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Regdanvimab - Wikipedia

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mw-list-item"><a href="https://de.wikipedia.org/wiki/Regdanvimab" title="Regdanvimab – German" lang="de" hreflang="de" data-title="Regdanvimab" data-language-autonym="Deutsch" data-language-local-name="German" class="interlanguage-link-target"><span>Deutsch</span></a></li><li class="interlanguage-link interwiki-el mw-list-item"><a href="https://el.wikipedia.org/wiki/%CE%A1%CE%B5%CE%B3%CE%BA%CE%BD%CF%84%CE%B1%CE%BD%CE%B2%CE%B9%CE%BC%CE%AC%CE%BC%CF%80%CE%B7" title="Ρεγκντανβιμάμπη – Greek" lang="el" hreflang="el" data-title="Ρεγκντανβιμάμπη" data-language-autonym="Ελληνικά" data-language-local-name="Greek" class="interlanguage-link-target"><span>Ελληνικά</span></a></li><li class="interlanguage-link interwiki-fr mw-list-item"><a href="https://fr.wikipedia.org/wiki/Regdanvimab" title="Regdanvimab – French" lang="fr" hreflang="fr" data-title="Regdanvimab" data-language-autonym="Français" data-language-local-name="French" class="interlanguage-link-target"><span>Français</span></a></li><li class="interlanguage-link interwiki-ko mw-list-item"><a href="https://ko.wikipedia.org/wiki/%EB%A0%88%EA%B7%B8%EB%8B%A8%EB%B9%84%EB%A7%99" title="레그단비맙 – Korean" lang="ko" hreflang="ko" data-title="레그단비맙" data-language-autonym="한국어" data-language-local-name="Korean" class="interlanguage-link-target"><span>한국어</span></a></li><li class="interlanguage-link interwiki-no mw-list-item"><a href="https://no.wikipedia.org/wiki/Regdanvimab" title="Regdanvimab – Norwegian Bokmål" lang="nb" hreflang="nb" data-title="Regdanvimab" data-language-autonym="Norsk bokmål" data-language-local-name="Norwegian Bokmål" class="interlanguage-link-target"><span>Norsk bokmål</span></a></li><li class="interlanguage-link interwiki-ru mw-list-item"><a href="https://ru.wikipedia.org/wiki/%D0%A0%D0%B5%D0%B3%D0%B4%D0%B0%D0%BD%D0%B2%D0%B8%D0%BC%D0%B0%D0%B1" title="Регданвимаб – Russian" lang="ru" hreflang="ru" data-title="Регданвимаб" data-language-autonym="Русский" data-language-local-name="Russian" class="interlanguage-link-target"><span>Русский</span></a></li><li class="interlanguage-link interwiki-sl mw-list-item"><a href="https://sl.wikipedia.org/wiki/Regdanvimab" title="Regdanvimab – Slovenian" lang="sl" hreflang="sl" data-title="Regdanvimab" data-language-autonym="Slovenščina" data-language-local-name="Slovenian" class="interlanguage-link-target"><span>Slovenščina</span></a></li><li class="interlanguage-link interwiki-uk mw-list-item"><a href="https://uk.wikipedia.org/wiki/%D0%A0%D0%B5%D0%B3%D0%B4%D0%B0%D0%BD%D0%B2%D1%96%D0%BC%D0%B0%D0%B1" title="Регданвімаб – Ukrainian" lang="uk" hreflang="uk" data-title="Регданвімаб" data-language-autonym="Українська" data-language-local-name="Ukrainian" class="interlanguage-link-target"><span>Українська</span></a></li><li class="interlanguage-link interwiki-zh mw-list-item"><a href="https://zh.wikipedia.org/wiki/%E7%91%9E%E4%B8%B9%E9%9F%A6%E5%8D%95%E6%8A%97" title="瑞丹韦单抗 – Chinese" lang="zh" hreflang="zh" data-title="瑞丹韦单抗" 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class="mw-body-content"><div class="mw-content-ltr mw-parser-output" lang="en" dir="ltr"><div class="shortdescription nomobile noexcerpt noprint searchaux" style="display:none">Monoclonal antibody</div> <p class="mw-empty-elt"> </p> <style data-mw-deduplicate="TemplateStyles:r1257001546">.mw-parser-output .infobox-subbox{padding:0;border:none;margin:-3px;width:auto;min-width:100%;font-size:100%;clear:none;float:none;background-color:transparent}.mw-parser-output .infobox-3cols-child{margin:auto}.mw-parser-output .infobox .navbar{font-size:100%}@media screen{html.skin-theme-clientpref-night .mw-parser-output .infobox-full-data:not(.notheme)>div:not(.notheme)[style]{background:#1f1f23!important;color:#f8f9fa}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .infobox-full-data:not(.notheme) div:not(.notheme){background:#1f1f23!important;color:#f8f9fa}}@media(min-width:640px){body.skin--responsive .mw-parser-output .infobox-table{display:table!important}body.skin--responsive .mw-parser-output .infobox-table>caption{display:table-caption!important}body.skin--responsive .mw-parser-output .infobox-table>tbody{display:table-row-group}body.skin--responsive .mw-parser-output .infobox-table tr{display:table-row!important}body.skin--responsive .mw-parser-output .infobox-table th,body.skin--responsive .mw-parser-output .infobox-table td{padding-left:inherit;padding-right:inherit}}</style><table class="infobox" style="border-spacing:2px;"><caption class="infobox-title"><span title="International nonproprietary name (INN): Regdanvimab">Regdanvimab</span></caption><tbody><tr><th colspan="2" class="infobox-header" style="background:#ddd"><a href="/wiki/Monoclonal_antibody" title="Monoclonal antibody">Monoclonal antibody</a></th></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/File:Engineered_monoclonal_antibodies.svg" title="File:Engineered monoclonal antibodies.svg">Type</a></th><td class="infobox-data">Whole antibody</td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Monoclonal_antibody#Production" title="Monoclonal antibody">Source</a></th><td class="infobox-data"><a href="/wiki/Human" title="Human">Human</a></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Antigen" title="Antigen">Target</a></th><td class="infobox-data"><a href="/wiki/Coronavirus_spike_protein" title="Coronavirus spike protein">Spike protein</a> of <a href="/wiki/Severe_acute_respiratory_syndrome_coronavirus_2" class="mw-redirect" title="Severe acute respiratory syndrome coronavirus 2">SARS-CoV-2</a></td></tr><tr><th colspan="2" class="infobox-header" style="background:#ddd">Clinical data</th></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Drug_nomenclature#Trade_names" title="Drug nomenclature">Trade names</a></th><td class="infobox-data">Regkirona</td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;">Other names</th><td class="infobox-data">CT-P59</td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Regulation_of_therapeutic_goods" title="Regulation of therapeutic goods">License data</a></th><td class="infobox-data"><style data-mw-deduplicate="TemplateStyles:r1126788409">.mw-parser-output .plainlist ol,.mw-parser-output .plainlist ul{line-height:inherit;list-style:none;margin:0;padding:0}.mw-parser-output .plainlist ol li,.mw-parser-output .plainlist ul li{margin-bottom:0}</style><div class="plainlist"> <ul><li><small><abbr class="country-name" title="European Union">EU</abbr></small>&#160;<a href="/wiki/European_Medicines_Agency" title="European