_hide":"false","consent_log_enabled":"","enable_on_scroll":"false","ifbc":"advanced","ifbc_excl":"[\"google.com\\/recaptcha\",\"recaptcha.net\\/recaptcha\",\"gstatic.com\\/recaptcha\"]"}; //# sourceURL=moove_gdpr_frontend-js-extra var gdpr_c=document.cookie.match(/(?:^|;\s*)moove_gdpr_popup=([^;]*)/);var gdpr_d=gdpr_c?JSON.parse(decodeURIComponent(gdpr_c[1])):{};var gdpr_consent__strict=gdpr_d.strict==="1"?"true":"false";var gdpr_consent__thirdparty=gdpr_d.thirdparty==="1"?"true":"false";var gdpr_consent__advanced=gdpr_d.advanced==="1"?"true":"false";var gdpr_consent__performance=gdpr_d.performance==="1"?"true":"false";var gdpr_consent__preference=gdpr_d.preference==="1"?"true":"false";var _cc=[];if(gdpr_d.strict==="1")_cc.push("strict");if(gdpr_d.thirdparty==="1")_cc.push("thirdparty");if(gdpr_d.advanced==="1")_cc.push("advanced");if(gdpr_d.performance==="1")_cc.push("performance");if(gdpr_d.preference==="1")_cc.push("preference");var gdpr_consent__cookies=_cc.join("|"); //# sourceURL=moove_gdpr_frontend-js-after {"baseUrl":"https://s.w.org/images/core/emoji/17.0.2/72x72/","ext":".png","svgUrl":"https://s.w.org/images/core/emoji/17.0.2/svg/","svgExt":".svg","source":{"concatemoji":"https://norgine.com/wp-includes/js/wp-emoji-release.min.js?ver=c8e497026f1f2aea9c53a5108f0dabab"}} /*! This file is auto-generated */ var e="script#wp-emoji-settings",t=document.querySelector(e);if(!(t instanceof HTMLScriptElement))throw new Error("Element missing: "+e);const r=JSON.parse(t.text),s=(window._wpemojiSettings=r,"wpEmojiSettingsSupports"),o=["flag","emoji"];function i(e){try{var t={supportTests:e,timestamp:(new Date).valueOf()};sessionStorage.setItem(s,JSON.stringify(t))}catch(e){}}function c(e,t,n){e.clearRect(0,0,e.canvas.width,e.canvas.height),e.fillText(t,0,0);t=new Uint32Array(e.getImageData(0,0,e.canvas.width,e.canvas.height).data);e.clearRect(0,0,e.canvas.width,e.canvas.height),e.fillText(n,0,0);const r=new Uint32Array(e.getImageData(0,0,e.canvas.width,e.canvas.height).data);return t.every((e,t)=>e===r[t])}function p(e,t){e.clearRect(0,0,e.canvas.width,e.canvas.height),e.fillText(t,0,0);var n=e.getImageData(16,16,1,1);for(let e=0;e<n.data.length;e++)if(0!==n.data[e])return!1;return!0}function u(e,t,n,r){switch(t){case"flag":return n(e,"\ud83c\udff3\ufe0f\u200d\u26a7\ufe0f","\ud83c\udff3\ufe0f\u200b\u26a7\ufe0f")?!1:!n(e,"\ud83c\udde8\ud83c\uddf6","\ud83c\udde8\u200b\ud83c\uddf6")&&!n(e,"\ud83c\udff4\udb40\udc67\udb40\udc62\udb40\udc65\udb40\udc6e\udb40\udc67\udb40\udc7f","\ud83c\udff4\u200b\udb40\udc67\u200b\udb40\udc62\u200b\udb40\udc65\u200b\udb40\udc6e\u200b\udb40\udc67\u200b\udb40\udc7f");case"emoji":return!r(e,"\ud83e\u1fac8")}return!1}function f(e,t,n,r){let a;const s=(a="undefined"!=typeof WorkerGlobalScope&&self instanceof WorkerGlobalScope?new OffscreenCanvas(300,150):document.createElement("canvas")).getContext("2d",{willReadFrequently:!0}),o=(s.textBaseline="top",s.font="600 32px Arial",{});return e.forEach(e=>{o[e]=t(s,e,n,r)}),o}function a(e){var t=document.createElement("script");t.src=e,t.defer=!0,document.head.appendChild(t)}r.supports={everything:!0,everythingExceptFlag:!0},new Promise(t=>{let n=function(){try{var e=JSON.parse(sessionStorage.getItem(s));if("object"==typeof e&&"number"==typeof e.timestamp&&(new Date).valueOf()<e.timestamp+604800&&"object"==typeof e.supportTests)return e.supportTests}catch(e){}return null}();if(!n){if("undefined"!=typeof Worker&&"undefined"!=typeof OffscreenCanvas&&"undefined"!=typeof URL&&URL.createObjectURL&&"undefined"!=typeof Blob)try{var e="postMessage("+f.toString()+"("+[JSON.stringify(o),u.toString(),c.toString(),p.toString()].join(",")+"));",r=new Blob([e],{type:"text/javascript"});const a=new Worker(URL.createObjectURL(r),{name:"wpTestEmojiSupports"});return void(a.onmessage=e=>{i(n=e.data),a.terminate(),t(n)})}catch(e){}i(n=f(o,u,c,p))}t(n)}).then(e=>{for(const n in e)r.supports[n]=e[n],r.supports.everything=r.supports.everything&&r.supports[n],"flag"!