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National Drug Formulary

MRESVIA DISPERSION FOR INJECTION IN PRE-FILLED SYRINGE 50MCG/0.5ML [SIN17482P]

Active ingredients: MRESVIA DISPERSION FOR INJECTION IN PRE-FILLED SYRINGE 50MCG/0.5ML

View product's general information
Last updated 24 April 2026

Product Info

MRESVIA DISPERSION FOR INJECTION IN PRE-FILLED SYRINGE 50MCG/0.5ML

[SIN17482P]

Product information

Active Ingredient and Strength

RNA-100-AR02 (MRNA-1345 ENCODING RSV F GLYCOPROTEIN IN PREFUSION CONFORMATION) - 0.05 MG/0.5 ML DOSE

Dosage Form

INJECTION, SOLUTION

Manufacturer and Country

MODERNATX, INC. (MANUFACTURER OF LMX-100 AND MRNA-1345 LNP) - UNITED STATES
ROVI PHARMA INDUSTRIAL SERVICES, S.A. (ROVI JC) - SPAIN

Registration Number

SIN17482P

Licence Holder

MODERNA BIOTECH SINGAPORE PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

J07BX05

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

4.1 Therapeutic indication

mRESVIA 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.

The use of this vaccine should be in accordance with official recommendations.

Dosing

4.2 Posology and method of administration

Posology

The recommended dose of mRESVIA is one single dose of 0.5 mL.

Paediatric population
The safety and efficacy of mRESVIA in children (from birth to less than 18 years of age) have not yet been established. No data are available.

Method of administration

For intramuscular injection only.

mRESVIA should be administered preferably in the deltoid muscle of the upper arm. The injection should be given using standard aseptic technique.

The vaccine must not be injected intravenously, subcutaneously or intradermally.

The vaccine should not be mixed with any other vaccines or medicinal products in the same syringe.

For instructions for preparation of the medicinal product before administration and special handling requirements, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Contraindications

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.