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HSA Approval

COMIRNATY, DISPERSION FOR INJECTION, 10 MICROGRAMS/DOSE (SINGLE-DOSE VIAL)

SIN17017P

COMIRNATY, DISPERSION FOR INJECTION, 10 MICROGRAMS/DOSE (SINGLE-DOSE VIAL)

COMIRNATY, DISPERSION FOR INJECTION, 10 MICROGRAMS/DOSE (SINGLE-DOSE VIAL)

May 31, 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

Raxtozinameran

10 μg/dose

Raxtozinameran

Documents

Package Inserts

Comirnaty monovalent PI.pdf

Approved: June 18, 2024

Download

Patient Information Leaflets

Comirnaty monovalent PIL.pdf

Approved: June 18, 2024

Download

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COMIRNATY, DISPERSION FOR INJECTION, 10 MICROGRAMS/DOSE (SINGLE-DOSE VIAL) - HSA Approval | MedPath