- Approval Id
- f24897e2e7740ee6
- Drug Name
- Spikevax 0.1 mg/mL dispersion for injection
- Product Name
- Spikevax 0.1 mg/mL dispersion for injection
- Approval Number
- SIN16835P
- Approval Date
- 2023-08-17
- Registrant
- MODERNA BIOTECH SINGAPORE PTE. LTD.
- Licence Holder
- MODERNA BIOTECH SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- **4.2 Posology and method of administration**
Posology
_Paediatric population_
The safety and efficacy of Spikevax XBB.1.5 in children less than 6 months of age have not yet been established. No data are available.
_Elderly population_
No dosage 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, or in infants and young children, the anterolateral aspect of the thigh.
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_.
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- **4.1 Therapeutic indications**
Spikevax XBB.1.5 is indicated for active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 in individuals 6 months of age and older (see sections 4.2 and 5.2 – _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.
- 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_.
- Atc Code
- J07BN01
- Atc Item Name
- covid-19, RNA-based vaccine
- Pharma Manufacturer Name
- MODERNA BIOTECH SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/17bdef34c1b4a1e9/moderna-biotech-singapore-pte-ltd
