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data-drupal-facet-item-id="ema-search-topics-42" data-drupal-facet-item-value="42" data-drupal-facet-item-count="405"><span class="facet-item__value">Advanced therapies</span><span class="facet-item__count">(405)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A43" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-43" data-drupal-facet-item-value="43" data-drupal-facet-item-count="47"><span class="facet-item__value">Antimicrobial resistance</span><span class="facet-item__count">(47)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A44" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-44" data-drupal-facet-item-value="44" data-drupal-facet-item-count="24"><span class="facet-item__value">Biologicals</span><span class="facet-item__count">(24)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A45" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-45" data-drupal-facet-item-value="45" data-drupal-facet-item-count="169"><span class="facet-item__value">Biosimilars</span><span class="facet-item__count">(169)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A46" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-46" data-drupal-facet-item-value="46" data-drupal-facet-item-count="30"><span class="facet-item__value">Brexit</span><span class="facet-item__count">(30)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A47" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-47" data-drupal-facet-item-value="47" data-drupal-facet-item-count="3"><span class="facet-item__value">Careers</span><span class="facet-item__count">(3)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A48" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-48" data-drupal-facet-item-value="48" data-drupal-facet-item-count="206"><span class="facet-item__value">Clinical trials</span><span class="facet-item__count">(206)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A49" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-49" data-drupal-facet-item-value="49" data-drupal-facet-item-count="4"><span class="facet-item__value">Compassionate use</span><span class="facet-item__count">(4)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A50" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-50" data-drupal-facet-item-value="50" data-drupal-facet-item-count="106"><span class="facet-item__value">Compliance and inspections</span><span class="facet-item__count">(106)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A67969" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-67969" data-drupal-facet-item-value="67969" data-drupal-facet-item-count="68"><span class="facet-item__value">Corporate</span><span class="facet-item__count">(68)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A61132" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-61132" data-drupal-facet-item-value="61132" data-drupal-facet-item-count="469"><span class="facet-item__value">COVID-19</span><span class="facet-item__count">(469)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A51" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-51" data-drupal-facet-item-value="51" data-drupal-facet-item-count="188"><span class="facet-item__value">Data on medicines</span><span class="facet-item__count">(188)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A52" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-52" data-drupal-facet-item-value="52" data-drupal-facet-item-count="25"><span class="facet-item__value">Early access</span><span class="facet-item__count">(25)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A53" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-53" data-drupal-facet-item-value="53" data-drupal-facet-item-count="16"><span class="facet-item__value">Fees</span><span class="facet-item__count">(16)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A54" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-54" data-drupal-facet-item-value="54" data-drupal-facet-item-count="405"><span class="facet-item__value">Generic and hybrid medicines</span><span class="facet-item__count">(405)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A55" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-55" data-drupal-facet-item-value="55" data-drupal-facet-item-count="99"><span class="facet-item__value">Governance</span><span class="facet-item__count">(99)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A57" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-57" data-drupal-facet-item-value="57" data-drupal-facet-item-count="283"><span class="facet-item__value">Innovation</span><span