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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span class="ema-bg-medicine-status badge rounded-pill bg-danger" title="Withdrawn"><span class="label">Withdrawn</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 Zynrelef</a></li><li class="nav-item" ><a class="nav-link" href="#more-information-on-zynrelef-63760">More information on Zynrelef</a></li><li class="nav-item" ><a class="nav-link" href="#related-medicines">More information on Zynrelef</a></li><li class="nav-item" ><a class="nav-link" href="#topics">Topics</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>Zynrelef is a painkiller used in adults to reduce pain from small to medium-sized wounds after an operation. It contains the active substances bupivacaine and meloxicam.</p><div class="mt-3"><div class="accordion d-flex flex-column" id="accordion-bcl-accordion"><div class="accordion-buttons d-flex flex-row align-items-center justify-content-end gap-3 mb-3"><button class="btn btn-primary" type="button" role="button" data-trigger="expand-section" aria-label="Expand content in section">Expand section</button><button class="btn btn-light" type="button" role="button" data-trigger="collapse-section" aria-label="Collapse content in section">Collapse section</button></div><script type="text/javascript"> document.querySelectorAll('#accordion-bcl-accordion [data-trigger]').forEach((button) => { button.addEventListener('click', event => { const item = event.target, action = item.getAttribute('data-trigger'), old_action_texts = item.querySelectorAll('.action-text'), action_text = document.createElement('span'), accordion = item.closest('#accordion-bcl-accordion'), accordion_items = accordion.querySelectorAll('.accordion-collapse'), action_message = (action === 'expand-section' ? "Expanded content in section" : "Collapsed content in section"); old_action_texts.forEach((old_action_text) => { old_action_text.remove(); }); action_text.classList.add('visually-hidden'); action_text.classList.add('action-text'); action_text.setAttribute('role', 'alert'); action_text.setAttribute('aria-live', 'polite'); action_text.setAttribute('aria-atomic', true); item.appendChild(action_text); action_text.textContent = action_message; accordion_items.forEach((accordion_item) => { if (action === 'expand-section') { bootstrap.Collapse.getOrCreateInstance(accordion_item, { toggle: false }).show(); } else if (action === 'collapse-section') { bootstrap.Collapse.getOrCreateInstance(accordion_item, { toggle: false }).hide(); } }); }, false); }); </script><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 Zynrelef 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>Zynrelef is a prolonged-release solution that is applied to the wound during surgery before the wound is closed. Prolonged-release means that the active substances are released slowly over several hours after application.</p><p>The medicine can only be obtained with a prescription and it should be used in a setting (such as a hospital) where trained staff and equipment are available to treat patients who get side effects involving the heart or central nervous system.</p><p>For more information about using Zynrelef, 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 Zynrelef 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>Bupivacaine is a local anaesthetic which temporarily numbs the area to which it has been applied by blocking pain signals to the brain. Meloxicam, a non-steroidal anti-inflammatory drug (NSAID), reduces pain and inflammation and strengthens the effect of bupivacaine. </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>What benefits of Zynrelef have been shown in studies?</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><a>Two main studies in 830 patients have shown that Zynrelef is effective at reducing pain from small to medium-sized wounds following surgery. The main measure of effectiveness was a total pain score for a 72-hour period, with lower scores indicating better pain control.</a></p><p>In the first study involving patients who had surgery to remove a bunion, the pain score in patients treated with Zynrelef was 323 compared with 445 for patients receiving placebo (a dummy treatment) and 393 for patients receiving bupivacaine (standard treatment). In the second study involving patients who had surgery to repair a hernia, the pain score was 269 with Zynrelef compared with 351 for patients receiving placebo and 342 for patients receiving bupivacaine. In both these studies Zynrelef had some effect in reducing the use of opioid pain medication after surgery.</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 risks associated with Zynrelef?</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>The most common side effect with Zynrelef (which may affect more than 1 in 10 people) is dizziness.</p><p>Zynrelef should not be used in patients with hypersensitivity (allergy) to the active substances or to any amide-type local anaesthetic or an NSAID including acetylsalicylic acid (also known as aspirin). The medicine should also not be used in women during the last 3 months of pregnancy, in patients who have undergone certain heart surgeries or who have severe heart failure (when the heart does not pump as well as it should), poor liver function or severe kidney failure (inability of the kidneys to work properly) that is not being treated with dialysis (to remove unwanted fluids and substances from the blood).</p><p>For the full list of side effects and restrictions with Zynrelef, see the package leaflet.</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 Zynrelef 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>Zynrelef has been shown to provide effective pain relief from small to medium-sized wounds after surgery. Its effect on reducing the need for opioid pain relief was considered modest but clinically significant. The medicine鈥檚 side effects are similar to those of bupivacaine alone and are considered manageable. The European Medicines Agency therefore decided that Zynrelef鈥檚 benefits are greater than its 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 Zynrelef?