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HSA Approval

ZOLETEM CONCENTRATE FOR SOLUTION FOR INFUSION 4MG/5ML

Approval Number

SIN15982P

Drug Name

ZOLETEM CONCENTRATE FOR SOLUTION FOR INFUSION 4MG/5ML

Product Name

ZOLETEM CONCENTRATE FOR SOLUTION FOR INFUSION 4MG/5ML

Approval Date

July 30, 2020

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

INFUSION, SOLUTION CONCENTRATE

Route of Administration

INTRAVENOUS

Medical Information

ATC Code

M05BA08

ATC Item Name

zoledronic acid

Manufacturer Information

Pharmaceutical Manufacturer

PHARMAKOE PTE. LTD.

Manufacturers

Gland Pharma Limited

Active Ingredients

Ingredient Name

Zoledronic acid monohydrate 4.26mg/5ml equivalent to Zoledronic acid

Strength

4mg/5ml

Drug MonographZoledronic acid

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