Medicines Agency">EMA</a>:&#160;<span title="www.ema.europa.eu: &#39;Regdanvimab&#39;"><a rel="nofollow" class="external text" href="https://www.ema.europa.eu/en/medicines/search_api_aggregation_ema_active_substance_and_inn_common_name/Regdanvimab">by INN</a></span></li></ul></div> </td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Pregnancy_category" title="Pregnancy category">Pregnancy<br />category</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"> <ul><li><small><abbr class="country-name" title="Australia">AU</abbr>:</small>&#x20;B2<sup id="cite_ref-1" class="reference"><a href="#cite_note-1"><span class="cite-bracket">&#91;</span>1<span class="cite-bracket">&#93;</span></a></sup></li> <li class="mw-empty-elt"></li></ul> </div></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Route_of_administration" title="Route of administration">Routes of<br />administration</a></th><td class="infobox-data"><a href="/wiki/Intravenous_infusion" class="mw-redirect" title="Intravenous infusion">Intravenous</a></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Anatomical_Therapeutic_Chemical_Classification_System" title="Anatomical Therapeutic Chemical Classification System">ATC code</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><a href="/wiki/ATC_code_J06" title="ATC code J06">J06BD06</a>&#x20;(<span title="www.whocc.no"><a rel="nofollow" class="external text" href="https://www.whocc.no/atc_ddd_index/?code=J06BD06">WHO</a></span>)&#x20;</li></ul></div></td></tr><tr><th colspan="2" class="infobox-header" style="background:#ddd">Legal status</th></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Regulation_of_therapeutic_goods" title="Regulation of therapeutic goods">Legal status</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"> <ul><li><small><abbr class="country-name" title="Australia">AU</abbr>:</small>&#x20;<a href="/wiki/Standard_for_the_Uniform_Scheduling_of_Medicines_and_Poisons#Schedule_4" title="Standard for the Uniform Scheduling of Medicines and Poisons">S4</a> (Prescription only)<sup id="cite_ref-2" class="reference"><a href="#cite_note-2"><span class="cite-bracket">&#91;</span>2<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-3" class="reference"><a href="#cite_note-3"><span class="cite-bracket">&#91;</span>3<span class="cite-bracket">&#93;</span></a></sup></li> <li><small><abbr class="country-name" title="European Union">EU</abbr>:</small>&#x20;Rx-only<sup id="cite_ref-Regkirona_EPAR_4-0" class="reference"><a href="#cite_note-Regkirona_EPAR-4"><span class="cite-bracket">&#91;</span>4<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-EU_Regkirona_5-0" class="reference"><a href="#cite_note-EU_Regkirona-5"><span class="cite-bracket">&#91;</span>5<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-6" class="reference"><a href="#cite_note-6"><span class="cite-bracket">&#91;</span>6<span class="cite-bracket">&#93;</span></a></sup></li> <li>In&#160;general: ℞&#160;(Prescription only)</li></ul></div> </td></tr><tr><th colspan="2" class="infobox-header" style="background:#ddd">Identifiers</th></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/CAS_Registry_Number" title="CAS Registry Number">CAS Number</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><span title="commonchemistry.cas.org"><a rel="nofollow" class="external text" href="https://commonchemistry.cas.org/detail?cas_rn=2444308-95-4">2444308-95-4</a></span></li></ul></div></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/DrugBank" title="DrugBank">DrugBank</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><span title="www.drugbank.ca"><a rel="nofollow" class="external text" href="https://www.drugbank.ca/drugs/DB16405">DB16405</a></span></li></ul></div></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Unique_Ingredient_Identifier" title="Unique Ingredient Identifier">UNII</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><span title="precision.fda.gov"><a rel="nofollow" class="external text" href="https://precision.fda.gov/uniisearch/srs/unii/I0BGE6P6I6">I0BGE6P6I6</a></span></li></ul></div></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/KEGG" title="KEGG">KEGG</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><span title="www.kegg.jp"><a rel="nofollow" class="external text" href="https://www.kegg.jp/entry/D12241">D12241</a></span></li></ul></div></td></tr></tbody></table> <p><b>Regdanvimab</b>, sold under the brand name <b>Regkirona</b>, is a <a href="/wiki/Human_monoclonal_antibody" class="mw-redirect" title="Human monoclonal antibody">human monoclonal antibody</a> used for the treatment of <a href="/wiki/COVID-19" title="COVID-19">COVID-19</a>.<sup id="cite_ref-Regkirona_EPAR_4-1" class="reference"><a href="#cite_note-Regkirona_EPAR-4"><span class="cite-bracket">&#91;</span>4<span class="cite-bracket">&#93;</span></a></sup> The antibody is directed against the <a href="/wiki/Coronavirus_spike_protein" title="Coronavirus spike protein">spike protein</a> of <a href="/wiki/SARS-CoV-2" title="SARS-CoV-2">SARS-CoV-2</a>. It is developed by <a href="/wiki/Celltrion" title="Celltrion">Celltrion</a>.<sup id="cite_ref-7" class="reference"><a href="#cite_note-7"><span class="cite-bracket">&#91;</span>7<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-8" class="reference"><a href="#cite_note-8"><span class="cite-bracket">&#91;</span>8<span class="cite-bracket">&#93;</span></a></sup> The medicine is given by infusion (drip) into a vein.<sup id="cite_ref-Regkirona_EPAR_4-2" class="reference"><a href="#cite_note-Regkirona_EPAR-4"><span class="cite-bracket">&#91;</span>4<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-EU_regdanvimab_9-0" class="reference"><a href="#cite_note-EU_regdanvimab-9"><span class="cite-bracket">&#91;</span>9<span class="cite-bracket">&#93;</span></a></sup> </p><p>The most common side effects include infusion-related reactions, including allergic reactions and anaphylaxis.<sup id="cite_ref-Regkirona_EPAR_4-3" class="reference"><a href="#cite_note-Regkirona_EPAR-4"><span class="cite-bracket">&#91;</span>4<span class="cite-bracket">&#93;</span></a></sup> </p><p>Regdanvimab was approved for medical use in the European Union in November 2021.