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HSA Approval

ZOLETEM CONCENTRATE FOR SOLUTION FOR INFUSION 4MG/5ML

SIN15982P

ZOLETEM CONCENTRATE FOR SOLUTION FOR INFUSION 4MG/5ML

ZOLETEM CONCENTRATE FOR SOLUTION FOR INFUSION 4MG/5ML

July 30, 2020

PHARMAKOE PTE. LTD.

PHARMAKOE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantPHARMAKOE PTE. LTD.
Licence HolderPHARMAKOE PTE. LTD.

Product Classification

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

Formulation Information

INFUSION, SOLUTION CONCENTRATE

INTRAVENOUS

Medical Information

M05BA08

zoledronic acid

Manufacturer Information

PHARMAKOE PTE. LTD.

Gland Pharma Limited

Active Ingredients

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

4mg/5ml

Zoledronic acid

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ZOLETEM CONCENTRATE FOR SOLUTION FOR INFUSION 4MG/5ML - HSA Approval | MedPath