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SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (50 MICROGRAMS/50 MICROGRAMS)/ML DISPERSION FOR INJECTION [SIN16881P]
Active ingredients: SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (50 MICROGRAMS/50 MICROGRAMS)/ML DISPERSION FOR INJECTION
Last updated 26 October 2025
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SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (50 MICROGRAMS/50 MICROGRAMS)/ML DISPERSION FOR INJECTION
[SIN16881P]
Product information
Active Ingredient and Strength | DAVESOMERAN - 50 MCG/ML |
Dosage Form | INJECTION, SOLUTION |
Manufacturer and Country | ROVI PHARMA INDUSTRIAL SERVICES, S.A. - SPAIN |
Registration Number | SIN16881P |
Licence Holder | MODERNA BIOTECH SINGAPORE PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | J07BN01 |
4.1 Therapeutic indications
Spikevax bivalent Original/Omicron BA.4–5 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older who have previously received at least a primary vaccination course against COVID-19 (see sections 4.2 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
The use of this vaccine should be in accordance with official recommendations.
4.2 Posology and method of administration
Posology
The dose of Spikevax bivalent Original/Omicron BA.4–5 is 0.5 mL given intramuscularly.
Spikevax bivalent Original/Omicron BA.4–5 is only indicated for individuals who have previously received at least a primary vaccination course against COVID-19.
For details on the primary vaccination course for ages 12 and above, please refer to the package leaflet for Spikevax 0.2 mg/mL dispersion for injection.
Paediatric population
The safety and efficacy of Spikevax bivalent Original/Omicron BA.4–5 in children less than 12 years of age have not yet been established. No data are available.
Elderly
No dose adjustment is required in elderly individuals ≥65 years of age.
Method of administration
The vaccine should be administered intramuscularly. The preferred site is the deltoid muscle of the upper arm.
Do not administer this vaccine intravascularly, subcutaneously or intradermally.
The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.
For precautions to be taken before administering the vaccine, see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
For instructions regarding thawing, handling and disposal of the vaccine, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
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.