MedPath
HSA Approval

VAXIGRIPTETRA SUSPENSION FOR INJECTION IN PREFILLED SYRINGE

SIN15477P

VAXIGRIPTETRA SUSPENSION FOR INJECTION IN PREFILLED SYRINGE

VAXIGRIPTETRA SUSPENSION FOR INJECTION IN PREFILLED SYRINGE

May 4, 2018

SANOFI-AVENTIS SINGAPORE PTE. LTD.

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantSANOFI-AVENTIS SINGAPORE PTE. LTD.
Licence HolderSANOFI-AVENTIS SINGAPORE PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION, SUSPENSION

**4.2. Posology and method of administration** **Posology** Based on clinical experience with the trivalent vaccine, annual revaccination with influenza vaccine is recommended given the duration of immunity provided by the vaccine and because circulating strains of influenza virus might change from year to year. Adults: one dose of 0.5 mL. _Paediatric population_ - Children from 6 months to 17 years of age: one dose of 0.5 mL. For children less than 9 years of age who have not previously been vaccinated, a second dose of 0.5 mL should be given after an interval of at least 4 weeks. - Infants less than 6 months of age: the safety and efficacy of VaxigripTetra administration (active immunisation) have not been established. No data are available. Through passive protection, one 0.5 mL dose administered to a pregnant woman may protect infants from birth to almost 6 months of age; however, not all infants may be protected (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Method of administration** The vaccine should be given by intramuscular or subcutaneous injection. The preferred site for intramuscular injection is the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in children 6 months through 35 months of age, or the deltoid muscle in children from 36 months of age and adults. _Precautions to be taken before handling or administering the medicinal product_ For instructions on preparation of the medicinal product before administration, see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.

SUBCUTANEOUS, INTRAMUSCULAR

Medical Information

**4.1. Therapeutic indications** VaxigripTetra is indicated for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine for: - active immunisation of adults, including pregnant women, and children from 6 months of age. The use of VaxigripTetra should be based on official recommendations.

**4.3. Contraindications** Hypersensitivity to the active substances, 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_ or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol-9. Vaccination should be postponed in case of moderate or severe febrile disease or acute disease.

J07BB02

influenza, inactivated, split virus or surface antigen

Manufacturer Information

SANOFI-AVENTIS SINGAPORE PTE. LTD.

SANOFI WINTHROP INDUSTRIE - LE TRAIT (Primary and secondary packager)

SANOFI PASTEUR – VAL DE REUIL (VDR)

Active Ingredients

INFLUENZA VIRUS (SH) B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, wild type)

15 mcg/0.5 ml

INFLUENZA VIRUS (SH) A/Darwin/9/2021 (H3N2) - like strain ( A/Darwin/9/2021, IVR-228)

15 mcg/0.5 ml

INFLUENZA VIRUS (SH) B/Austria/1359417/2021 - likestrain(B/Michigan/01/2021, wildtype)

15 mcg/0.5 ml

INFLUENZA VIRUS (SH) A/Sydney/5/2021 (H1N1)pdm09 - like strain (A/Sydney/5/2021, SAN-013)

15 mcg/0.5 ml

Documents

Package Inserts

VaxigripTetra PI (SH2023).pdf

Approved: February 13, 2023

Download

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

VAXIGRIPTETRA SUSPENSION FOR INJECTION IN PREFILLED SYRINGE - HSA Approval | MedPath