<sup id="cite_ref-Regkirona_EPAR_4-4" class="reference"><a href="#cite_note-Regkirona_EPAR-4"><span class="cite-bracket">&#91;</span>4<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-EU_Regkirona_5-1" class="reference"><a href="#cite_note-EU_Regkirona-5"><span class="cite-bracket">&#91;</span>5<span class="cite-bracket">&#93;</span></a></sup> </p> <meta property="mw:PageProp/toc" /> <div class="mw-heading mw-heading2"><h2 id="Medical_uses">Medical uses</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regdanvimab&amp;action=edit&amp;section=1" title="Edit section: Medical uses"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In the European Union, regdanvimab is <a href="/wiki/Indication_(medicine)" title="Indication (medicine)">indicated</a> for the treatment of adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.<sup id="cite_ref-Regkirona_EPAR_4-5" class="reference"><a href="#cite_note-Regkirona_EPAR-4"><span class="cite-bracket">&#91;</span>4<span class="cite-bracket">&#93;</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Society_and_culture">Society and culture</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regdanvimab&amp;action=edit&amp;section=2" title="Edit section: Society and culture"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <div class="mw-heading mw-heading3"><h3 id="Legal_status">Legal status</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regdanvimab&amp;action=edit&amp;section=3" title="Edit section: Legal status"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>In March 2021, the <a href="/wiki/Committee_for_Medicinal_Products_for_Human_Use" title="Committee for Medicinal Products for Human Use">Committee for Medicinal Products for Human Use</a> (CHMP) of the <a href="/wiki/European_Medicines_Agency" title="European Medicines Agency">European Medicines Agency</a> (EMA) started a rolling review of data on regdanvimab.<sup id="cite_ref-Regdanvimab_rolling_review_10-0" class="reference"><a href="#cite_note-Regdanvimab_rolling_review-10"><span class="cite-bracket">&#91;</span>10<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-11" class="reference"><a href="#cite_note-11"><span class="cite-bracket">&#91;</span>11<span class="cite-bracket">&#93;</span></a></sup> In October 2021, the EMA started evaluating an application for marketing authorization for the monoclonal antibody regdanvimab (Regkirona) to treat adults with COVID-19 who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID-19.<sup id="cite_ref-EU_Regkirona_application_12-0" class="reference"><a href="#cite_note-EU_Regkirona_application-12"><span class="cite-bracket">&#91;</span>12<span class="cite-bracket">&#93;</span></a></sup> The applicant is Celltrion Healthcare Hungary Kft.<sup id="cite_ref-EU_Regkirona_application_12-1" class="reference"><a href="#cite_note-EU_Regkirona_application-12"><span class="cite-bracket">&#91;</span>12<span class="cite-bracket">&#93;</span></a></sup> The <a href="/wiki/European_Medicines_Agency" title="European Medicines Agency">European Medicines Agency</a> (EMA) concluded that regdanvimab can be used for the treatment of confirmed COVID-19 in adults who do not require supplemental oxygen therapy and who are at high risk of progressing to severe COVID-19.<sup id="cite_ref-EU_regdanvimab_9-1" class="reference"><a href="#cite_note-EU_regdanvimab-9"><span class="cite-bracket">&#91;</span>9<span class="cite-bracket">&#93;</span></a></sup> </p><p>In November 2021, the <a href="/wiki/Committee_for_Medicinal_Products_for_Human_Use" title="Committee for Medicinal Products for Human Use">Committee for Medicinal Products for Human Use</a> (CHMP) of the <a href="/wiki/European_Medicines_Agency" title="European Medicines Agency">European Medicines Agency</a> (EMA) recommended granting a marketing authorization in the European Union for regdanvimab (Regkirona) for the treatment of COVID-19.<sup id="cite_ref-Regkirona:_Pending_EC_decision_13-0" class="reference"><a href="#cite_note-Regkirona:_Pending_EC_decision-13"><span class="cite-bracket">&#91;</span>13<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-EMA_Regkirona_14-0" class="reference"><a href="#cite_note-EMA_Regkirona-14"><span class="cite-bracket">&#91;</span>14<span class="cite-bracket">&#93;</span></a></sup> The company that applied for authorization of Regkirona is Celltrion Healthcare Hungary Kft.<sup id="cite_ref-EMA_Regkirona_14-1" class="reference"><a href="#cite_note-EMA_Regkirona-14"><span class="cite-bracket">&#91;</span>14<span class="cite-bracket">&#93;</span></a></sup> Regdanvimab was approved for medical use in the European Union in November 2021.<sup id="cite_ref-Regkirona_EPAR_4-6" class="reference"><a href="#cite_note-Regkirona_EPAR-4"><span class="cite-bracket">&#91;</span>4<span class="cite-bracket">&#93;</span></a></sup><sup id="cite_ref-EU_Regkirona_5-2" class="reference"><a href="#cite_note-EU_Regkirona-5"><span class="cite-bracket">&#91;</span>5<span class="cite-bracket">&#93;</span></a></sup> </p> <div class="mw-heading mw-heading3"><h3 id="Names">Names</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regdanvimab&amp;action=edit&amp;section=4" title="Edit section: Names"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Regdanvimab is the <a href="/wiki/International_nonproprietary_name" title="International nonproprietary name">international nonproprietary name</a> (INN).<sup id="cite_ref-INN_15-0" class="reference"><a href="#cite_note-INN-15"><span class="cite-bracket">&#91;</span>15<span class="cite-bracket">&#93;</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="References">References</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regdanvimab&amp;action=edit&amp;section=5" title="Edit section: References"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1239543626">.mw-parser-output .reflist{margin-bottom:0.5em;list-style-type:decimal}@media screen{.mw-parser-output .reflist{font-size:90%}}.mw-parser-output .reflist .references{font-size:100%;margin-bottom:0;list-style-type:inherit}.mw-parser-output .reflist-columns-2{column-width:30em}.mw-parser-output .reflist-columns-3{column-width:25em}.mw-parser-output .reflist-columns{margin-top:0.3em}.mw-parser-output .reflist-columns ol{margin-top:0}.mw-parser-output .reflist-columns li{page-break-inside:avoid;break-inside:avoid-column}.mw-parser-output .reflist-upper-alpha{list-style-type:upper-alpha}.mw-parser-output .reflist-upper-roman{list-style-type:upper-roman}.mw-parser-output .reflist-lower-alpha{list-style-type:lower-alpha}.mw-parser-output .reflist-lower-greek{list-style-type:lower-greek}.mw-parser-output .reflist-lower-roman{list-style-type:lower-roman}</style><div class="reflist"> <div class="mw-references-wrap mw-references-columns"><ol class="references"> <li id="cite_note-1"><span class="mw-cite-backlink"><b><a href="#cite_ref-1">^</a></b></span> <span class="reference-text"><style data-mw-deduplicate="TemplateStyles:r1238218222">.mw-parser-output cite.citation{font-style:inherit;word-wrap:break-word}.mw-parser-output .citation q{quotes:"\"""\"""'""'"}.mw-parser-output .citation:target{background-color:rgba(0,127,255,0.133)}.mw-parser-output .id-lock-free.id-lock-free a{background:url("//upload.wikimedia.org/wikipedia/commons/6/65/Lock-green.