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National Drug Formulary

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

View product's general information
Last updated 24 April 2026

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
GLAXOSMITHKLINE BIOLOGICALS SA (ADJUVANT) - BELGIUM
GLAXOSMITHKLINE VACCINES S.R.L. (ADJUVANT) - ITALY

Registration Number

SIN17008P

Licence Holder

GLAXOSMITHKLINE PTE LTD

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

J07BX05

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

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.

Dosing

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.

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

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).