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HSA Approval

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

Approval Number

SIN16961P

Drug Name

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

Product Name

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

Approval Date

February 22, 2024

Registrant

APEX PHARMA MARKETING PTE. LTD.

Regulatory Information

Registrant

APEX PHARMA MARKETING PTE. LTD.

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INJECTION, SOLUTION, CONCENTRATE

Route of Administration

INTRAVENOUS

Medical Information

ATC Code

L01XX27

ATC Item Name

arsenic trioxide

Manufacturer Information

Pharmaceutical Manufacturer

APEX PHARMA MARKETING PTE. LTD.

Manufacturers

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

Active Ingredients

Ingredient Name

Arsenic trioxide

Strength

10mg/10ml

Drug MonographArsenic 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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