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-limited.id-lock-limited a,.mw-parser-output .id-lock-registration.id-lock-registration a{background:url("//upload.wikimedia.org/wikipedia/commons/d/d6/Lock-gray-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-subscription.id-lock-subscription a{background:url("//upload.wikimedia.org/wikipedia/commons/a/aa/Lock-red-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .cs1-ws-icon a{background:url("//upload.wikimedia.org/wikipedia/commons/4/4c/Wikisource-logo.svg")right 0.1em center/12px no-repeat}body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-free a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-limited a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-registration a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-subscription a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .cs1-ws-icon a{background-size:contain;padding:0 1em 0 0}.mw-parser-output .cs1-code{color:inherit;background:inherit;border:none;padding:inherit}.mw-parser-output .cs1-hidden-error{display:none;color:var(--color-error,#d33)}.mw-parser-output .cs1-visible-error{color:var(--color-error,#d33)}.mw-parser-output .cs1-maint{display:none;color:#085;margin-left:0.3em}.mw-parser-output .cs1-kern-left{padding-left:0.2em}.mw-parser-output .cs1-kern-right{padding-right:0.2em}.mw-parser-output .citation .mw-selflink{font-weight:inherit}@media screen{.mw-parser-output .cs1-format{font-size:95%}html.skin-theme-clientpref-night .mw-parser-output .cs1-maint{color:#18911f}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .cs1-maint{color:#18911f}}</style><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.tga.gov.au/resources/resource/guidance/updates-prescribing-medicines-pregnancy-database">"Updates to the Prescribing Medicines in Pregnancy database"</a>. <i>Therapeutic Goods Administration (TGA)</i>. 12 May 2022. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20220403064059/https://www.tga.gov.au/updates-prescribing-medicines-pregnancy-database">Archived</a> from the original on 3 April 2022<span class="reference-accessdate">. Retrieved <span class="nowrap">13 May</span> 2022</span>.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&amp;rft.genre=unknown&amp;rft.jtitle=Therapeutic+Goods+Administration+%28TGA%29&amp;rft.atitle=Updates+to+the+Prescribing+Medicines+in+Pregnancy+database&amp;rft.date=2022-05-12&amp;rft_id=https%3A%2F%2Fwww.tga.gov.au%2Fresources%2Fresource%2Fguidance%2Fupdates-prescribing-medicines-pregnancy-database&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ARegdanvimab" class="Z3988"></span></span> </li> <li id="cite_note-2"><span class="mw-cite-backlink"><b><a href="#cite_ref-2">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.tga.gov.au/auspar/auspar-regdanvimab">"AusPAR: Regdanvimab"</a>. <i>Therapeutic Goods Administration (TGA)</i>. 7 December 2021. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20220105051231/https://www.tga.gov.au/auspar/auspar-regdanvimab">Archived</a> from the original on 5 January 2022<span class="reference-accessdate">. Retrieved <span class="nowrap">4 January</span> 2022</span>.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&amp;rft.genre=unknown&amp;rft.jtitle=Therapeutic+Goods+Administration+%28TGA%29&amp;rft.atitle=AusPAR%3A+Regdanvimab&amp;rft.date=2021-12-07&amp;rft_id=https%3A%2F%2Fwww.tga.gov.au%2Fauspar%2Fauspar-regdanvimab&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ARegdanvimab" class="Z3988"></span></span> </li> <li id="cite_note-3"><span class="mw-cite-backlink"><b><a href="#cite_ref-3">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation pressrelease cs1"><a rel="nofollow" class="external text" href="https://www.tga.gov.au/media-release/tga-provisional-approval-celltrion-healthcare-australia-pty-ltd-covid-19-treatment-regdanvimab-regkirona">"TGA Provisional Approval of Celltrion Healthcare Australia Pty Ltd COVID-19 treatment, regdanvimab (Regkirona)"</a>. <i>Therapeutic Goods Administration (TGA)</i> (Press release). 6 December 2021. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20220105051410/https://www.tga.gov.au/media-release/tga-provisional-approval-celltrion-healthcare-australia-pty-ltd-covid-19-treatment-regdanvimab-regkirona">Archived</a> from the original on 5 January 2022<span class="reference-accessdate">. Retrieved <span class="nowrap">4 January</span> 2022</span>.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&amp;rft.genre=unknown&amp;rft.btitle=TGA+Provisional+Approval+of+Celltrion+Healthcare+Australia+Pty+Ltd+COVID-19+treatment%2C+regdanvimab+%28Regkirona%29&amp;rft.date=2021-12-06&amp;rft_id=https%3A%2F%2Fwww.tga.gov.au%2Fmedia-release%2Ftga-provisional-approval-celltrion-healthcare-australia-pty-ltd-covid-19-treatment-regdanvimab-regkirona&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ARegdanvimab" class="Z3988"></span></span> </li> <li id="cite_note-Regkirona_EPAR-4"><span class="mw-cite-backlink">^ <a href="#cite_ref-Regkirona_EPAR_4-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-Regkirona_EPAR_4-1"><sup><i><b>b</b></i></sup></a> <a href="#cite_ref-Regkirona_EPAR_4-2"><sup><i><b>c</b></i></sup></a> <a href="#cite_ref-Regkirona_EPAR_4-3"><sup><i><b>d</b></i></sup></a> <a href="#cite_ref-Regkirona_EPAR_4-4"><sup><i><b>e</b></i></sup></a> <a href="#cite_ref-Regkirona_EPAR_4-5"><sup><i><b>f</b></i></sup></a> <a href="#cite_ref-Regkirona_EPAR_4-6"><sup><i><b>g</b></i></sup></a></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.ema.europa.eu/en/medicines/human/EPAR/regkirona">"Regkirona EPAR"</a>. <i>European Medicines Agency</i>. 10 November 2021. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20211112234216/https://www.ema.europa.eu/en/medicines/human/EPAR/regkirona">Archived</a> from the original on 12 November 2021<span class="reference-accessdate">. Retrieved <span class="nowrap">12 November</span> 2021</span>.