class="facet-item__count">(283)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A58" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-58" data-drupal-facet-item-value="58" data-drupal-facet-item-count="19"><span class="facet-item__value">Maximum residue limit</span><span class="facet-item__count">(19)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A105060" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-105060" data-drupal-facet-item-value="105060" data-drupal-facet-item-count="32"><span class="facet-item__value">Medical devices</span><span class="facet-item__count">(32)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A59" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-59" data-drupal-facet-item-value="59" data-drupal-facet-item-count="7"><span class="facet-item__value">Medication error</span><span class="facet-item__count">(7)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A61" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-61" data-drupal-facet-item-value="61" data-drupal-facet-item-count="8168"><span class="facet-item__value">Medicines</span><span class="facet-item__count">(8168)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A62" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-62" data-drupal-facet-item-value="62" data-drupal-facet-item-count="33"><span class="facet-item__value">Medicines for use outside the EU</span><span class="facet-item__count">(33)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A60" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-60" data-drupal-facet-item-value="60" data-drupal-facet-item-count="222"><span class="facet-item__value">Medicine shortages</span><span class="facet-item__count">(222)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A67812" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-67812" data-drupal-facet-item-value="67812" data-drupal-facet-item-count="19"><span class="facet-item__value">Mpox</span><span class="facet-item__count">(19)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A65" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-65" data-drupal-facet-item-value="65" data-drupal-facet-item-count="3256"><span class="facet-item__value">Paediatrics</span><span class="facet-item__count">(3256)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A66" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-66" data-drupal-facet-item-value="66" data-drupal-facet-item-count="6"><span class="facet-item__value">Parallel distribution</span><span class="facet-item__count">(6)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A67" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-67" data-drupal-facet-item-value="67" data-drupal-facet-item-count="3104"><span class="facet-item__value">Pharmacovigilance</span><span class="facet-item__count">(3104)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A68" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-68" data-drupal-facet-item-value="68" data-drupal-facet-item-count="11"><span class="facet-item__value">Procurement</span><span class="facet-item__count">(11)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A69" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-69" data-drupal-facet-item-value="69" data-drupal-facet-item-count="68"><span class="facet-item__value">Product information</span><span class="facet-item__count">(68)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A70" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-70" data-drupal-facet-item-value="70" data-drupal-facet-item-count="94"><span class="facet-item__value">Quality of medicines</span><span class="facet-item__count">(94)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A64" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-64" data-drupal-facet-item-value="64" data-drupal-facet-item-count="3400"><span class="facet-item__value">Rare diseases</span><span class="facet-item__count">(3400)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A71" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-71" data-drupal-facet-item-value="71" data-drupal-facet-item-count="400"><span class="facet-item__value">Referrals</span><span class="facet-item__count">(400)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A56" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-56" data-drupal-facet-item-value="56" data-drupal-facet-item-count="567"><span class="facet-item__value">Regulatory and procedural guidance</span><span class="facet-item__count">(567)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A72" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-72" data-drupal-facet-item-value="72" data-drupal-facet-item-count="230"><span class="facet-item__value">Research