MedPath
HSA Approval

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

SIN17058P

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

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

August 1, 2024

BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantBIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.

Product Classification

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

Formulation Information

INJECTION

INTRAMUSCULAR

Medical Information

J07BN01

Manufacturer Information

BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.

Pfizer Manufacturing Belgium NV

Active Ingredients

Famtozinameran

5 μg/dose

Famtozinameran

Tozinameran

5 μg/dose

Tozinameran

Documents

Package Inserts

Approved Package Insert Comirnaty 5-5mcg bivalent SDV July 2024.pdf

Approved: August 1, 2024

Download

MedPath

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

© 2025 MedPath, Inc. All rights reserved.