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&amp;rft.genre=unknown&amp;rft.jtitle=European+Medicines+Agency&amp;rft.atitle=Regkirona+EPAR&amp;rft.date=2021-11-10&amp;rft_id=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fmedicines%2Fhuman%2FEPAR%2Fregkirona&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ARegdanvimab" class="Z3988"></span> Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</span> </li> <li id="cite_note-EU_Regkirona-5"><span class="mw-cite-backlink">^ <a href="#cite_ref-EU_Regkirona_5-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-EU_Regkirona_5-1"><sup><i><b>b</b></i></sup></a> <a href="#cite_ref-EU_Regkirona_5-2"><sup><i><b>c</b></i></sup></a></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://ec.europa.eu/health/documents/community-register/html/h1597.htm">"Regkirona"</a>. <i>Union Register of medicinal products</i>. 12 November 2021. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20220424220714/https://ec.europa.eu/health/documents/community-register/html/h1597.htm">Archived</a> from the original on 24 April 2022<span class="reference-accessdate">. Retrieved <span class="nowrap">24 April</span> 2022</span>.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&amp;rft.genre=unknown&amp;rft.jtitle=Union+Register+of+medicinal+products&amp;rft.atitle=Regkirona&amp;rft.date=2021-11-12&amp;rft_id=https%3A%2F%2Fec.europa.eu%2Fhealth%2Fdocuments%2Fcommunity-register%2Fhtml%2Fh1597.htm&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ARegdanvimab" class="Z3988"></span></span> </li> <li id="cite_note-6"><span class="mw-cite-backlink"><b><a href="#cite_ref-6">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines">"COVID-19 medicines"</a>. <i>European Medicines Agency (EMA)</i>. 14 October 2024<span class="reference-accessdate">. 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Celltrion. 11 February 2021. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20211019085926/https://www.businesswire.com/news/home/20210210006036/en/Celltrion-Develops-Tailored-Neutralising-Antibody-Cocktail-Treatment-with-CT-P59-to-Tackle-COVID-19-Variant-Spread-Using-Its-Antibody-Development-Platform">Archived</a> from the original on 19 October 2021<span class="reference-accessdate">. Retrieved <span class="nowrap">4 March</span> 2021</span> &#8211; via Business Wire.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&amp;rft.genre=unknown&amp;rft.btitle=Celltrion+Develops+Tailored+Neutralising+Antibody+Cocktail+Treatment+with+CT-P59+to+Tackle+COVID-19+Variant+Spread+Using+Its+Antibody+Development+Platform&amp;rft.pub=Celltrion&amp;rft.date=2021-02-11&amp;rft_id=https%3A%2F%2Fwww.businesswire.com%2Fnews%2Fhome%2F20210210006036%2Fen%2FCelltrion-Develops-Tailored-Neutralising-Antibody-Cocktail-Treatment-with-CT-P59-to-Tackle-COVID-19-Variant-Spread-Using-Its-Antibody-Development-Platform&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ARegdanvimab" class="Z3988"></span></span> </li> <li id="cite_note-8"><span class="mw-cite-backlink"><b><a href="#cite_ref-8">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation pressrelease cs1"><a rel="nofollow" class="external text" href="https://www.businesswire.com/news/home/20210113005355/en/Celltrion-Group-announces-positive-top-line-efficacy-and-safety-data-from-global-Phase-IIIII-clinical-trial-of-COVID-19-treatment-candidate-CT-P59">"Celltrion Group announces positive top-line efficacy and safety data from global Phase II/III clinical trial of COVID-19 treatment candidate CT-P59"</a> (Press release). Celltrion. 13 January 2021. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20211019233631/https://www.businesswire.com/news/home/20210113005355/en/Celltrion-Group-announces-positive-top-line-efficacy-and-safety-data-from-global-Phase-IIIII-clinical-trial-of-COVID-19-treatment-candidate-CT-P59">Archived</a> from the original on 19 October 2021<span class="reference-accessdate">. Retrieved <span class="nowrap">4 March</span> 2021</span> &#8211; via Business Wire.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&amp;rft.genre=unknown&amp;rft.btitle=Celltrion+Group+announces+positive+top-line+efficacy+and+safety+data+from+global+Phase+II%2FIII+clinical+trial+of+COVID-19+treatment+candidate+CT-P59&amp;rft.pub=Celltrion&amp;rft.date=2021-01-13&amp;rft_id=https%3A%2F%2Fwww.businesswire.com%2Fnews%2Fhome%2F20210113005355%2Fen%2FCelltrion-Group-announces-positive-top-line-efficacy-and-safety-data-from-global-Phase-IIIII-clinical-trial-of-COVID-19-treatment-candidate-CT-P59&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ARegdanvimab" class="Z3988"></span></span> </li> <li id="cite_note-EU_regdanvimab-9"><span class="mw-cite-backlink">^ <a href="#cite_ref-EU_regdanvimab_9-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-EU_regdanvimab_9-1"><sup><i><b>b</b></i></sup></a></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.ema.europa.eu/en/news/ema-issues-advice-use-regdanvimab-treating-covid-19">"EMA issues advice on use of regdanvimab for treating COVID-19"</a>. <i>European Medicines Agency</i>. 26 March 2021. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20211115162651/https://www.ema.europa.eu/en/news/ema-issues-advice-use-regdanvimab-treating-covid-19">Archived</a> from the original on 15 November 2021<span class="reference-accessdate">. Retrieved <span class="nowrap">15 October</span> 2021</span>.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&amp;rft.genre=unknown&amp;rft.jtitle=European+Medicines+Agency&amp;rft.atitle=EMA+issues+advice+on+use+of+regdanvimab+for+treating+COVID-19&amp;rft.date=2021-03-26&amp;rft_id=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fnews%2Fema-issues-advice-use-regdanvimab-treating-covid-19&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ARegdanvimab" class="Z3988"></span></span> </li> <li id="cite_note-Regdanvimab_rolling_review-10"><span class="mw-cite-backlink"><b><a href="#cite_ref-Regdanvimab_rolling_review_10-0">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation pressrelease cs1"><a rel="nofollow" class="external text" href="https://www.ema.europa.eu/en/news/ema-starts-rolling-review-celltrion-antibody-regdanvimab-covid-19">"EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19"</a> (Press release). <a href="/wiki/European_Medicines_Agency" title="European Medicines Agency">European Medicines Agency</a> (EMA). 24 February 2021. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20211115121425/https://www.ema.europa.eu/en/news/ema-starts-rolling-review-celltrion-antibody-regdanvimab-covid-19">Archived</a> from the original on 15 November 2021<span class="reference-accessdate">. Retrieved <span class="nowrap">4 March</span> 2021</span>.