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HSA Approval

DIOLUX CONCENTRATE FOR SOLUTION FOR INJECTION 50MG/ML

Approval Number

SIN15782P

Drug Name

DIOLUX CONCENTRATE FOR SOLUTION FOR INJECTION 50MG/ML

Product Name

DIOLUX CONCENTRATE FOR SOLUTION FOR INJECTION 50MG/ML

Approval Date

August 16, 2019

Registrant

PHARMAKOE PTE. LTD.

Licence Holder

PHARMAKOE PTE. LTD.

Regulatory Information

Registrant

PHARMAKOE PTE. LTD.

Licence Holder

PHARMAKOE PTE. LTD.

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INJECTION, SOLUTION, CONCENTRATE

Route of Administration

INTRAVENOUS

Medical Information

ATC Code

C01BD01

ATC Item Name

amiodarone

Manufacturer Information

Pharmaceutical Manufacturer

PHARMAKOE PTE. LTD.

Manufacturers

Gland Pharma Ltd.

Active Ingredients

Ingredient Name

Amiodarone 47.3mg equivalent to Amiodarone hydrochloride

Strength

50mg/mL

Drug MonographAmiodarone

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