and development</span><span class="facet-item__count">(230)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A73" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-73" data-drupal-facet-item-value="73" data-drupal-facet-item-count="38"><span class="facet-item__value">Scientific advice</span><span class="facet-item__count">(38)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A74" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-74" data-drupal-facet-item-value="74" data-drupal-facet-item-count="1030"><span class="facet-item__value">Scientific guidelines</span><span class="facet-item__count">(1030)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A75" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-75" data-drupal-facet-item-value="75" data-drupal-facet-item-count="64"><span class="facet-item__value">SME</span><span class="facet-item__count">(64)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A76" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-76" data-drupal-facet-item-value="76" data-drupal-facet-item-count="394"><span class="facet-item__value">Vaccines</span><span class="facet-item__count">(394)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_topics%3A63" rel="nofollow" data-drupal-facet-item-id="ema-search-topics-63" data-drupal-facet-item-value="63" data-drupal-facet-item-count="15"><span class="facet-item__value">Veterinary limited markets</span><span class="facet-item__count">(15)</span></a></li></ul></div></div><div class="facet-inactive block-facet--checkbox ema-facet-block mb-3" id="block-facet-block-ema-search-responsible-body"><div class="facets-widget-checkbox"><legend class="col-form-label"><span class="fieldset-legend">Responsible body</span></legend><ul data-drupal-facet-id="ema_search_responsible_body" data-drupal-facet-alias="ema_search_responsible_body" class="facet-inactive js-facets-checkbox-links facet checkbox-widget item-list__checkbox"><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_responsible_body%3A100002" rel="nofollow" data-drupal-facet-item-id="ema-search-responsible-body-100002" data-drupal-facet-item-value="100002" data-drupal-facet-item-count="1036"><span class="ms-2 form-check-label facet-item__value">CHMP</span><span class="facet-item__count">(1036)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_responsible_body%3A100006" rel="nofollow" data-drupal-facet-item-id="ema-search-responsible-body-100006" data-drupal-facet-item-value="100006" data-drupal-facet-item-count="585"><span class="ms-2 form-check-label facet-item__value">CVMP</span><span class="facet-item__count">(585)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_responsible_body%3A100010" rel="nofollow" data-drupal-facet-item-id="ema-search-responsible-body-100010" data-drupal-facet-item-value="100010" data-drupal-facet-item-count="441"><span class="ms-2 form-check-label facet-item__value">PRAC</span><span class="facet-item__count">(441)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_responsible_body%3A100005" rel="nofollow" data-drupal-facet-item-id="ema-search-responsible-body-100005" data-drupal-facet-item-value="100005" data-drupal-facet-item-count="288"><span class="ms-2 form-check-label facet-item__value">COMP</span><span class="facet-item__count">(288)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_responsible_body%3A100009" rel="nofollow" data-drupal-facet-item-id="ema-search-responsible-body-100009" data-drupal-facet-item-value="100009" data-drupal-facet-item-count="270"><span class="ms-2 form-check-label facet-item__value">PDCO</span><span class="facet-item__count">(270)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_responsible_body%3A100001" rel="nofollow" data-drupal-facet-item-id="ema-search-responsible-body-100001" data-drupal-facet-item-value="100001" data-drupal-facet-item-count="231"><span class="ms-2 form-check-label facet-item__value">CAT</span><span class="facet-item__count">(231)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_responsible_body%3A100008" rel="nofollow" data-drupal-facet-item-id="ema-search-responsible-body-100008" data-drupal-facet-item-value="100008" data-drupal-facet-item-count="197"><span class="ms-2 form-check-label facet-item__value">Management Board</span><span class="facet-item__count">(197)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_responsible_body%3A100007" rel="nofollow" data-drupal-facet-item-id="ema-search-responsible-body-100007" data-drupal-facet-item-value="100007" data-drupal-facet-item-count="132"><span class="ms-2 form-check-label facet-item__value">HMPC</span><span