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<title>Nintedanib Accord | European Medicines Agency (EMA)</title><link rel="stylesheet" media="all" href="/sites/default/files/css/css_lImSWMU9xNo_aga5rIlJttWMNj6B-aFRx_swfGzRfTI.css?delta=0&language=en&theme=ema_theme&include=eJxtj1GOwzAIRC_kxl89j4WdaWIFG8uQZnv7dbOtth8VEtI80MCgUEgb5mzSrx6FLjPZqMhQpw81FB9J4QThWLOBKYK92oNPFkVMrVMLtqLAx8Tf8N_-sH_p56GTqcOPca6bn_veiKeXPE0obcGkvUcf6FIo19Ovk-W6-JtUowMqBZ94QUUndveMQ_3ZpyLzPp4pIzT5W2ZDnxI1y1Jdo07LeHvV99F_Mu217ZGzrpidgnpaA7UcaDdJUhrDRtDv_BdS7Iyd" /> <link rel="stylesheet" media="all" href="/sites/default/files/css/css_YrQCHRRF3S2jeKHqnGxiu3VAkAyyZT6746sb2rkXgKI.css?delta=1&language=en&theme=ema_theme&include=eJxtj1GOwzAIRC_kxl89j4WdaWIFG8uQZnv7dbOtth8VEtI80MCgUEgb5mzSrx6FLjPZqMhQpw81FB9J4QThWLOBKYK92oNPFkVMrVMLtqLAx8Tf8N_-sH_p56GTqcOPca6bn_veiKeXPE0obcGkvUcf6FIo19Ovk-W6-JtUowMqBZ94QUUndveMQ_3ZpyLzPp4pIzT5W2ZDnxI1y1Jdo07LeHvV99F_Mu217ZGzrpidgnpaA7UcaDdJUhrDRtDv_BdS7Iyd" /> </head><body id="oe-back-to-top" class="context-ema_content_banner 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class="row"><div class="right-col"><div class="card-body container"><div class="row"><div class="col"><div class="heading-title"><h1 class="content-banner-title card-title bcl-heading"><span>Nintedanib Accord</span></h1></div><div class="heading-actions align-self-stretch d-flex justify-content-end"><div class="action-bar"><a href="/en/individual-human-medicine.xml/232653" target="_blank" title="RSS feed for Nintedanib Accord" class="btn btn-outline-primary ema-rss-button"><span class="rss-icon"></span> RSS</a><div class="ema-social-media-share button"><script type="application/json">{"service":"share","version":"2.0","more":["email","linkedin","x","facebook","whatsapp","blogger","digg","gmail","netvibes","pinterest","pocket","printfriendly","qzone","reddit","threads","tumblr","typepad","viadeo","weibo","yahoomail","yammer"],"selection":true,"stats":true,"target":"_blank"}</script></div></div></div><div class="heading-status"><div data-medicine-status="authorised" data-medicine-icon="check-circle-fill" data-medicine-color="status-success" class="medicine-status"><h5 class="status-title">Authorised</h5><div class="status-message"><p>This medicine is authorised for use in the European Union</p></div></div></div><div class="card-content-block"><div class="card-content-wrapper"><div class="content"><span class="fst-italic">nintedanib</span></div></div><div class="d-flex flex-column flex-lg-row justify-content-between gap-3"><div class="card-badge-wrapper d-flex flex-row flex-wrap gap-3 align-items-start"><span class="bundle-name badge rounded-pill bg-primary" title="Medicine"><span class="label">Medicine</span></span><span class="ema-bg-category badge rounded-pill badge-outline-primary" title="Human"><span class="label">Human</span></span><span class="ema-bg-medicine-status badge rounded-pill bg-success" title="Authorised"><span class="label">Authorised</span></span></div></div></div></div></div></div></div></div></article></div></div></div></div></div></div><div class="col-12 "><div class="row"><div class="col-12"><div id="block-system-main-block" class="main-content"><article class="content-with-sidebar node ema-medicine ema-medicine--full container"><div class="row"><div class="bcl-sidebar col-md-3"><nav class="bcl-inpage-navigation position-sticky" id="bcl-inpage-navigation"><h2 class="mb-0 dropdown-toggle bcl-heading" aria-expanded="false" type="button" id="bcl-inpage-navigation-dropdown" data-bs-toggle="dropdown"> Page contents<svg class="bi icon--s" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#chevron-down"/></svg></h2><div class="dropdown-menu" role="navigation" aria-labelledby="bcl-inpage-navigation-dropdown"><ul class="nav nav-pills flex-column" ><li class="nav-item" ><a class="nav-link" href="#overview">Overview</a></li><li class="nav-item" ><a class="nav-link" href="#product-info">Product information</a></li><li class="nav-item" ><a class="nav-link" href="#product-details">Product details</a></li><li class="nav-item" ><a class="nav-link" href="#authorisation-details">Authorisation details</a></li><li class="nav-item" ><a class="nav-link" href="#assessment-history">Assessment history</a></li><li class="nav-item" ><a class="nav-link" href="#news-on">News on Nintedanib Accord</a></li></ul></div></nav></div><div class="col-md-9"><div class="ema-node-content-wrapper node-sections"><div class="ema-statuses-timeline"><ul class="timeline"><li class="status checked first">Application under evaluation</li><li class="status checked">CHMP opinion</li><li class="status current last">European Commission decision</li></ul></div><div id="ema-inpage-item-overview" data-section="overview" class="section overview main-section"><h2 id="overview" class="h2 rounded-title">Overview</h2><p>Nintedanib Accord is a medicine used to treat adults with:</p><ul><li>idiopathic pulmonary fibrosis (IPF), a disease of unknown cause in which fibrous tissue forms in the lungs;</li><li>systemic sclerosis associated interstitial lung disease, a disease in which the immune system (the body’s natural defences) is overactive, causing production of fibrous tissue and progressive scarring of the lungs;</li><li>other chronic fibrosing interstitial lung diseases which are progressive.