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&amp;rft.genre=unknown&amp;rft.btitle=EMA+starts+rolling+review+of+Celltrion+antibody+regdanvimab+for+COVID-19&amp;rft.pub=European+Medicines+Agency+%28EMA%29&amp;rft.date=2021-02-24&amp;rft_id=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fnews%2Fema-starts-rolling-review-celltrion-antibody-regdanvimab-covid-19&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ARegdanvimab" class="Z3988"></span></span> </li> <li id="cite_note-11"><span class="mw-cite-backlink"><b><a href="#cite_ref-11">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation pressrelease cs1"><a rel="nofollow" class="external text" href="https://www.ema.europa.eu/en/news/ema-review-regdanvimab-covid-19-support-national-decisions-early-use">"EMA review of regdanvimab for COVID-19 to support national decisions on early use"</a> (Press release). <a href="/wiki/European_Medicines_Agency" title="European Medicines Agency">European Medicines Agency</a> (EMA). 2 March 2021. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20211028165451/https://www.ema.europa.eu/en/news/ema-review-regdanvimab-covid-19-support-national-decisions-early-use">Archived</a> from the original on 28 October 2021<span class="reference-accessdate">. Retrieved <span class="nowrap">4 March</span> 2021</span>.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&amp;rft.genre=unknown&amp;rft.btitle=EMA+review+of+regdanvimab+for+COVID-19+to+support+national+decisions+on+early+use&amp;rft.pub=European+Medicines+Agency+%28EMA%29&amp;rft.date=2021-03-02&amp;rft_id=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fnews%2Fema-review-regdanvimab-covid-19-support-national-decisions-early-use&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ARegdanvimab" class="Z3988"></span></span> </li> <li id="cite_note-EU_Regkirona_application-12"><span class="mw-cite-backlink">^ <a href="#cite_ref-EU_Regkirona_application_12-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-EU_Regkirona_application_12-1"><sup><i><b>b</b></i></sup></a></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.ema.europa.eu/en/news/ema-receives-application-marketing-authorisation-regkirona-regdanvimab-treating-patients-covid-19">"EMA receives application for marketing authorisation Regkirona (regdanvimab) treating patients with COVID-19"</a>. <i>European Medicines Agency</i>. 4 October 2021. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20211111223800/https://www.ema.europa.eu/en/news/ema-receives-application-marketing-authorisation-regkirona-regdanvimab-treating-patients-covid-19">Archived</a> from the original on 11 November 2021<span class="reference-accessdate">. Retrieved <span class="nowrap">15 October</span> 2021</span>.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&amp;rft.genre=unknown&amp;rft.jtitle=European+Medicines+Agency&amp;rft.atitle=EMA+receives+application+for+marketing+authorisation+Regkirona+%28regdanvimab%29+treating+patients+with+COVID-19&amp;rft.date=2021-10-04&amp;rft_id=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fnews%2Fema-receives-application-marketing-authorisation-regkirona-regdanvimab-treating-patients-covid-19&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ARegdanvimab" class="Z3988"></span></span> </li> <li id="cite_note-Regkirona:_Pending_EC_decision-13"><span class="mw-cite-backlink"><b><a href="#cite_ref-Regkirona:_Pending_EC_decision_13-0">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.ema.europa.eu/en/medicines/human/summaries-opinion/regkirona">"Regkirona: Pending EC decision"</a>. <i>European Medicines Agency</i>. 11 November 2021. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20211111160438/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/regkirona">Archived</a> from the original on 11 November 2021<span class="reference-accessdate">. Retrieved <span class="nowrap">11 November</span> 2021</span>.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&amp;rft.genre=unknown&amp;rft.jtitle=European+Medicines+Agency&amp;rft.atitle=Regkirona%3A+Pending+EC+decision&amp;rft.date=2021-11-11&amp;rft_id=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fmedicines%2Fhuman%2Fsummaries-opinion%2Fregkirona&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ARegdanvimab" class="Z3988"></span></span> </li> <li id="cite_note-EMA_Regkirona-14"><span class="mw-cite-backlink">^ <a href="#cite_ref-EMA_Regkirona_14-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-EMA_Regkirona_14-1"><sup><i><b>b</b></i></sup></a></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation pressrelease cs1"><a rel="nofollow" class="external text" href="https://www.ema.europa.eu/en/news/covid-19-ema-recommends-authorisation-two-monoclonal-antibody-medicines">"COVID-19: EMA recommends authorisation of two monoclonal antibody medicines"</a>. <i><a href="/wiki/European_Medicines_Agency" title="European Medicines Agency">European Medicines Agency</a> (EMA)</i> (Press release). 11 November 2021. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20211113183516/https://www.ema.europa.eu/en/news/covid-19-ema-recommends-authorisation-two-monoclonal-antibody-medicines">Archived</a> from the original on 13 November 2021<span class="reference-accessdate">. Retrieved <span class="nowrap">11 November</span> 2021</span>.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&amp;rft.genre=unknown&amp;rft.btitle=COVID-19%3A+EMA+recommends+authorisation+of+two+monoclonal+antibody+medicines&amp;rft.date=2021-11-11&amp;rft_id=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fnews%2Fcovid-19-ema-recommends-authorisation-two-monoclonal-antibody-medicines&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ARegdanvimab" class="Z3988"></span></span> </li> <li id="cite_note-INN-15"><span class="mw-cite-backlink"><b><a href="#cite_ref-INN_15-0">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFWorld_Health_Organization2021" class="citation journal cs1"><a href="/wiki/World_Health_Organization" title="World Health Organization">World Health Organization</a> (2021). <a rel="nofollow" class="external text" href="https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-(inn)/rl85.pdf">"International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85"</a> <span class="cs1-format">(PDF)</span>. <i>WHO Drug Information</i>. <b>35</b> (1). <a rel="nofollow" class="external text" href="https://web.archive.org/web/20210419172602/https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-%28inn%29/rl85.pdf">Archived</a> <span class="cs1-format">(PDF)</span> from the original on 19 April 2021<span class="reference-accessdate">. Retrieved <span class="nowrap">24 April</span> 2022</span>.