</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 Zynrelef have been included in the summary of product characteristics and the package leaflet.</p><p>As for all medicines, data on the use of Zynrelef are continuously monitored. Side effects reported with the medicine 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 Zynrelef</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>Zynrelef received a marketing authorisation valid throughout the EU on 24 September 2020.</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">Zynrelef : 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/497953/2020</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"> (186.35 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="2020-10-06T17:49:00Z">06/10/2020</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2023-11-22T12:00:00Z">22/11/2023</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/zynrelef-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-734" data-bs-toggle="collapse" aria-expanded="false" 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class="language-meta mb-1 fw-bold"> latvie拧u valoda (LV) <span class="fw-normal"> (227.13 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/lv/documents/overview/zynrelef-epar-medicine-overview_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"> lietuvi懦 kalba (LT) <span class="fw-normal"> (219.14 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/lt/documents/overview/zynrelef-epar-medicine-overview_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"> (213.65 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/hu/documents/overview/zynrelef-epar-medicine-overview_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"> (226.26 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/mt/documents/overview/zynrelef-epar-medicine-overview_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"> (186.76 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/nl/documents/overview/zynrelef-epar-medicine-overview_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"> polski (PL) <span class="fw-normal"> (220.83 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/pl/documents/overview/zynrelef-epar-medicine-overview_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"> portugu锚s (PT) <span class="fw-normal"> (186.6 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/pt/documents/overview/zynrelef-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"> rom芒n膬 (RO) <span class="fw-normal"> (218.59 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/ro/documents/overview/zynrelef-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"> sloven膷ina (SK) <span class="fw-normal"> (218.16 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/sk/documents/overview/zynrelef-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"> sloven拧膷ina (SL) <span class="fw-normal"> (218.63 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/sl/documents/overview/zynrelef-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"> (176.91 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/fi/documents/overview/zynrelef-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"> (178.48 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/sv/documents/overview/zynrelef-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-summary" 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">Zynrelef : EPAR - Risk-management-plan summary</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"> (248.47 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="2020-10-06T18:00:00Z">06/10/2020</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2023-11-22T12:00:00Z">22/11/2023</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-summary/zynrelef-epar-risk-management-plan-summary_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">Zynrelef : 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"> (2.03 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"><time datetime="2020-10-06T17:52:00Z">06/10/2020</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2023-11-22T12:00:00Z">22/11/2023</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/zynrelef-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-44" data-bs-toggle="collapse" aria-expanded="false" role="button" href="#file-language-dropdown-44">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-44"><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"> 斜褗谢谐邪褉褋泻懈 (BG) <span class="fw-normal"> (2.23 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/bg/documents/product-information/zynrelef-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"> espa帽ol (ES) <span class="fw-normal"> (1.92 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/es/documents/product-information/zynrelef-epar-product-information_es.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use 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target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/da/documents/product-information/zynrelef-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"> (2.09 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/de/documents/product-information/zynrelef-epar-product-information_de.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"> eesti keel (ET) <span class="fw-normal"> (1.92 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal 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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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/is/documents/product-information/zynrelef-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"> (1.97 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/it/documents/product-information/zynrelef-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 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class="d-flex flex-column flex-wrap"><div class="d-flex flex-column flex-wrap"><p class="language-meta mb-1 fw-bold"> lietuvi懦 kalba (LT) <span class="fw-normal"> (2.12 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/lt/documents/product-information/zynrelef-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"> (2.19 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/hu/documents/product-information/zynrelef-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"> (2.61 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/mt/documents/product-information/zynrelef-epar-product-information_mt.