</li></ul><p>Nintedanib Accord contains the active substance nintedanib and is a ‘generic medicine’. This means that Nintedanib Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Nintedanib Accord is Ofev. For more information on generic medicines, see the question-and-answer document <a href="https://www.ema.europa.eu/en/documents/other/questions-and-answers-generic-medicines_en.pdf">here</a>.</p><div class="mt-3"><div class="accordion" id="accordion-bcl-accordion"><div class="accordion-items-wrapper"><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion-1"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion-1" aria-controls="collapse-bcl-accordion-1" aria-expanded="false" type="button" ><span>How is Nintedanib Accord used?</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion-1" aria-labelledby="heading-bcl-accordion-1" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><p>Nintedanib Accord can only be obtained with a prescription and treatment should be started by a doctor experienced in the diagnosis and treatment of the diseases it is used for.</p><p>It is available as capsules to be taken twice a day with food, approximately 12 hours apart.</p><p>For more information about using Nintedanib Accord, see the package leaflet or contact your doctor or pharmacist.</p></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion-2"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion-2" aria-controls="collapse-bcl-accordion-2" aria-expanded="false" type="button" ><span>How does Nintedanib Accord work?</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion-2" aria-labelledby="heading-bcl-accordion-2" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><p>The active substance in Nintedanib Accord, nintedanib, blocks the activity of some enzymes known as tyrosine kinases. These enzymes are present in certain receptors (such as VEGF, FGF and PDGF receptors) in cells in the lungs, where they activate several processes involved in the generation of fibrous tissue. By blocking these enzymes, nintedanib helps to reduce the formation of fibrous tissue in the lungs, thereby helping to prevent the symptoms of the disease from getting worse.</p></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion-3"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion-3" aria-controls="collapse-bcl-accordion-3" aria-expanded="false" type="button" ><span>How has Nintedanib Accord been studied?</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion-3" aria-labelledby="heading-bcl-accordion-3" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><p>Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Ofev, and do not need to be repeated for Nintedanib Accord. </p><p>As for every medicine, the company provided studies on the quality of Nintedanib Accord. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.</p></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion-4"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion-4" aria-controls="collapse-bcl-accordion-4" aria-expanded="false" type="button" ><span>What are the benefits and risks of Nintedanib Accord?</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion-4" aria-labelledby="heading-bcl-accordion-4" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><p>Because Nintedanib Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.</p></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion-5"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion-5" aria-controls="collapse-bcl-accordion-5" aria-expanded="false" type="button" ><span>Why is Nintedanib Accord authorised in the EU?</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion-5" aria-labelledby="heading-bcl-accordion-5" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><p>The European Medicines Agency concluded that, in accordance with EU requirements, Nintedanib Accord has been shown to have comparable quality and to be bioequivalent to Ofev. Therefore, the Agency’s view was that, as for Ofev, the benefits of Nintedanib Accord outweigh the identified risks and it can be authorised for use in the EU.</p></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion-6"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion-6" aria-controls="collapse-bcl-accordion-6" aria-expanded="false" type="button" ><span>What measures are being taken to ensure the safe and effective use of Nintedanib Accord?