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		<title>AstraZeneca India announces the CDSCO approval for ‘Palivizumab’, a long-awaited preventive therapy for Respiratory Syncytial Virus</title>
		<link>https://newsmantra.in/astrazeneca-india-announces-the-cdsco-approval-for-palivizumab-a-long-awaited-preventive-therapy-for-respiratory-syncytial-virus/</link>
		
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				<category><![CDATA[Health]]></category>
		<category><![CDATA[AstraZeneca India]]></category>
		<category><![CDATA[AstraZeneca Pharma India Ltd.]]></category>
		<category><![CDATA[CDSCO approval]]></category>
		<category><![CDATA[Palivizumab]]></category>
		<category><![CDATA[Respiratory Syncytial Virus]]></category>
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					<description><![CDATA[<p>New Delhi (National), 30 September 2023: AstraZeneca Pharma India Ltd., a science-led biopharmaceutical company today announced the marketing approval from Central Drugs Standard Control Organisation (CDSCO) to import and market ‘Palivizumab’ injection 100 mg/ml (r-DNA origin) (50mg/0.5mL &#38; 100 mg/mL presentations in single-dose vials administered through intramuscular route) in India. RSV in...</p>
<p>The post <a href="https://newsmantra.in/astrazeneca-india-announces-the-cdsco-approval-for-palivizumab-a-long-awaited-preventive-therapy-for-respiratory-syncytial-virus/">AstraZeneca India announces the CDSCO approval for ‘Palivizumab’, a long-awaited preventive therapy for Respiratory Syncytial Virus</a> appeared first on <a href="https://newsmantra.in">newsmantra.in l Latest news on Politics, World, Bollywood, Sports, Delhi, Jammu &amp; Kashmir, Trending news | News Mantra</a>.</p>
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										<content:encoded><![CDATA[<p style="font-weight: 400;"><strong>New Delhi (National), 30 September 2023:</strong> AstraZeneca Pharma India Ltd., a science-led biopharmaceutical company today announced the marketing approval from Central Drugs Standard Control Organisation (CDSCO) to import and market ‘Palivizumab’ injection 100 mg/ml (r-DNA origin) (50mg/0.5mL &amp; 100 mg/mL presentations in single-dose vials administered through intramuscular route) in India.</p>
<p style="font-weight: 400;">RSV in children is a ‘major’ public health challenge faced across the globe today and is the second most common cause of death in children under 1 year of age (second only to malaria<sup>2</sup>). WHO estimates that RSV accounts for &gt;60% of acute respiratory infections in children and &gt;80% in infants &lt;1 year old<sup>3</sup>. The disease is responsible for nearly 50% of pneumonia cases and up to 90% of bronchiolitis cases among infants<sup>4</sup>. In India, RSV is the most common cause of hospitalisation in children &lt;1 years old<sup>5</sup>.</p>
<p style="font-weight: 400;">This innovative therapy is indicated for prevention of <strong>serious lower respiratory tract disease requiring hospitalisation caused by RSV in children at high risk for RSV disease:</strong></p>
<ul style="font-weight: 400;">
<li style="list-style-type: none;">
<ul>
<li>Infants born at <strong>35 weeks of gestation or less </strong>and &lt;6 months of age at the onset of the RSV season.</li>
<li>Children <strong>&lt;2 years </strong>of age and requiring treatment for bronchopulmonary dysplasia (<strong>BPD</strong>) within last 6 months.</li>
<li>Children <strong>&lt;2 years </strong>of age and with haemodynamically significant congenital heart disease (<strong>CHD</strong>).</li>
</ul>
</li>
</ul>
<p style="font-weight: 400;"><strong>Dr. Sanjeev Panchal, Country President and Managing Director, AstraZeneca India</strong>, <strong>said</strong>: “We are focused on bringing innovative therapies where we believe we can make the most meaningful difference to patients in India. Currently, there is neither a vaccine nor a targeted treatment<sup>1</sup> for RSV in India. <em>Palivizumab</em> however, is the only preventive therapy now approved in India that can help. This regulatory approval reflects country’s commitment towards enhancing RSV care for infants and saving lives. We are happy to be able to bring this therapy in the country and contribute in safeguarding at-risk children through our unwavering science that has the power to transform patient outcomes. We remain committed not only to providing access to existing management options but also to advancing RSV care and management through prevention, diagnosis, and treatment”.</p>
<p style="font-weight: 400;"><strong>About AstraZeneca Pharma India Ltd</strong></p>
<p style="font-weight: 400;">AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in four therapy areas &#8211; Oncology, Cardiovascular, Renal &amp; Metabolism and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Established in 1979, it is headquartered at Bengaluru, Karnataka and has a workforce of about 1,000 employees across the country committed to deliver great medicines to patients through innovative science and global excellence in development and commercialization.</p>
<p>The post <a href="https://newsmantra.in/astrazeneca-india-announces-the-cdsco-approval-for-palivizumab-a-long-awaited-preventive-therapy-for-respiratory-syncytial-virus/">AstraZeneca India announces the CDSCO approval for ‘Palivizumab’, a long-awaited preventive therapy for Respiratory Syncytial Virus</a> appeared first on <a href="https://newsmantra.in">newsmantra.in l Latest news on Politics, World, Bollywood, Sports, Delhi, Jammu &amp; Kashmir, Trending news | News Mantra</a>.</p>
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