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use 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class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/pl/documents/product-information/zynrelef-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"> portugu锚s (PT) <span class="fw-normal"> (1.88 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/pt/documents/product-information/zynrelef-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"> rom芒n膬 (RO) <span class="fw-normal"> (2.21 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/ro/documents/product-information/zynrelef-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"> sloven膷ina (SK) <span class="fw-normal"> (2.34 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 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align-content-start"><small class="metadata-row first-published fw-normal text-muted"><strong class="label">First published: </strong><span class="value">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/sl/documents/product-information/zynrelef-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"> (2.07 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/fi/documents/product-information/zynrelef-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"> (1.86 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/sv/documents/product-information/zynrelef-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"><strong>Latest procedure affecting product information:</strong> PSUSA/00010880/202303 </div><div class="product-info-row mt-2"> 05/10/2023 </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鈥檚 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">Zynrelef : EPAR - All authorised presentation</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"> (54.21 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"><time 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class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/es/documents/all-authorised-presentations/zynrelef-epar-all-authorised-presentation_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"> 膷e拧tina (CS) <span class="fw-normal"> (89.86 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">06/10/2020</span></small><small class="metadata-row last-updated 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class="value">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/da/documents/all-authorised-presentations/zynrelef-epar-all-authorised-presentation_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"> (63.42 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 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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"> 铆slenska (IS) <span class="fw-normal"> (62.58 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/is/documents/all-authorised-presentations/zynrelef-epar-all-authorised-presentation_is.pdf">View<svg class="ms-2-5 bi icon--fluid" ><use 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class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/lv/documents/all-authorised-presentations/zynrelef-epar-all-authorised-presentation_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"> lietuvi懦 kalba (LT) <span class="fw-normal"> (86.04 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">06/10/2020</span></small><small class="metadata-row 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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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/nl/documents/all-authorised-presentations/zynrelef-epar-all-authorised-presentation_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"> 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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"> rom芒n膬 (RO) <span class="fw-normal"> (80.94 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/ro/documents/all-authorised-presentations/zynrelef-epar-all-authorised-presentation_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"> sloven膷ina (SK) <span class="fw-normal"> (78.49 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/sk/documents/all-authorised-presentations/zynrelef-epar-all-authorised-presentation_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"> sloven拧膷ina (SL) <span class="fw-normal"> (82.08 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/sl/documents/all-authorised-presentations/zynrelef-epar-all-authorised-presentation_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"> (63.77 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/fi/documents/all-authorised-presentations/zynrelef-epar-all-authorised-presentation_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"> (62.89 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">06/10/2020</span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value">22/11/2023</span></small></div></div></div><a target="_blank" class="d-block standalone mt-3-5 mt-md-0" href="/sv/documents/all-authorised-presentations/zynrelef-epar-all-authorised-presentation_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><div id="ema-inpage-item-product-details" data-section="product-details" class="section product-details main-section"><h2 id="product-details" class="h2 rounded-title">Product details</h2><div class="description-list"><dl class="horizontal d-md-grid grid-4-8"><dt class="pb-1 pb-md-2-5 ps-0 pe-4"><div> Name of medicine </div></dt><dd class="ps-md-2 pe-2 pb-3 pb-md-2-5"><div> Zynrelef </div></dd><dt class="pb-1 pb-md-2-5 ps-0 pe-4"><div> Active substance </div></dt><dd class="ps-md-2 pe-2 pb-3 pb-md-2-5"><div><ul><li>bupivacaine</li><li>meloxicam</li></ul></div></dd><dt class="pb-1 pb-md-2-5 ps-0 pe-4"><div> International non-proprietary name (INN) or common name </div></dt><dd class="ps-md-2 pe-2 pb-3 pb-md-2-5"><div><ul><li>bupivacaine</li><li>meloxicam</li></ul></div></dd><dt class="pb-1 pb-md-2-5 ps-0 pe-4"><div> Therapeutic area (MeSH) </div></dt><dd class="ps-md-2 pe-2 pb-3 pb-md-2-5"><div> Pain, Postoperative </div></dd><dt class="pb-1 pb-md-2-5 ps-0 pe-4"><div> Anatomical therapeutic chemical (ATC) code </div></dt><dd class="ps-md-2 pe-2 pb-3 pb-md-2-5"><div> N01B </div></dd></dl></div><div class="subsection mt-3-5"><h3>Pharmacotherapeutic group</h3> Anesthetics </div><div class="subsection mt-3-5"><h3>Therapeutic indication</h3><p>Zynrelef is indicated for treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults (see section 5.1).