class="facet-item__count">(132)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_responsible_body%3A100003" rel="nofollow" data-drupal-facet-item-id="ema-search-responsible-body-100003" data-drupal-facet-item-value="100003" data-drupal-facet-item-count="32"><span class="ms-2 form-check-label facet-item__value">CMDh</span><span class="facet-item__count">(32)</span></a></li><li class="facet-item mb-2"><a href="/en/search?f%5B0%5D=ema_search_responsible_body%3A100004" rel="nofollow" data-drupal-facet-item-id="ema-search-responsible-body-100004" data-drupal-facet-item-value="100004" data-drupal-facet-item-count="0"><span class="ms-2 form-check-label facet-item__value">CMDv</span><span class="facet-item__count">(0)</span></a></li></ul></div></div><div class="facet-inactive block-facet--ema-date-range ema-facet-block mb-3" id="block-facet-block-ema-search-last-updated"><div class="facets-widget-ema_date_range"><legend class="col-form-label"><span class="fieldset-legend">Last updated</span></legend><ul data-drupal-facet-id="ema_search_last_updated" data-drupal-facet-alias="ema_search_last_updated" class="facet-inactive js-ema-date-range-extended-filters facet ema-date-range-widget item-list__ema_date_range"><li class="mb-2"><div class="js-form-item form-item js-form-type-date form-item- js-form-item-"><label for="ema_search_last_updated_min" class="form-label">From:</label><input class="ema-date-range form-date form-control" id="ema_search_last_updated_min" name="ema_search_last_updated_min" data-type="date-range-min" type="date" /><span class="ico"></span></div></li><li class="mb-2"><div class="js-form-item form-item js-form-type-date form-item- js-form-item-"><label for="ema_search_last_updated_max" class="form-label">To:</label><input class="ema-date-range form-date form-control" id="ema_search_last_updated_max" name="ema_search_last_updated_max" data-type="date-range-max" type="date" /><span class="ico"></span></div></li></ul></div></div><div class="facet-inactive block-facet--ema-date-range ema-facet-block mb-3" id="block-facet-block-ema-search-first-published"><div class="facets-widget-ema_date_range"><legend class="col-form-label"><span class="fieldset-legend">First published</span></legend><ul data-drupal-facet-id="ema_search_first_published" data-drupal-facet-alias="ema_search_first_published" class="facet-inactive facet ema-date-range-widget item-list__ema_date_range"><li class="mb-2"><div class="js-form-item form-item js-form-type-date form-item- js-form-item-"><label for="ema_search_first_published_min" class="form-label">From:</label><input class="ema-date-range form-date form-control" id="ema_search_first_published_min" name="ema_search_first_published_min" data-type="date-range-min" type="date" /><span class="ico"></span></div></li><li class="mb-2"><div class="js-form-item form-item js-form-type-date form-item- js-form-item-"><label for="ema_search_first_published_max" class="form-label">To:</label><input class="ema-date-range form-date form-control" id="ema_search_first_published_max" name="ema_search_first_published_max" data-type="date-range-max" type="date" /><span class="ico"></span></div></li></ul></div></div></div></div><button class="d-lg-none w-100 mb-4 btn btn-secondary btn-lg" data-bs-toggle="offcanvas" data-bs-target="#bcl-offcanvas" aria-controls="bcl-offcanvas" type="button" ><svg class="me-2-5 bi icon--fluid" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-bcl-bs-icons_202501.svg#filter"/></svg>Filters</button></div><div id="ema-search-results" class="col-12 col-lg-9"><div class="row"><div class="col-md-6 col-lg-8 align-self-center facets-summary"><h3 class="mb-0 results-count">Search results <span class="source-summary-count">(25492)</span></h3></div></div><div class="row"><div class="col-12"><div id="block-system-main-block" class="main-content"><div class="views-element-container"><hr class="d-none d-md-block mb-4-75"><div class="ema-list-pages oe-list-page--full js-view-dom-id-4509b01a767da2f2a9cd133094f6be23c51b8d42d01afdffac1a46039c1668af search-results mt-n4"><form class="views-exposed-form bef-exposed-form col-lg-4 col-md-6 mt-3 mt-md-0" data-bef-auto-submit-full-form="" data-bef-auto-submit="" data-bef-auto-submit-delay="500" data-drupal-selector="views-exposed-form-ema-search-ema-search-page" action="/en/search" method="get" id="views-exposed-form-ema-search-ema-search-page" accept-charset="UTF-8"><div class="align-items-center d-md-flex float-md-end mb-4 mb-md-0 js-form-item form-item js-form-type-select form-item-sort-bef-combine js-form-item-sort-bef-combine"><label class="mb-0 text-nowrap form-label" for="edit-sort-bef-combine">Sort by</label><select class="ms-md-2 