COMIRNATY ORIGINAL/OMICRON BA.4-5 CONCENTRATE FOR DISPERSION FOR INJECTION 1.5/1.5 MICROGRAMS/DOSE

Approval Number

SIN17053P

Drug Name

Product Name

COMIRNATY ORIGINAL/OMICRON BA.4-5 CONCENTRATE FOR DISPERSION FOR INJECTION 1.5/1.5 MICROGRAMS/DOSE

Approval Date

July 25, 2024

Registrant

BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.

Regulatory Information

Registrant

BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INJECTION

Route of Administration

INTRAMUSCULAR

Medical Information

ATC Code

J07BN01

Manufacturer Information

Pharmaceutical Manufacturer

BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.

Manufacturers

Pfizer Manufacturing Belgium NV

Active Ingredients

Ingredient Name

Famtozinameran

Strength

1.5 μg/dose

Drug MonographFamtozinameran

Ingredient Name

Tozinameran

Strength

1.5 μg/dose

Drug MonographTozinameran

Documents

Package Inserts

Comirnaty bivalent 1.5-1.5 MDV approved PI July 2024.pdf

Approved: July 25, 2024

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COMIRNATY ORIGINAL/OMICRON BA.4-5 CONCENTRATE FOR DISPERSION FOR INJECTION 1.5/1.5 MICROGRAMS/DOSE

Regulatory Information

Formulation Information

Medical Information

Manufacturer Information

Active Ingredients

Documents

Package Inserts

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