</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion-6" aria-labelledby="heading-bcl-accordion-6" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><p>Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nintedanib Accord have been included in the summary of product characteristics and the package leaflet. </p><p>Any additional measures in place for Ofev also apply to Nintedanib Accord where appropriate. </p><p>As for all medicines, data on the use of Nintedanib Accord are continuously monitored. Suspected side effects reported with Nintedanib Accord are carefully evaluated and any necessary action taken to protect patients.</p></div></div></div></div><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion-7"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion-7" aria-controls="collapse-bcl-accordion-7" aria-expanded="false" type="button" ><span>Other information about Nintedanib Accord</span></button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion-7" aria-labelledby="heading-bcl-accordion-7" role="region"><div class="accordion-body"><div class="ema-faq__body ecl-editor"><p>Nintedanib Accord received a marketing authorisation valid throughout the EU on 19 April 2024.</p></div></div></div></div></div></div></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="overview" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Nintedanib Accord : EPAR - Medicine overview</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/95127/2024</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (182.87 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2024-04-22T10:27:06Z">22/04/2024</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/overview/nintedanib-accord-epar-medicine-overview_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div><div class="file-translations bg-lighter py-3 px-3-5 border-top"><div class="text-center"><a class="standalone" aria-controls="file-language-dropdown-964" data-bs-toggle="collapse" aria-expanded="false" role="button" href="#file-language-dropdown-964">Other languages (22)<svg class="ms-2-5 bi icon--2xs" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#caret-down-fill"/></svg></a></div><div class="collapse" id="file-language-dropdown-964"><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> български (BG) <span class="fw-normal"> (206.82 KB - 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PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/pt/documents/overview/nintedanib-accord-epar-medicine-overview_pt.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> română (RO) <span class="fw-normal"> (202.32 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/ro/documents/overview/nintedanib-accord-epar-medicine-overview_ro.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> slovenčina (SK) <span class="fw-normal"> (204.18 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/sk/documents/overview/nintedanib-accord-epar-medicine-overview_sk.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> slovenščina (SL) <span class="fw-normal"> (201.61 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/sl/documents/overview/nintedanib-accord-epar-medicine-overview_sl.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> Suomi (FI) <span class="fw-normal"> (181.09 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/fi/documents/overview/nintedanib-accord-epar-medicine-overview_fi.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="pt-3"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> svenska (SV) <span class="fw-normal"> (181.86 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/sv/documents/overview/nintedanib-accord-epar-medicine-overview_sv.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div></div></div></div></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="rmp" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Nintedanib Accord : EPAR - Risk management plan</p></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (487.72 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2024-04-22T10:30:28Z">22/04/2024</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2024-06-20T14:30:00Z">20/06/2024</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/rmp/nintedanib-accord-epar-risk-management-plan_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div></div></div><div id="ema-inpage-item-product-info" data-section="product-info" class="section product-info main-section"><h2 id="product-info" class="h2 rounded-title">Product information</h2><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="product-information" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Nintedanib Accord : EPAR - Product information</p></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (681.14 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2024-04-22T10:32:03Z">22/04/2024</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/product-information/nintedanib-accord-epar-product-information_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div><div