form-select" data-drupal-selector="edit-sort-bef-combine" id="edit-sort-bef-combine" name="sort_bef_combine"><option value="title_ASC">A-Z</option><option value="title_DESC">Z-A</option><option value="field_ema_computed_date_field_ASC">Oldest first</option><option value="field_ema_computed_date_field_DESC" selected="selected">Newest first</option></select><span class="ico"></span></div><div data-drupal-selector="edit-actions" class="form-actions js-form-wrapper form-wrapper" id="edit-actions"><input data-bef-auto-submit-click="" class="js-hide button js-form-submit form-submit btn-secondary btn" data-drupal-selector="edit-submit-ema-search" type="submit" id="edit-submit-ema-search" value="Apply" /></div></form><div class="bcl-listing bcl-listing--default-1-col"><div class="row row-cols-1"><div class="col"><article class="node ema-pip search-index ema-pip--search-index listing-item border-0 m-0 card text-dark"><div class='row'><div class='col-md-12 right-column'><div class="card-body p-0 pb-md-0 pb-3"><div class="teaser-title card-title bcl-heading"><a class="standalone" href="/en/medicines/human/paediatric-investigation-plans/emea-003301-pip01-22-m01">EMEA-003301-PIP01-22-M01 - paediatric investigation plan</a></div><div class="metadata mb-3 me-n3"><div class="metadata-item text-muted me-3"><div class="metadata-field decision-type"><strong class="label">Decision type:</strong> PM: decision on the application for modification of an agreed PIP </div></div><div class="metadata-item text-muted me-3"><div class="metadata-field therapeutic-area"><strong class="label">Therapeutic area:</strong> Dermatology </div></div><div class="metadata-item text-muted me-3"><div class="metadata-field decision-number"><strong class="label">PIP number:</strong> P/0512/2023 </div><div class="metadata-field routes-administration"><strong class="label">Route(s) of administration:</strong> Oral use </div><div class="metadata-field pharmaceutical-form"><strong class="label">Pharmaceutical form(s):</strong> Age-appropriate formulation, Film-coated tablet </div></div><div class="metadata-item text-muted me-3"><div class="metadata-field decision-date"><strong class="label">Decision date:</strong> 29 December 2023 </div><div class="metadata-field last-update"><strong class="label">Last updated:</strong> 17 February 2025 </div><div class="metadata-field compliance-check"><strong class="label">Compliance check:</strong> ✖ </div></div></div><div class="card-badge-wrapper d-flex flex-row flex-wrap gap-2-5 align-items-start mt-3"><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></article></div><div class="col"><article class="node ema-pip search-index ema-pip--search-index listing-item border-0 m-0 card text-dark"><div class='row'><div class='col-md-12 right-column'><div class="card-body p-0 pb-md-0 pb-3"><div class="teaser-title card-title bcl-heading"><a class="standalone" href="/en/medicines/human/paediatric-investigation-plans/emea-003155-pip01-21-m01">EMEA-003155-PIP01-21-M01 - paediatric investigation plan</a></div><div class="metadata mb-3 me-n3"><div class="metadata-item text-muted me-3"><div class="metadata-field decision-type"><strong class="label">Decision type:</strong> PM: decision on the application for modification of an agreed PIP </div></div><div class="metadata-item text-muted me-3"><div class="metadata-field therapeutic-area"><strong class="label">Therapeutic area:</strong> Vaccines </div></div><div class="metadata-item text-muted me-3"><div class="metadata-field decision-number"><strong class="label">PIP number:</strong> P/0510/2023 </div><div class="metadata-field routes-administration"><strong class="label">Route(s) of administration:</strong> Intramuscular use </div><div class="metadata-field pharmaceutical-form"><strong class="label">Pharmaceutical form(s):</strong> Solution for injection in pre-filled syringe </div></div><div class="metadata-item text-muted me-3"><div class="metadata-field decision-date"><strong class="label">Decision date:</strong> 29 December 2023 </div><div class="metadata-field last-update"><strong class="label">Last updated:</strong> 17 February 2025 </div><div class="metadata-field compliance-check"><strong class="label">Compliance check:</strong> ✖ </div></div></div><div class="card-badge-wrapper d-flex flex-row flex-wrap gap-2-5 align-items-start mt-3"><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></article></div><div class="col"><article class="node ema-pip search-index ema-pip--search-index listing-item border-0 m-0 card text-dark"><div class='row'><div class='col-md-12 right-column'><div class="card-body p-0 pb-md-0 