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<div id="overviewDiv" class="divsummary"><span class="divheading">Overview</span><div class="tableddiv"><table class="tablesummary"><tr><th>Case Number</th><th>Received Date</th><th>Finalised Date</th><th>Product/s</th><th>Responsible Person</th></tr><tr><td>CC-1PEC4N3Q/2019*</td><td>19/02/2019</td><td>30/10/2021</td><td><ul><li>BEXSERO - multi-component meningococcal B vaccine (recombinant, adsorbed) suspension for injection 0.5 ml pre-filled syringe with needle</li></ul></td><td><ul><li>GlaxoSmithKline Australia Pty Ltd</li></ul></td></tr></table></div></div><div id="summaryDiv" class="divsummary"><span class="divheading">Case Summary</span><div class="tableddiv"><span class="divheadingtwo">Alleged Breaches</span><div id="allegationAdvertisingTherapeutic Goods Act 1989" class="divadvertisingcode"><span class="allegationtype"><a href="https://www.legislation.gov.au/Series/C2004A03952" target="_blank">Therapeutic Goods Act 1989</a></span><ul><li>s42DL(7)(a) - Advertisement contains a restricted representation and neither an approval under section 42DF nor a permission under section 42DK is in force in relation to the restricted representation</li><li>s42DLB(4)(a) - Advertisement contains a restricted representation and neither an approval under section 42DF nor a permission under section 42DK is in force in relation to the restricted representation</li><li>s42DL(10) - Advertisement refers to substances, or goods containing substances, included in Schedule 3, 4 or 8 of the current Poisons Standard but not in Appendix H, other than a reference authorised or required by a government or government authority</li><li>s42DLB(7) - Advertisement refers to substances, or goods containing substances, included in Schedule 3, 4 or 8 of the current Poisons Standard but not in Appendix H, other than a reference authorised/required by a government/government authority (not including a foreign government/authority)</li><li>s42DM - Advertising contravenes the Code</li><li>s42DMA - Advertises or  causes the advertising, by any means, of therapeutic goods and the advertisement does not comply with the Therapeutic Goods Advertising Code.</li></ul></div><div id="allegationAdvertisingTherapeutic Goods Advertising Code (No.2) 2018" class="divadvertisingcode"><span class="allegationtype"><a href="https://www.legislation.gov.au/Series/F2018L01524" target="_blank">Therapeutic Goods Advertising Code (No.2) 2018</a></span><ul><li>s10(d)(iv) - Advertising for therapeutic goods must not contain any claim, statement, implication or representation that harmful consequences may result from the therapeutic goods not being used — unless it is permitted under section 42DK of the Act or approved under section 42DF of the Act</li></ul></div><span class="divheadingtwo">Summary</span><div class="breachDiv"></div></div></div><div id="actionsDiv" class="divsummary"><span class="divheading">Actions</span><div class="tableddiv"><table class="tablesummary"><tr><th>Date</th><th>Action</th><th> </th></tr><tr><td>08/01/2019</td><td>Warning Letter requiring action sent to advertiser</td><td>The TGA has contacted the advertiser to advise of an initial complaint received on 16 December 2018.</td></tr></table></div></div><div id="outcomeDiv" class="divsummary"><span class="divheading">Case Outcome</span><div class="tableddiv"><table class="tablesummary"><tr><th>Date</th><th>Case Outcome</th><th> </th></tr><tr><td>28/03/2019</td><td>Case resolved</td><td>The TGA has received multiple complaints on the matter. These complaints have been consolidated into one investigation.  Full details of the case summary are published at  CC-EM8YPJ5K/2018</td></tr></table></div></div><div id="previewDiv"></div>
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