class="file-translations bg-lighter py-3 px-3-5 border-top"><div class="text-center"><a class="standalone" aria-controls="file-language-dropdown-961" data-bs-toggle="collapse" aria-expanded="false" role="button" href="#file-language-dropdown-961">Other languages (24)<svg class="ms-2-5 bi icon--2xs" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#caret-down-fill"/></svg></a></div><div class="collapse" id="file-language-dropdown-961"><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> български (BG) <span class="fw-normal"> (1.04 MB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/bg/documents/product-information/nintedanib-accord-epar-product-information_bg.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> español (ES) <span class="fw-normal"> (946.2 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/es/documents/product-information/nintedanib-accord-epar-product-information_es.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> čeština (CS) <span class="fw-normal"> (795.67 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/cs/documents/product-information/nintedanib-accord-epar-product-information_cs.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> dansk (DA) <span class="fw-normal"> (940.81 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/da/documents/product-information/nintedanib-accord-epar-product-information_da.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> Deutsch (DE) <span class="fw-normal"> (882.86 KB - 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PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/el/documents/product-information/nintedanib-accord-epar-product-information_el.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> français (FR) <span class="fw-normal"> (789.57 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/fr/documents/product-information/nintedanib-accord-epar-product-information_fr.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> hrvatski (HR) <span class="fw-normal"> (1.25 MB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/hr/documents/product-information/nintedanib-accord-epar-product-information_hr.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> íslenska (IS) <span class="fw-normal"> (1.51 MB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/is/documents/product-information/nintedanib-accord-epar-product-information_is.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> italiano (IT) <span class="fw-normal"> (752.17 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/it/documents/product-information/nintedanib-accord-epar-product-information_it.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> latviešu valoda (LV) <span class="fw-normal"> (855.03 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/lv/documents/product-information/nintedanib-accord-epar-product-information_lv.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> lietuvių kalba (LT) <span class="fw-normal"> (857.54 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/lt/documents/product-information/nintedanib-accord-epar-product-information_lt.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> magyar (HU) <span class="fw-normal"> (1.17 MB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/hu/documents/product-information/nintedanib-accord-epar-product-information_hu.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> Malti (MT) <span class="fw-normal"> (839.88 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/mt/documents/product-information/nintedanib-accord-epar-product-information_mt.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> Nederlands (NL) <span class="fw-normal"> (783.51 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/nl/documents/product-information/nintedanib-accord-epar-product-information_nl.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> norsk (NO) <span class="fw-normal"> (831.81 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/no/documents/product-information/nintedanib-accord-epar-product-information_no.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> polski (PL) <span class="fw-normal"> (851.17 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/pl/documents/product-information/nintedanib-accord-epar-product-information_pl.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> português (PT) <span class="fw-normal"> (687.21 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/pt/documents/product-information/nintedanib-accord-epar-product-information_pt.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> română (RO) <span class="fw-normal"> (800.81 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/ro/documents/product-information/nintedanib-accord-epar-product-information_ro.