pb-3"><div class="teaser-title card-title bcl-heading"><a class="standalone" href="/en/medicines/human/paediatric-investigation-plans/emea-002755-pip01-19-m02">EMEA-002755-PIP01-19-M02 - paediatric investigation plan</a></div><div class="metadata mb-3 me-n3"><div class="metadata-item text-muted me-3"><div class="metadata-field decision-type"><strong class="label">Decision type:</strong> PM: decision on the application for modification of an agreed PIP </div></div><div class="metadata-item text-muted me-3"><div class="metadata-field therapeutic-area"><strong class="label">Therapeutic area:</strong> Infectious diseases </div></div><div class="metadata-item text-muted me-3"><div class="metadata-field decision-number"><strong class="label">PIP number:</strong> P/0523/2023 </div><div class="metadata-field routes-administration"><strong class="label">Route(s) of administration:</strong> Intramuscular use </div><div class="metadata-field pharmaceutical-form"><strong class="label">Pharmaceutical form(s):</strong> Solution for injection </div></div><div class="metadata-item text-muted me-3"><div class="metadata-field decision-date"><strong class="label">Decision date:</strong> 29 December 2023 </div><div class="metadata-field last-update"><strong class="label">Last updated:</strong> 17 February 2025 </div><div class="metadata-field compliance-check"><strong class="label">Compliance check:</strong> ✖ </div></div></div><div class="card-badge-wrapper d-flex flex-row flex-wrap gap-2-5 align-items-start mt-3"><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></article></div><div class="col"><article class="node ema-pip search-index ema-pip--search-index listing-item border-0 m-0 card text-dark"><div class='row'><div class='col-md-12 right-column'><div class="card-body p-0 pb-md-0 pb-3"><div class="teaser-title card-title bcl-heading"><a class="standalone" href="/en/medicines/human/paediatric-investigation-plans/emea-002713-pip02-21-m01">EMEA-002713-PIP02-21-M01 - paediatric investigation plan</a></div><div class="metadata mb-3 me-n3"><div class="metadata-item text-muted me-3"><div class="metadata-field decision-type"><strong class="label">Decision type:</strong> PM: decision on the application for modification of an agreed PIP </div></div><div class="metadata-item text-muted me-3"><div class="metadata-field therapeutic-area"><strong class="label">Therapeutic area:</strong> Gastrointestinal disorders </div></div><div class="metadata-item text-muted me-3"><div class="metadata-field decision-number"><strong class="label">PIP number:</strong> P/0528/2023 </div><div class="metadata-field routes-administration"><strong class="label">Route(s) of administration:</strong> Oral use </div><div class="metadata-field pharmaceutical-form"><strong class="label">Pharmaceutical form(s):</strong> Age-appropriate oral solid dosage form, Film-coated tablet </div></div><div class="metadata-item text-muted me-3"><div class="metadata-field decision-date"><strong class="label">Decision date:</strong> 29 December 2023 </div><div class="metadata-field last-update"><strong class="label">Last updated:</strong> 17 February 2025 </div><div class="metadata-field compliance-check"><strong class="label">Compliance check:</strong> ✖ </div></div></div><div class="card-badge-wrapper d-flex flex-row flex-wrap gap-2-5 align-items-start mt-3"><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></article></div><div class="col"><article class="node ema-medicine search-index ema-medicine--search-index listing-item border-0 m-0 card text-dark"><div class='row'><div class='col-md-12 right-column'><div class="card-body p-0 pb-md-0 pb-3"><div class="teaser-title card-title bcl-heading"><a class="standalone" href="/en/medicines/human/EPAR/daptomycin-hospira">Daptomycin Hospira</a></div><div class="metadata mb-3 me-n3"><div class="metadata-item text-muted me-3"><div class="metadata-field inn-common-name"> daptomycin </div><div class="metadata-field med-therap-area"> Soft Tissue Infections, Skin Diseases, Bacterial </div><div class="metadata-field medicine-icons d-flex flex-row flex-wrap gap-1"><div id="taxonomy-term-43277" class="taxonomy-term ema-string-replacement ema-string-replacement--ema-icon-mode" title="Generic"><svg class="bi icon--s" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-icons/ema-default-icons.svg#icon-checkbox-g"/></svg></div></div></div><div class="metadata-item text-muted me-3"><div class="metadata-field date-authorisation"><strong class="label">Date of authorisation: </strong><time datetime="2017-03-22T12:00:00Z">22 March 2017</time></div><div class="metadata-field ema-revision-number"><strong