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AREXVY POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION 120MCG/0.5ML [SIN17008P]
Active ingredients: AREXVY POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION 120MCG/0.5ML
Last updated 26 October 2025
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Product Info
AREXVY POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION 120MCG/0.5ML
[SIN17008P]
Product information
Active Ingredient and Strength | RSVPREF3 ANTIGEN - 120 MCG/0.5 ML |
Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION |
Manufacturer and Country | GLAXOSMITHKLINE BIOLOGICALS SA - BELGIUM |
Registration Number | SIN17008P |
Licence Holder | GLAXOSMITHKLINE PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | J07BX05 |
Indications
Arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in:
adults 60 years of age and older;
adults 50 through 59 years of age who are at increased risk for RSV disease.
Consideration should be given to official vaccine recommendations on the appropriate use.
Dosage and Administration
Consideration should be given to official vaccine recommendations for immunisation schedules.
Posology
Arexvy is administered as a single dose of 0.5 mL.
The need for revaccination has not been established.
Paediatric population
The safety and efficacy of Arexvy in children have not been established.
Method of Administration
Arexvy is for intramuscular injection only, preferably in the deltoid muscle.
For instructions on reconstitution of the medicinal product before administration, see Use and Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Contraindications
Hypersensitivity to the active substances or to any component of the vaccine (see Qualitative and quantitative composition and List of Excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).