MedPath
HSA Product

COMIRNATY ORIGINAL/OMICRON BA.4-5 CONCENTRATE FOR DISPERSION FOR INJECTION 5/5 MICROGRAMS/DOSE (MDV)

Product approved by Health Sciences Authority (SG)

Basic Information

COMIRNATY ORIGINAL/OMICRON BA.4-5 CONCENTRATE FOR DISPERSION FOR INJECTION 5/5 MICROGRAMS/DOSE (MDV)

INJECTION

Regulatory Information

SIN16915P

December 18, 2023

Prescription Only

Therapeutic

INTRAMUSCULAR

January 24, 2024

May 30, 2025

XJ07BN01

Company Information

BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.

BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.

Active Ingredients

Famtozinameran

Strength: 5 μg/dose

Tozinameran

Strength: 5 μg/dose

Detailed 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_.

Indication Information

**4.1 Therapeutic indications** COMIRNATY (Bivalent) (For Age 5 Years to <12 Years) (Vials with Orange Cap) is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 5 to <12 years of age. The use of this vaccine should be in accordance with official recommendations.

© Copyright 2025. All Rights Reserved by MedPath