class="label">Revision: </strong> 14 </div></div><div class="metadata-item text-muted me-3"><div class="metadata-field last-update"><strong class="label">Last updated:</strong> 17 February 2025 </div></div></div><div class="card-badge-wrapper d-flex flex-row flex-wrap gap-2-5 align-items-start mt-3"><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></article></div><div class="col"><article class="node ema-medicine search-index ema-medicine--search-index listing-item border-0 m-0 card text-dark"><div class='row'><div class='col-md-12 right-column'><div class="card-body p-0 pb-md-0 pb-3"><div class="teaser-title card-title bcl-heading"><a class="standalone" href="/en/medicines/human/EPAR/nuvaxovid">Nuvaxovid</a></div><div class="metadata mb-3 me-n3"><div class="metadata-item text-muted me-3"><div class="metadata-field inn-common-name"> COVID-19 Vaccine (recombinant, adjuvanted) </div><div class="metadata-field med-therap-area"> COVID-19 virus infection </div><div class="metadata-field medicine-icons d-flex flex-row flex-wrap gap-1"><div id="taxonomy-term-43273" class="taxonomy-term ema-string-replacement ema-string-replacement--ema-icon-mode" title="Additional monitoring"><svg class="bi icon--s" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-icons/ema-default-icons.svg#icon-checkbox-arrow-down"/></svg></div></div></div><div class="metadata-item text-muted me-3"><div class="metadata-field date-authorisation"><strong class="label">Date of authorisation: </strong><time datetime="2021-12-20T12:00:00Z">20 December 2021</time></div><div class="metadata-field ema-revision-number"><strong class="label">Revision: </strong> 16 </div></div><div class="metadata-item text-muted me-3"><div class="metadata-field last-update"><strong class="label">Last updated:</strong> 17 February 2025 </div></div></div><div class="card-badge-wrapper d-flex flex-row flex-wrap gap-2-5 align-items-start mt-3"><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></article></div><div class="col"><article class="node ema-medicine search-index ema-medicine--search-index listing-item border-0 m-0 card text-dark"><div class='row'><div class='col-md-12 right-column'><div class="card-body p-0 pb-md-0 pb-3"><div class="teaser-title card-title bcl-heading"><a class="standalone" href="/en/medicines/human/EPAR/cibinqo">Cibinqo</a></div><div class="metadata mb-3 me-n3"><div class="metadata-item text-muted me-3"><div class="metadata-field inn-common-name"> abrocitinib </div><div class="metadata-field med-therap-area"> Dermatitis, Atopic </div><div class="metadata-field medicine-icons d-flex flex-row flex-wrap gap-1"><div id="taxonomy-term-43273" class="taxonomy-term ema-string-replacement ema-string-replacement--ema-icon-mode" title="Additional monitoring"><svg class="bi icon--s" ><use xlink:href="/themes/custom/ema_theme/resources/icons/ema-icons/ema-default-icons.svg#icon-checkbox-arrow-down"/></svg></div></div></div><div class="metadata-item text-muted me-3"><div class="metadata-field date-authorisation"><strong class="label">Date of authorisation: </strong><time datetime="2021-12-09T12:00:00Z">9 December 2021</time></div><div class="metadata-field ema-revision-number"><strong class="label">Revision: </strong> 12 </div></div><div class="metadata-item text-muted me-3"><div class="metadata-field last-update"><strong class="label">Last updated:</strong> 17 February 2025 </div></div></div><div class="card-badge-wrapper d-flex flex-row flex-wrap gap-2-5 align-items-start mt-3"><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></article></div><div class="col"><article class="node ema-medicine search-index ema-medicine--search-index listing-item border-0 m-0 card text-dark"><div class='row'><div class='col-md-12 right-column'><div class="card-body p-0 pb-md-0 pb-3"><div class="teaser-title card-title bcl-heading"><a class="standalone" href="/en/medicines/human/EPAR/ulunar-breezhaler">Ulunar Breezhaler</a></div><div class="metadata mb-3 me-n3"><div class="metadata-item text-muted me-3"><div class="metadata-field inn-common-name"> indacaterol, glycopyrronium bromide </div><div class="metadata-field med-therap-area"> Pulmonary Disease, Chronic Obstructive </div></div><div class="metadata-item text-muted me-3"><div class="metadata-field date-authorisation"><strong class="label">Date of authorisation: </strong><time datetime="2014-04-23T12:00:00Z">23 April 2014</time></div><div class="metadata-field ema-revision-number"><strong class="label">Revision: </strong> 15 </div></div><div class="metadata-item text-muted me-3"><div class="metadata-field last-update"><strong class="label">Last