MedPath
HSA Approval

VYLOY™ POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL

SIN17197P

VYLOY™ POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL

VYLOY™ POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL

March 6, 2025

ASTELLAS PHARMA SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantASTELLAS PHARMA 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

L01FX31

Manufacturer Information

ASTELLAS PHARMA SINGAPORE PTE. LTD.

Baxter Oncology GmbH

Active Ingredients

Zolbetuximab

100mg/vial

Zolbetuximab

Documents

Package Inserts

Vyloy PI.pdf

Approved: March 6, 2025

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