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HSA Approval

BEYFORTUS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 50 MG/ 0.5 ML

SIN17137P

BEYFORTUS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 50 MG/ 0.5 ML

BEYFORTUS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 50 MG/ 0.5 ML

November 13, 2024

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantSANOFI-AVENTIS SINGAPORE PTE. LTD.

Product Classification

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

Formulation Information

INJECTION, SOLUTION

INTRAMUSCULAR

Medical Information

J06BD08

Manufacturer Information

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Patheon Manufacturing Services LLC

Active Ingredients

Nirsevimab

50 mg/ 0.5 mL

Nirsevimab

Documents

Package Inserts

Beyfortus Approved PI.pdf

Approved: November 13, 2024

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BEYFORTUS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 50 MG/ 0.5 ML - HSA Approval | MedPath