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HSA Approval

NEXVIAZYME POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL

SIN16989P

NEXVIAZYME POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL

NEXVIAZYME POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL

April 24, 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, POWDER, LYOPHILIZED, FOR SOLUTION

INTRAVENOUS

Medical Information

A16AB22

avalglucosidase alfa

Manufacturer Information

SANOFI-AVENTIS SINGAPORE PTE. LTD.

GENZYME IRELAND LIMITED

Active Ingredients

AVALGLUCOSIDASE ALFA

100mg/vial

Avalglucosidase alfa

Documents

Package Inserts

Nexviazyme infusion PI.pdf

Approved: April 24, 2024

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