==n&&(r.supports.everythingExceptFlag=r.supports.everythingExceptFlag&&r.supports[n]);var t;r.supports.everythingExceptFlag=r.supports.everythingExceptFlag&&!r.supports.flag,r.supports.everything||((t=r.source||{}).concatemoji?a(t.concatemoji):t.wpemoji&&t.twemoji&&(a(t.twemoji),a(t.wpemoji)))}); //# sourceURL=https://norgine.com/wp-includes/js/wp-emoji-loader.min.js Change cookie settings Close GDPR Cookie Settings Cookie Policy Strictly Necessary Cookies Functional Cookies Performance Cookies Cookie Policy Last update: 1 August 2023 What are cookies? Cookies are small data files that websites download to a user’s computer, phone or tablet. Most web browsers automatically accept cookies. They help website providers, for example, to recognise a user that has visited a website previously. Further details on the cookies used on this Website and their purposes are set out below. Helping you navigate the Website in the most easy way possible Assisting in registering for our events, login and your ability to provide feedback Analysing site usage (how many users visited a specific page for example) Analysing the use of our products, services or applications Assisting with our promotional and marketing efforts (including behavioural advertising) Offering content of third parties (such as social media content) Detailed information about each cookie can be found in the appropriate cookie category section of the banner as well as in the section below. Cookie Category Description STRICTLY NECESSARY COOKIES The strictly necessary cookies help make a website usable by enabling basic functions like page navigation and access to secure areas of the website. These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You may be able to decline these cookies through your browser, but necessary parts of the site will not then work. These cookies do not store any personally identifiable information. Detailed list of Strictly Necessary Cookies First- and Third-party Cookies Name Provider Purpose Retention Third Party moove_gdpr_popup mooveagency.com Records cookie settings. For user preferences only. No external interaction 1 year FUNCTIONAL COOKIES These cookies enable the website to provide enhanced functionality and personalization. They may be set by us or by third-party providers whose services we have added to our pages. If you do not allow these cookies then some or all of these services may not function properly. Detailed list of Functional Cookies First- and Third-party Cookies Name Provider Purpose Retention Third Party Various Youtube User preferences, consent, location and marketing 2 to 400 days PERFORMANCE COOKIES These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. Detailed list of Performance Cookies First- and Third-party Cookies Name Provider Purpose Retention Third Party _ga_ google.com Record visitors cookie choice. 400 days Third Party _gat_gtag_ google.com Records tracking code data 1 minute Third Party _ga google.com Calculates visitor, session and campaign data and also keeps track of site usage. 400 days Third Party _gid google.com Registers a unique ID that is used to generate statistical data on how the visitor uses the website. 1 day MARKETING COOKIES These cookies are used to track our visitors’ browsing habits. They can be used to build up a profile of search and/or browsing history for every visitor. Identifiable or unique data is collected to show relevant/personalized marketing content to each user. The information that uniquely identifies users’ browsers and internet devices is used to display targeted advertising and/or share this data with third parties for the same purpose. Detailed list of Marketing Cookies First- and Third-party Cookies Name Provider Purpose Retention Not applicable Refusing cookies You do not have to accept cookies, but without accepting them you may experience reduced Site functionality. You can manage your preferences regarding cookies and other tracking technologies and revoke your consent in the banner. You can withdraw your consent at any time. If you would like more information about deleting, disabling and blocking cookies, please visit the website: https://knowcookies.com and check the “manage cookies” and “webmasters guide” sections. Updating our Cookie Policy There is a possibility that we will update our cookie policy on this website in accordance with legal and technical requirements, therefore we recommend that you read this policy occasionally so that you are adequately informed about how and for what we use cookies. Contact If you have any questions about this Cookie Policy or the collection, processing and disclosure of your personal data and your data protection rights, please see our Privacy Policy. Strictly Necessary