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class="col"><div class="heading-title"><h1 class="content-banner-title card-title bcl-heading"><span>EMEA-002246-PIP01-17-M03 - paediatric investigation plan</span></h1></div><div class="heading-actions align-self-stretch d-flex justify-content-end"><div class="action-bar"><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="card-content-block"><div class="card-content-wrapper"><div class="content"><span class="fst-italic"><div class="field entity-reference ema-pip__field-ema-active-substance multiple"><div class="field__items"><div class="field__item">bupivacaine</div><div class="field__item">meloxicam (HTX-011)</div></div></div></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="PIP"><span class="label">PIP</span></span><span class="ema-bg-category badge rounded-pill badge-outline-primary" title="Human"><span class="label">Human</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-pip ema-pip--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="#key-facts">Key facts</a></li><li class="nav-item" ><a class="nav-link" href="#decision">Decision</a></li><li class="nav-item" ><a class="nav-link" href="#related-medicines">Related content</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 id="ema-inpage-item-key-facts" data-section="key-facts" class="section key-facts main-section"><h2 id="key-facts" class="h2 rounded-title">Key facts</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 field-ema-invented-name"><div> Invented name </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 field-ema-active-substance"><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 (HTX-011)</li></ul></div></dd><dt class="pb-1 pb-md-2-5 ps-0 pe-4 field-ema-pip-therapeutic-area"><div> Therapeutic area </div></dt><dd class="ps-md-2 pe-2 pb-3 pb-md-2-5"><div> Pain </div></dd><dt class="pb-1 pb-md-2-5 ps-0 pe-4 field-ema-pip-emea-decision-no"><div> Decision number </div></dt><dd class="ps-md-2 pe-2 pb-3 pb-md-2-5"><div> P/0160/2023 </div></dd><dt class="pb-1 pb-md-2-5 ps-0 pe-4 title"><div> PIP number </div></dt><dd class="ps-md-2 pe-2 pb-3 pb-md-2-5"><div> EMEA-002246-PIP01-17-M03 </div></dd><dt class="pb-1 pb-md-2-5 ps-0 pe-4 field-ema-pip-pharm-form"><div> Pharmaceutical form(s) </div></dt><dd class="ps-md-2 pe-2 pb-3 pb-md-2-5"><div> Solution for injection </div></dd><dt class="pb-1 pb-md-2-5 ps-0 pe-4 field-ema-pip-conditions"><div> Condition(s) / indication(s) </div></dt><dd class="ps-md-2 pe-2 pb-3 pb-md-2-5"><div> Treatment of acute postoperative pain </div></dd><dt class="pb-1 pb-md-2-5 ps-0 pe-4 field-ema-pip-route-admin"><div> Route(s) of administration </div></dt><dd class="ps-md-2 pe-2 pb-3 pb-md-2-5"><div><ul><li>Application to surgical site</li><li>Intralesional use</li></ul></div></dd><dt class="pb-1 pb-md-2-5 ps-0 pe-4 field-ema-pip-applicant"><div> Contact for public enquiries </div></dt><dd class="ps-md-2 pe-2 pb-3 pb-md-2-5"><div><div id="taxonomy-term-66893" class="taxonomy-term ema-pip-applicant ema-pip-applicant--ema-only-description"><div class="field text-long ema-pip-applicant__description"><p>Heron Therapeutics B.V.</p><p>E-mail: <a href="mailto:HTX011-ct@herontx.com">HTX011-ct@herontx.com</a><br />Tel: +1 8582514420</p></div></div></div></dd><dt class="pb-1 pb-md-2-5 ps-0 pe-4 field-ema-pip-decision-type"><div> Decision type </div></dt><dd class="ps-md-2 pe-2 pb-3 pb-md-2-5"><div> PM: decision on the application for modification of an agreed PIP </div></dd><dt class="pb-1 pb-md-2-5 ps-0 pe-4 field-ema-decision-date"><div> Decision date </div></dt><dd class="ps-md-2 pe-2 pb-3 pb-md-2-5"><div><div class="field datetime ema-pip__field-ema-decision-date"><time datetime="2023-05-12T12:00:00Z">12/05/2023</time></div></div></dd></dl></div></div><div id="ema-inpage-item-decision" data-section="decision" class="section decision main-section"><h2 id="decision" class="h2 rounded-title">Decision</h2><div class="item"><div class="paragraph paragraph--type--ema-documents paragraph--view-mode--ema-grouped-items" id="ema-inpage-item-35573"><div class="mt-4 ema-file-wrapper"><div data-ema-document-type="pip-decision" 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">P/0160/2023: Decision of 12 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for bupivacaine / meloxicam (Zynrelef), (EMEA-002246-PIP01-17-M03)</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/170272/2023</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"> (218.44 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="2024-05-28T14:14:00Z">28/05/2024</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/pip-decision/p-0160-2023-decision-12-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-bupivacaine-meloxicam-zynrelef-emea-002246-pip01-17-m03_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 id="ema-inpage-item-related-medicines" data-section="related-medicines" class="section related-medicines secondary-section"><h4 id="related-medicines" class="h4 rounded-title">Related content</h4><ul><li><a 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