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> slovenčina (SK) <span class="fw-normal"> (791.79 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/sk/documents/product-information/nintedanib-accord-epar-product-information_sk.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> slovenščina (SL) <span class="fw-normal"> (766.74 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/sl/documents/product-information/nintedanib-accord-epar-product-information_sl.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> Suomi (FI) <span class="fw-normal"> (1.28 MB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/fi/documents/product-information/nintedanib-accord-epar-product-information_fi.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="pt-3"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> svenska (SV) <span class="fw-normal"> (736.48 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/sv/documents/product-information/nintedanib-accord-epar-product-information_sv.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div></div></div></div></div><div class="product-info-row mt-4-5"><div class="taxonomy-term ema-string-replacement ema-string-replacement--full"><div class="field text-long ema-string-replacement__description"><span class="ema-media-image-wysiwyg me-2 mb-2 float-start"><img src="/sites/default/files/2024-06/Globe-product_information.svg" alt="icon globe" loading="lazy" class="img-fluid"></span><p>This medicine’s product information is available in all<strong> official EU languages</strong>.<br>Select 'available languages' to access the language you need.</p><p> </p><p>Product information documents contain:</p><ul><li>summary of product characteristics (annex I);</li><li>manufacturing authorisation holder responsible for batch release (annex IIA);</li><li>conditions of the marketing authorisation (annex IIB);</li><li>labelling (annex IIIA);</li><li>package leaflet (annex IIIB).</li></ul></div></div></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="all-authorised-presentations" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Nintedanib Accord : EPAR - All authorised presentations</p></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (30.23 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2024-04-22T10:34:10Z">22/04/2024</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/all-authorised-presentations/nintedanib-accord-epar-all-authorised-presentations_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div><div class="file-translations bg-lighter py-3 px-3-5 border-top"><div class="text-center"><a class="standalone" aria-controls="file-language-dropdown-853" data-bs-toggle="collapse" aria-expanded="false" role="button" href="#file-language-dropdown-853">Other languages (24)<svg class="ms-2-5 bi icon--2xs" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#caret-down-fill"/></svg></a></div><div class="collapse" id="file-language-dropdown-853"><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> български (BG) <span class="fw-normal"> (58.84 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/bg/documents/all-authorised-presentations/nintedanib-accord-epar-all-authorised-presentations_bg.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> español (ES) <span class="fw-normal"> (16.49 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">22/04/2024</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/es/documents/all-authorised-presentations/nintedanib-accord-epar-all-authorised-presentations_es.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div><div class="py-3 border-bottom"><div class="d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> čeština (CS) <span class="fw-normal"> (54.84 KB - 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A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see <a href="/node/69107">Generic and hybrid medicines</a>.</p></div></dd><dt class="pb-1 pb-md-2-5 ps-0 pe-4"><div> Marketing authorisation holder </div></dt><dd class="ps-md-2 pe-2 pb-3 pb-md-2-5"><div> Accord Healthcare S.L.U.<p>Edificio Este Planta 6a<br /> World Trade Center<br /> Moll De Barcelona S/n<br /> 08039 Barcelona<br /> SPAIN</p></div></dd><dt class="pb-1 pb-md-2-5 ps-0 pe-4"><div> Opinion adopted </div></dt><dd class="ps-md-2 pe-2 pb-3 pb-md-2-5"><div> 22/02/2024 </div></dd><dt class="pb-1 pb-md-2-5 ps-0 pe-4"><div> Marketing authorisation issued </div></dt><dd class="ps-md-2 pe-2 pb-3 pb-md-2-5"><div> 19/04/2024 </div></dd><dt class="pb-1 pb-md-2-5 ps-0 pe-4"><div> Revision </div></dt><dd class="ps-md-2 pe-2 pb-3 pb-md-2-5"><div> 1 </div></dd></dl></div></div><div id="ema-inpage-item-assessment-history" data-section="assessment-history" class="section assessment-history main-section"><h2 id="assessment-history" class="h2 rounded-title">Assessment history</h2><div class="mt-3"><div class="accordion" id="accordion-bcl-accordion--2"><div