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RotaTeq | FDA
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href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fvaccines-blood-biologics%2Fvaccines%2Frotateq" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a href="https://x.com/intent/tweet/?text=RotaTeq&url=https://www.fda.gov%2Fvaccines-blood-biologics%2Fvaccines%2Frotateq" target="_blank" class="lcds-share__btn lcds-share--default__btn-x-twitter js-share" id="twitter-share"> <svg class="icon-svg-inline" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> Post </a> </li> <li class="lcds-share__item hidden-xs"> <a href="https://www.linkedin.com/shareArticle?mini=true&url=https://www.fda.gov%2Fvaccines-blood-biologics%2Fvaccines%2Frotateq&title=RotaTeq&source=FDA" class="lcds-share__btn lcds-share--default__btn-linkedin js-share" id="linkedin-share" target="_blank"><span class="fa icon-linkedin" aria-hidden="true"></span>Linkedin</a> </li> <li class="lcds-share__item"> <a href="mailto:?subject=RotaTeq&body=https://www.fda.gov%2Fvaccines-blood-biologics%2Fvaccines%2Frotateq" class="lcds-share__btn lcds-share--default__btn-mail"><span class="fa icon-envelope" aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <p><strong>STN:</strong> BL 125122<br> <strong>Proper Name:</strong> Rotavirus Vaccine, Live, Oral, Pentavalent<br> <strong>Tradename:</strong> RotaTeq<br> <strong>Manufacturer:</strong> Merck Sharp & Dohme Corp<br> <strong>Indication:</strong> </p> <ul> <li>For the prevention of rotavirus gastroenteritis caused by the types G1, G2, G3, G4, and G9 for use in infants 6 weeks to 32 weeks of age.</li> </ul> <h2>Product Information</h2> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e506fd2c-1a61-4cf9-9344-58122fb439e8" href="/media/75718/download?attachment" title="Package Insert - RotaTeq">Package Insert - RotaTeq</a></li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="f858ab1d-7735-4fec-858e-87aab1d85694" href="/media/75727/download?attachment" title="Patient Information - RotaTeq">Patient Information - RotaTeq</a></li> </ul> <h2>Supporting Documents</h2> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="5359b3db-7aa9-42f3-8caa-106ac173124c" href="/media/141205/download?attachment" title="August 14, 2020 Approval Letter - RotaTeq">August 14, 2020 Approval Letter - RotaTeq</a></li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="14e6cb6a-0cd4-4ba3-84b7-6177dc624fba" href="/media/103471/download?attachment" title="February 22, 2017 Summary Basis for Regulatory Action - RotaTeq">February 22, 2017 Summary Basis for Regulatory Action - RotaTeq</a></li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="0aa6c273-f6fc-4528-a442-c65bdd8700c3" href="/media/103753/download?attachment" title="January 26, 2017 Statistical Review - Rota Teq">January 26, 2017 Statistical Review - Rota Teq</a></li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="e9f1d63f-ede2-4cd4-a8a4-d62847ffb69c" href="/media/103742/download?attachment" title="February 23, 2017 Clinical Review - Rota Teq">February 23, 2017 Clinical Review - Rota Teq</a></li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="0278ba71-ba0f-458c-bc90-7e4140e692be" href="/media/103799/download?attachment" title="February 23, 2017 Approval Letter - RotaTeq">February 23, 2017 Approval Letter - RotaTeq</a><br> To expand the indication to include prevention of rotavirus gastroenteritis caused by type G9</li> <li><a href="http://wayback.archive-it.org/7993/20170722071743/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094063.htm" target="_blank">Supporting Documents older than three years - RotaTeq</a></li> </ul> <h2>Related Information</h2> <ul> <li><a href="https://public4.pagefreezer.com/browse/FDA/01-11-2022T17:11/https://www.fda.gov/vaccines-blood-biologics/approved-products/rotateq-rotavirus-vaccine-questions-and-answers" target="_blank">RotaTeq (Rotavirus Vaccine) Questions and Answers - ARCHIVED</a></li> <li><a href="http://wayback.archive-it.org/7993/20170112213635/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108588.htm" target="_blank">FDA Approves New Vaccine to Prevent Rotavirus Gastroenteritis in Infants - ARCHIVED</a><br> Press Release: February 3, 2006</li> </ul> <h2>Related Links</h2> <ul> <li><a href="http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5610a3.htm" target="_blank">Postmarketing Monitoring of Intussusception After RotaTeq Vaccination</a></li> </ul> <!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET--> <!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET--> </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2020-08-17T11:26:00Z">08/17/2020</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> <h2 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