Cookies Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings. Enable or Disable Cookies Enabled Disabled Functional Cookies You need to enable YouTube cookies to display video content on this website. Enable or Disable Cookies Enabled Disabled Performance Cookies This website uses Google Analytics to collect anonymous information such as the number of visitors to the site, and the most popular pages. Enable or Disable Cookies Enabled Disabled Enable All Save Changes (function($) { $('ul.nav li.dropdown').hover(function() { $(this).children('.dropdown-menu').stop(true, true).delay(200).fadeIn(500); }, function() { $(this).children('.dropdown-menu').stop(true, true).delay(200).fadeOut(500); }); })( jQuery ); (function($) { $('body').on('click', '.class_warning_3', function (e) { event.preventDefault(); href = $(this).attr('href'); target = $(this).attr('target'); confirm('Warning', 'You are being directed to our global job application website, please click OK if you want to proceed or Cancel if you wish to remain on www.norgine.com.', 'OK', 'Cancel', href, target); });$('body').on('click', '.mega-class_warning_3', function (e) { event.preventDefault(); href = $(this).children().attr('href'); target = $(this).children().attr('target'); confirm('Warning', 'You are being directed to our global job application website, please click OK if you want to proceed or Cancel if you wish to remain on www.norgine.com.', 'OK', 'Cancel', href, target); });$('body').on('click', '.class_warning_1', function (e) { event.preventDefault(); href = $(this).attr('href'); target = $(this).attr('target'); confirm('Warning', 'You are about to leave www.norgine.com, please click OK if you want to proceed or Cancel if you wish to remain on www.norgine.com', 'OK', 'Cancel', href, target); });$('body').on('click', '.mega-class_warning_1', function (e) { event.preventDefault(); href = $(this).children().attr('href'); target = $(this).children().attr('target'); confirm('Warning', 'You are about to leave www.norgine.com, please click OK if you want to proceed or Cancel if you wish to remain on www.norgine.com', 'OK', 'Cancel', href, target); });$('body').on('click', '.class_warning_2', function (e) { event.preventDefault(); href = $(this).attr('href'); target = $(this).attr('target'); confirm('Confirm', 'You are about to access Norgine historic archive material. Any reference in these archives to Norgine products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data or safety data. Please refer to your approved national product label (SmPC) for current product information.<br /> <br /> I have read this warning and will not be using any of the contained product information for clinical purposes.', 'I agree', 'I disagree', href, target); });$('body').on('click', '.mega-class_warning_2', function (e) { event.preventDefault(); href = $(this).children().attr('href'); target = $(this).children().attr('target'); confirm('Confirm', 'You are about to access Norgine historic archive material. Any reference in these archives to Norgine products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data or safety data. Please refer to your approved national product label (SmPC) for current product information.<br /> <br /> I have read this warning and will not be using any of the contained product information for clinical purposes.', 'I agree', 'I disagree', href, target); }); })( jQuery ); function confirm(title, message, button1, button2, href, target) { event.preventDefault(); $.confirm({ title: title, content: message, bgOpacity: 0.8, buttons: { button1: { text: button1, action: function () { if (target=='_blank') { window.open(href); } else { location.href = href; } } }, button2: { text: button2, action: function () { return true; } } } }); } function signup_confirm(message, button1) { event.preventDefault(); $.confirm({ title: ' ', content: message, buttons: { button1: { text: button1 } } }); } function confirm_archive(title, message, button1, button2, href, default_href) { $.confirm({ title: title, content: message, bgOpacity: 0.8, buttons: { button1: { text: button1, action: function () { document.cookie = 'media_archive=clicked; path=/'; location.href = href; } }, button2: { text: button2, action: function () { location.href = default_href; return true; } } } }); }

The release as fetched from its publisher. norgine.com ↗