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&amp;rft.genre=article&amp;rft.jtitle=WHO+Drug+Information&amp;rft.atitle=International+nonproprietary+names+for+pharmaceutical+substances+%28INN%29%3A+recommended+INN%3A+list+85&amp;rft.volume=35&amp;rft.issue=1&amp;rft.date=2021&amp;rft.au=World+Health+Organization&amp;rft_id=https%3A%2F%2Fcdn.who.int%2Fmedia%2Fdocs%2Fdefault-source%2Finternational-nonproprietary-names-%28inn%29%2Frl85.pdf&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ARegdanvimab" class="Z3988"></span></span> </li> </ol></div></div> <div class="mw-heading mw-heading2"><h2 id="Further_reading">Further reading</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regdanvimab&amp;action=edit&amp;section=6" title="Edit section: Further reading"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFKimRyuLeeKim2021" class="citation journal cs1">Kim C, Ryu DK, Lee J, Kim YI, Seo JM, Kim YG, et&#160;al. (January 2021). <a rel="nofollow" class="external text" href="https://doi.org/10.1038%2Fs41467-020-20602-5">"A therapeutic neutralizing antibody targeting receptor binding domain of SARS-CoV-2 spike protein"</a>. <i>Nature Communications</i>. <b>12</b> (1): 288. <a href="/wiki/Doi_(identifier)" class="mw-redirect" title="Doi (identifier)">doi</a>:<span class="id-lock-free" title="Freely accessible"><a rel="nofollow" class="external text" href="https://doi.org/10.1038%2Fs41467-020-20602-5">10.1038/s41467-020-20602-5</a></span>. <a href="/wiki/PMC_(identifier)" class="mw-redirect" title="PMC (identifier)">PMC</a>&#160;<span class="id-lock-free" title="Freely accessible"><a rel="nofollow" class="external text" href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7803729">7803729</a></span>. <a href="/wiki/PMID_(identifier)" class="mw-redirect" title="PMID (identifier)">PMID</a>&#160;<a rel="nofollow" class="external text" href="https://pubmed.ncbi.nlm.nih.gov/33436577">33436577</a>.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&amp;rft.genre=article&amp;rft.jtitle=Nature+Communications&amp;rft.atitle=A+therapeutic+neutralizing+antibody+targeting+receptor+binding+domain+of+SARS-CoV-2+spike+protein&amp;rft.volume=12&amp;rft.issue=1&amp;rft.pages=288&amp;rft.date=2021-01&amp;rft_id=https%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC7803729%23id-name%3DPMC&amp;rft_id=info%3Apmid%2F33436577&amp;rft_id=info%3Adoi%2F10.1038%2Fs41467-020-20602-5&amp;rft.aulast=Kim&amp;rft.aufirst=C&amp;rft.au=Ryu%2C+DK&amp;rft.au=Lee%2C+J&amp;rft.au=Kim%2C+YI&amp;rft.au=Seo%2C+JM&amp;rft.au=Kim%2C+YG&amp;rft.au=Jeong%2C+JH&amp;rft.au=Kim%2C+M&amp;rft.au=Kim%2C+JI&amp;rft.au=Kim%2C+P&amp;rft.au=Bae%2C+JS&amp;rft.au=Shim%2C+EY&amp;rft.au=Lee%2C+MS&amp;rft.au=Kim%2C+MS&amp;rft.au=Noh%2C+H&amp;rft.au=Park%2C+GS&amp;rft.au=Park%2C+JS&amp;rft.au=Son%2C+D&amp;rft.au=An%2C+Y&amp;rft.au=Lee%2C+JN&amp;rft.au=Kwon%2C+KS&amp;rft.au=Lee%2C+JY&amp;rft.au=Lee%2C+H&amp;rft.au=Yang%2C+JS&amp;rft.au=Kim%2C+KC&amp;rft.au=Kim%2C+SS&amp;rft.au=Woo%2C+HM&amp;rft.au=Kim%2C+JW&amp;rft.au=Park%2C+MS&amp;rft.au=Yu%2C+KM&amp;rft.au=Kim%2C+SM&amp;rft.au=Kim%2C+EH&amp;rft.au=Park%2C+SJ&amp;rft.au=Jeong%2C+ST&amp;rft.au=Yu%2C+CH&amp;rft.au=Song%2C+Y&amp;rft.au=Gu%2C+SH&amp;rft.au=Oh%2C+H&amp;rft.au=Koo%2C+BS&amp;rft.au=Hong%2C+JJ&amp;rft.au=Ryu%2C+CM&amp;rft.au=Park%2C+WB&amp;rft.au=Oh%2C+MD&amp;rft.au=Choi%2C+YK&amp;rft.au=Lee%2C+SY&amp;rft_id=https%3A%2F%2Fdoi.org%2F10.1038%252Fs41467-020-20602-5&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ARegdanvimab" class="Z3988"></span></li> <li><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFSyed2021" class="citation journal cs1">Syed YY (December 2021). <a rel="nofollow" class="external text" href="https://doi.org/10.1007%2Fs40265-021-01626-7">"Regdanvimab: First Approval"</a>. <i>Drugs</i>. <b>81</b> (18): 2133–7. <a href="/wiki/Doi_(identifier)" class="mw-redirect" title="Doi (identifier)">doi</a>:<span class="id-lock-free" title="Freely accessible"><a rel="nofollow" class="external text" href="https://doi.org/10.1007%2Fs40265-021-01626-7">10.1007/s40265-021-01626-7</a></span>. <a href="/wiki/PMC_(identifier)" class="mw-redirect" title="PMC (identifier)">PMC</a>&#160;<span class="id-lock-free" title="Freely accessible"><a rel="nofollow" class="external text" href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8558754">8558754</a></span>. <a href="/wiki/PMID_(identifier)" class="mw-redirect" title="PMID (identifier)">PMID</a>&#160;<a rel="nofollow" class="external text" href="https://pubmed.ncbi.nlm.nih.gov/34724174">34724174</a>.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&amp;rft.genre=article&amp;rft.jtitle=Drugs&amp;rft.atitle=Regdanvimab%3A+First+Approval&amp;rft.volume=81&amp;rft.issue=18&amp;rft.pages=2133-7&amp;rft.date=2021-12&amp;rft_id=https%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpmc%2Farticles%2FPMC8558754%23id-name%3DPMC&amp;rft_id=info%3Apmid%2F34724174&amp;rft_id=info%3Adoi%2F10.1007%2Fs40265-021-01626-7&amp;rft.aulast=Syed&amp;rft.aufirst=YY&amp;rft_id=https%3A%2F%2Fdoi.org%2F10.1007%252Fs40265-021-01626-7&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ARegdanvimab" class="Z3988"></span></li></ul> <div class="mw-heading mw-heading2"><h2 id="External_links">External links</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Regdanvimab&amp;action=edit&amp;section=7" title="Edit section: External links"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://druginfo.nlm.nih.gov/drugportal/name/regdanvimab">"Regdanvimab"</a>. <i>Drug Information Portal</i>. U.S. National Library of Medicine.</cite><span title="ctx_ver=Z39.88-2004&amp;rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&amp;rft.genre=unknown&amp;rft.jtitle=Drug+Information+Portal&amp;rft.atitle=Regdanvimab&amp;rft_id=https%3A%2F%2Fdruginfo.nlm.nih.gov%2Fdrugportal%2Fname%2Fregdanvimab&amp;rfr_id=info%3Asid%2Fen.wikipedia.org%3ARegdanvimab" class="Z3988"></span></li></ul> <div class="navbox-styles"><style data-mw-deduplicate="TemplateStyles:r1129693374">.mw-parser-output .hlist dl,.mw-parser-output .hlist ol,.mw-parser-output .hlist ul{margin:0;padding:0}.mw-parser-output .hlist dd,.mw-parser-output .hlist dt,.mw-parser-output .hlist li{margin:0;display:inline}.mw-parser-output .hlist.inline,.mw-parser-output .hlist.inline dl,.mw-parser-output .hlist.inline ol,.mw-parser-output .hlist.inline ul,.mw-parser-output .hlist dl dl,.mw-parser-output .hlist dl ol,.mw-parser-output .hlist dl ul,.mw-parser-output .hlist ol dl,.mw-parser-output .hlist ol ol,.mw-parser-output .hlist ol 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navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th id="Human" scope="row" class="navbox-group" style="width:1%">Human</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Efungumab" title="Efungumab">Efungumab</a><sup>†</sup></li></ul> </div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Virus" title="Virus">Viral</a></th><td