class="accordion-items-wrapper"><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--2-1"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--2-1" aria-controls="collapse-bcl-accordion--2-1" aria-expanded="false" type="button" >Changes since initial authorisation of medicine</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--2-1" aria-labelledby="heading-bcl-accordion--2-1" role="region"><div class="accordion-body"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="procedural-steps-after" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Nintedanib Accord : EPAR - Procedural steps taken and scientific information after authorisation</p></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (138.7 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2024-06-20T14:32:00Z">20/06/2024</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/procedural-steps-after/nintedanib-accord-epar-procedural-steps-taken-scientific-information-after-authorisation_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div></div></div></div></div></div></div></div><div class="mt-3"><div class="accordion" id="accordion-bcl-accordion--3"><div class="accordion-items-wrapper"><div class="accordion-item"><h2 class="accordion-header" id="heading-bcl-accordion--3-1"><button class="accordion-button collapsed" data-bs-toggle="collapse" autocomplete="off" data-bs-target="#collapse-bcl-accordion--3-1" aria-controls="collapse-bcl-accordion--3-1" aria-expanded="false" type="button" >Initial marketing authorisation documents</button></h2><div class="accordion-collapse collapse" id="collapse-bcl-accordion--3-1" aria-labelledby="heading-bcl-accordion--3-1" role="region"><div class="accordion-body"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="assessment-report" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">Nintedanib Accord : EPAR - Public assessment report</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Adopted</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/108684/2024</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (402.32 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2024-04-22T10:36:14Z">22/04/2024</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/assessment-report/nintedanib-accord-epar-public-assessment-report_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="smop-initial" class="bcl-file variant-default border rounded overflow-hidden"><div class="file-title-metadata px-3-5 py-3"><div class="d-flex"><div class="pe-2 pb-2 icon-wrapper"><svg class="mt-1 icon--file text-dark bi icon--2xl" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#file-pdf"/></svg></div><div class="d-md-flex flex-grow-1 ms-2-5"><div class="flex-grow-1"><p class="file-title mb-1 fw-bold">CHMP summary of positive opinion for Nintedanib Accord</p><div class="file-metadata d-grid gap-2 gap-md-0"><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row fw-normal text-muted"><span class="value">Adopted</span></small><small class="file-metadata-row w-100 d-flex gap-2 flex-column flex-sm-row reference-number fw-normal text-muted"><span class="label">Reference Number: </span><span class="value">EMA/CHMP/34939/2024</span></small></div></div></div></div></div><div class="file-language-links px-3-5 py-3 border-top d-flex flex-column flex-md-row flex-wrap justify-content-between align-items-start align-items-md-center"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> English (EN) <span class="fw-normal"> (151.44 KB - PDF)</span></p><div class="dates-metadata d-grid d-lg-flex flex-lg-row gap-1 gap-lg-3 align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value"><time datetime="2024-02-23T12:00:00Z">23/02/2024</time></span></small></div></div><a target="_blank" class="standalone align-self-top d-inline-block mt-3-5 mt-md-0 flex-shrink-0" href="/en/documents/smop-initial/chmp-summary-positive-opinion-nintedanib-accord_en.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bootstrap-icons.svg#eye"/></svg></a></div></div></div></div></div></div></div></div></div></div><div id="ema-inpage-item-news-on" data-section="news-on" class="section news-on secondary-section"><h4 id="news-on" class="h4 rounded-title">News on Nintedanib Accord</h4><div class="medicine-block related-news spaced-container"><div class="views-row"><div class="views-field views-field-title"><span class="field-content"><a href="/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-february-2024" hreflang="en">Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2024</a></span></div><div class="views-field views-field-field-ema-public-date"><div class="field-content"><time datetime="2024-02-23T11:00:00Z">23/02/2024</time></div></div></div></div></div><div id="ema-inpage-item-revision-date" data-section="revision-date" class="section revision-date 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