</p></div></div><div id="ema-inpage-item-authorisation-details" data-section="authorisation-details" class="section authorisation-details main-section"><h2 id="authorisation-details" class="h2 rounded-title">Authorisation details</h2><div class="description-list"><dl class="horizontal d-md-grid grid-4-8"><dt class="pb-1 pb-md-2-5 ps-0 pe-4"><div> EMA product number </div></dt><dd class="ps-md-2 pe-2 pb-3 pb-md-2-5"><div> EMEA/H/C/005205 </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> Heron Therapeutics, B.V.<p>Herengracht 500<br />1017CB Amsterdam<br />Netherlands</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> 23/07/2020 </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> 24/09/2020 </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> 3 </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">Zynrelef : 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"> (300.01 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="2022-06-16T16:43:00Z">16/06/2022</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2023-11-22T12:00:00Z">22/11/2023</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/zynrelef-epar-procedural-steps-taken-and-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 class="mt-4 ema-file-wrapper"><div data-ema-document-type="scientific-conclusion" 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">Zynrelef-H-C-PSUSA-00010880-202209 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation</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/192804/2023</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"> (187.81 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"><time datetime="2023-06-28T17:18:00Z">28/06/2023</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2023-11-22T12:00:00Z">22/11/2023</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/scientific-conclusion/zynrelef-h-c-psusa-00010880-202209-epar-scientific-conclusions-and-grounds-variation-terms-marketing-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">Zynrelef : 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/CHMP/450646/2020</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"> (10.11 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"><time datetime="2020-10-06T17:58:00Z">06/10/2020</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2023-11-22T12:00:00Z">22/11/2023</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/zynrelef-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 Zynrelef</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/367342/2020 </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"> (157.86 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"><time datetime="2020-07-24T12:00:00Z">24/07/2020</time></span></small><small class="metadata-row last-updated fw-normal text-muted"><strong class="label">Last updated: </strong><span class="value"><time datetime="2023-11-22T12:00:00Z">22/11/2023</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-zynrelef_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 Zynrelef</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-20-23-july-2020" hreflang="en">Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020</a></span></div><div class="views-field views-field-field-ema-public-date"><div class="field-content"><time datetime="2020-07-24T10:10:00Z">24/07/2020</time></div></div></div></div></div><div id="ema-inpage-item-more-info-63760" data-section="related-content" class="section related-content"><div class="paragraph paragraph--type--ema-documents paragraph--view-mode--related-content" id="ema-inpage-item-63760"><div id="more-information-on-zynrelef-63760"><h4 class="mb-3 rounded-title"> More information on Zynrelef </h4></div><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="public-statement" 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">Zynrelef: public statement - Withdrawal of the marketing authorisation in the European Union</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/453895/2023</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"> (116.8 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="2023-12-19T08:21:00Z">19/12/2023</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/public-statement/zynrelef-public-statement-withdrawal-marketing-authorisation-european-union_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 id="ema-inpage-item-related-medicines" data-section="related-medicines" class="section related-medicines secondary-section"><h4 id="related-medicines" class="h4 rounded-title">More information on <span>Zynrelef</span></h4><ul><li><a href="/en/medicines/human/paediatric-investigation-plans/emea-002246-pip01-17-m03" hreflang="en">EMEA-002246-PIP01-17-M03 - paediatric investigation plan</a></li></ul></div><div id="ema-inpage-item-topics" data-section="topics" class="section topics secondary-section"><h4 id="topics" class="h4 rounded-title">Topics</h4><div class="views-element-container"><div class="ema-topics-list mb-4 js-view-dom-id-34aff42492a66deda532a5fb06063291e555ac4fbf57453374ddd69cfa4ce203"><div class="item-list"><ul><li><div class="views-field views-field-name"><span class="field-content"><a 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