class="navbox-list-with-group navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:1%">Human</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Ansuvimab" title="Ansuvimab">Ansuvimab</a></li> <li><a href="/wiki/Atoltivimab" title="Atoltivimab">Atoltivimab</a> (<a href="/wiki/Atoltivimab/maftivimab/odesivimab" title="Atoltivimab/maftivimab/odesivimab">+maftivimab/odesivimab</a>)</li> <li><a href="/w/index.php?title=Avdoralimab&amp;action=edit&amp;redlink=1" class="new" title="Avdoralimab (page does not exist)">Avdoralimab</a><sup>§</sup></li> <li><a href="/wiki/Bamlanivimab" title="Bamlanivimab">Bamlanivimab</a><sup>†</sup> (<a href="/wiki/Bamlanivimab/etesevimab" title="Bamlanivimab/etesevimab">+etesevimab</a>)<sup>†</sup></li> <li><a href="/wiki/Bebtelovimab" title="Bebtelovimab">Bebtelovimab</a><sup>§</sup></li> <li><a href="/wiki/Casirivimab" class="mw-redirect" title="Casirivimab">Casirivimab</a><sup>†</sup> (<a href="/wiki/Casirivimab/imdevimab" title="Casirivimab/imdevimab">+imdevimab</a>)</li> <li><a href="/wiki/Cilgavimab" class="mw-redirect" title="Cilgavimab">Cilgavimab</a><sup>†</sup> (<a href="/wiki/Tixagevimab/cilgavimab" title="Tixagevimab/cilgavimab">+tixagevimab</a>)<sup>†</sup></li> <li><a href="/wiki/Diridavumab" title="Diridavumab">Diridavumab</a><sup>§</sup></li> <li><a href="/wiki/Etesevimab" class="mw-redirect" title="Etesevimab">Etesevimab</a><sup>†</sup></li> <li><a href="/wiki/Exbivirumab" title="Exbivirumab">Exbivirumab</a><sup>§</sup></li> <li><a href="/wiki/Foravirumab" title="Foravirumab">Foravirumab</a><sup>§</sup></li> <li><a href="/wiki/Imdevimab" class="mw-redirect" title="Imdevimab">Imdevimab</a><sup>†</sup> (<a href="/wiki/Casirivimab/imdevimab" title="Casirivimab/imdevimab">+casirivimab</a>)</li> <li><a href="/wiki/Libivirumab" title="Libivirumab">Libivirumab</a><sup>§</sup></li> <li><a href="/wiki/Maftivimab" title="Maftivimab">Maftivimab</a></li> <li><a href="/wiki/Nirsevimab" title="Nirsevimab">Nirsevimab</a><sup>†</sup></li> <li><a href="/wiki/Odesivimab" title="Odesivimab">Odesivimab</a></li> <li><a href="/wiki/Pemivibart" title="Pemivibart">Pemivibart</a></li> <li><a href="/wiki/Rafivirumab" title="Rafivirumab">Rafivirumab</a><sup>§</sup></li> <li><a href="/wiki/Regavirumab" title="Regavirumab">Regavirumab</a><sup>§</sup></li> <li><a class="mw-selflink selflink">Regdanvimab</a></li> <li><a href="/wiki/Sevirumab" title="Sevirumab">Sevirumab</a><sup>†</sup></li> <li><a href="/wiki/Sotrovimab" title="Sotrovimab">Sotrovimab</a></li> <li><a href="/wiki/Suptavumab" title="Suptavumab">Suptavumab</a></li> <li><a href="/wiki/Tixagevimab" class="mw-redirect" title="Tixagevimab">Tixagevimab</a><sup>†</sup> (<a href="/wiki/Tixagevimab/cilgavimab" title="Tixagevimab/cilgavimab">+cilgavimab</a>)<sup>†</sup></li> <li><a href="/wiki/Tuvirumab" title="Tuvirumab">Tuvirumab</a><sup>§</sup></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Chimeric_antibody" class="mw-redirect" title="Chimeric antibody">Chimeric</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/ZMapp" title="ZMapp">Cosfroviximab</a></li> <li><a href="/wiki/ZMapp" title="ZMapp">Larcaviximab</a></li> <li><a href="/wiki/ZMapp" title="ZMapp">Porgaviximab</a></li> <li><a href="/wiki/Vilobelimab" title="Vilobelimab">Vilobelimab</a><sup>†</sup></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Humanized_antibody" title="Humanized antibody">Humanized</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Felvizumab" title="Felvizumab">Felvizumab</a><sup>§</sup></li> <li><a href="/wiki/Lenvervimab" title="Lenvervimab">Lenvervimab</a><sup>†</sup></li> <li><a href="/wiki/Motavizumab" title="Motavizumab">Motavizumab</a><sup>†</sup></li> <li><a href="/wiki/Palivizumab" title="Palivizumab">Palivizumab</a></li> <li><a href="/wiki/Suvizumab" title="Suvizumab">Suvizumab</a><sup>§</sup></li></ul> </div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Bacterial" class="mw-redirect" title="Bacterial">Bacterial</a></th><td class="navbox-list-with-group navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:1%">Human</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Nebacumab" title="Nebacumab">Nebacumab</a></li> <li><a href="/wiki/Panobacumab" title="Panobacumab">Panobacumab</a><sup>§</sup></li> <li><a href="/wiki/Raxibacumab" title="Raxibacumab">Raxibacumab</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Mouse</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Edobacomab" title="Edobacomab">Edobacomab</a><sup>§</sup></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Chimeric_antibody" class="mw-redirect" title="Chimeric antibody">Chimeric</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Pagibaximab" title="Pagibaximab">Pagibaximab</a><sup>†</sup></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Humanized</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Tefibazumab" title="Tefibazumab">Tefibazumab</a><sup>†</sup></li></ul> </div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Toxin" title="Toxin">Toxin</a></th><td class="navbox-list-with-group navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:1%">Human</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Actoxumab" title="Actoxumab">Actoxumab</a><sup>§</sup></li> <li><a href="/wiki/Bezlotoxumab" title="Bezlotoxumab">Bezlotoxumab</a></li> <li><a href="/wiki/Suvratoxumab" title="Suvratoxumab">Suvratoxumab</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Chimeric</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Obiltoxaximab" title="Obiltoxaximab">Obiltoxaximab</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Humanized</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Urtoxazumab" title="Urtoxazumab">Urtoxazumab</a><sup>§</sup></li></ul> </div></td></tr></tbody></table><div></div></td></tr><tr><td class="navbox-abovebelow" colspan="2"><div><div class="hlist"> <ul><li><sup>#</sup><a href="/wiki/WHO_Model_List_of_Essential_Medicines" title="WHO Model List of Essential Medicines">WHO-EM</a></li> <li><sup>‡</sup><a href="/wiki/List_of_withdrawn_drugs" title="List of withdrawn drugs">Withdrawn</a> from market</li> <li><a href="/wiki/Clinical_trial" title="Clinical trial">Clinical trials</a>: <ul><li><sup>†</sup><a href="/wiki/Phases_of_clinical_research#Phase_III" title="Phases of clinical research">Phase III</a></li> <li><sup>§</sup>Never to phase III</li></ul></li></ul> </div></div></td></tr></tbody></table></div> <style 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