- Approval Id
- 74ebf799d68fe38f
- Drug Name
- AREXVY POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION 120MCG/0.5ML
- Product Name
- AREXVY POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION 120MCG/0.5ML
- Approval Number
- SIN17008P
- Approval Date
- 2024-05-10
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p>Consideration should be given to official vaccine recommendations for immunisation schedules.</p>
<p><strong>Posology</strong></p>
<p>Arexvy is administered as a single dose of 0.5 mL.</p>
<p><em><u>Paediatric population</u></em></p>
<p>The safety and efficacy of Arexvy in children have not been established.</p>
<p><strong> Method of Administration</strong></p>
<p>Arexvy is for intramuscular injection only, preferably in the deltoid muscle.</p>
<p>For instructions on reconstitution of the medicinal product before administration, see <em>Use and Handling</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>Indications</strong></p>
<p>Arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in:</p>
<ul>
<li>adults 60 years of age and older,</li>
<li>adults 50 through 59 years of age who are at increased risk for RSV disease.</li>
</ul>
<p>Consideration should be given to official vaccine recommendations on the appropriate use.</p>
- Contraindications
- <p><strong> Contraindications</strong></p>
<p>Hypersensitivity to the active substances or to any component of the vaccine (see <em>Qualitative and quantitative composition</em> and <em>List of Excipients</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- J07BX05
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
