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HSA Approval

ARSENIC TRIOXIDE-AFT CONCENTRATED SOLUTION FOR INJECTION FOR INFUSION 10MG/10ML

SIN16961P

ARSENIC TRIOXIDE-AFT CONCENTRATED SOLUTION FOR INJECTION FOR INFUSION 10MG/10ML

ARSENIC TRIOXIDE-AFT CONCENTRATED SOLUTION FOR INJECTION FOR INFUSION 10MG/10ML

February 22, 2024

APEX PHARMA MARKETING PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantAPEX PHARMA MARKETING PTE. LTD.

Product Classification

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

Formulation Information

INJECTION, SOLUTION, CONCENTRATE

INTRAVENOUS

Medical Information

L01XX27

arsenic trioxide

Manufacturer Information

APEX PHARMA MARKETING PTE. LTD.

Kocak Farma Ilac ve Kimya Sanyi A.S. (Sterile Building 2)

Active Ingredients

Arsenic trioxide

10mg/10ml

Arsenic trioxide

Documents

Package Inserts

Arsenic Trioxide-AFT Concentrated Solution for Injection for Infusion 10mg-10ml PI.pdf

Approved: February 22, 2024

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ARSENIC TRIOXIDE-AFT CONCENTRATED SOLUTION FOR INJECTION FOR INFUSION 10MG/10ML - HSA Approval | MedPath