updated:</strong> 17 February 2025 </div></div></div><div class="card-badge-wrapper d-flex flex-row flex-wrap gap-2-5 align-items-start mt-3"><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></article></div><div class="col"><article class="node ema-general search-index ema-general--search-index listing-item border-0 m-0 card text-dark"><div class='row'><div class='col-md-12 right-column'><div class="card-body p-0 pb-md-0 pb-3"><div class="teaser-title card-title bcl-heading"><a class="standalone" href="/en/partners-networks/international-activities/multilateral-coalitions-initiatives/international-coalition-medicines-regulatory-authorities-icmra"><span>International Coalition of Medicines Regulatory Authorities (ICMRA)</span></a></div><div class="card-text mb-3"><div class="field string-long ema-general__field-ema-summary"><p>The European Medicines Agency (EMA) is a member of the International Coalition of Medicines Regulatory Authorities (ICMRA). ICMRA is a voluntary, executive-level entity of worldwide medicines regulatory authorities set up to provide strategic coordination, advocacy and leadership.</p></div></div><div class="metadata mb-3 me-n3"><div class="metadata-item text-muted me-3"><div class="d-flex flex-row flex-wrap"><div class="metadata-field last-update"><strong class="label">Last updated:</strong> 17 February 2025 </div></div></div></div><div class="card-badge-wrapper d-flex flex-row flex-wrap gap-2-5 align-items-start mt-3"><span class="ema-bg-category badge rounded-pill badge-outline-primary" title="Human"><span class="label">Human</span></span><span class="ema-bg-topic special-topic badge rounded-pill bg-covid" title="COVID-19"><span class="label">COVID-19</span></span><span class="ema-bg-topic badge rounded-pill badge-outline-primary" title="Antimicrobial resistance"><span class="label">Antimicrobial resistance</span></span><span class="ema-bg-topic badge rounded-pill badge-outline-primary" title="Medicines"><span class="label">Medicines</span></span></div></div></div></div></article></div><div class="col"><article class="node ema-general search-index ema-general--search-index listing-item border-0 m-0 card text-dark"><div class='row'><div class='col-md-12 right-column'><div class="card-body p-0 pb-md-0 pb-3"><div class="teaser-title card-title bcl-heading"><a class="standalone" href="/en/about-us/how-we-work/big-data"><span>Big data</span></a></div><div class="card-text mb-3"><div class="field string-long ema-general__field-ema-summary"><p>Every day, vast amounts of data are generated that have the potential to inform and improve medicines regulation. In response, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) established a joint steering group to plan and prioritise actions that leverage big data to support innovation and public health in the European...</p></div></div><div class="metadata mb-3 me-n3"><div class="metadata-item text-muted me-3"><div class="d-flex flex-row flex-wrap"><div class="metadata-field last-update"><strong class="label">Last updated:</strong> 17 February 2025 </div></div></div></div><div class="card-badge-wrapper d-flex flex-row flex-wrap gap-2-5 align-items-start mt-3"><span class="ema-bg-category badge rounded-pill badge-outline-primary" title="Human"><span class="label">Human</span></span><span class="ema-bg-category badge rounded-pill badge-outline-primary" title="Veterinary"><span class="label">Veterinary</span></span><span class="ema-bg-category badge rounded-pill badge-outline-primary" title="Corporate"><span class="label">Corporate</span></span><span class="ema-bg-topic badge rounded-pill badge-outline-primary" title="Data on medicines"><span class="label">Data on medicines</span></span><span class="ema-bg-topic badge rounded-pill badge-outline-primary" title="Innovation"><span class="label">Innovation</span></span><span class="ema-bg-topic badge rounded-pill badge-outline-primary" title="Research and development"><span class="label">Research and development</span></span></div></div></div></div></article></div></div></div><hr class="d-none d-md-block mt-4-5"><nav class="pager" role="navigation" ><ul class="pagination pager__items js-pager__items justify-content-center"><li class="page-item pager__item active"><a aria-label="1" aria-current="page" class="page-link" href="?page=0">1</a></li><li class="page-item pager__item"><a aria-label="2" class="page-link" href="?page=1">2</a></li><li class="page-item pager__item"><a aria-label="3" class="page-link" href="?page=2">3</a></li><li class="page-item pager__item"><a aria-label="4" class="page-link" 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