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HSA Approval

BONETEM-Z SOLUTION FOR INFUSION 5MG/100ML

SIN15983P

BONETEM-Z SOLUTION FOR INFUSION 5MG/100ML

BONETEM-Z SOLUTION FOR INFUSION 5MG/100ML

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

INTRAVENOUS

Medical Information

M05BA08

zoledronic acid

Manufacturer Information

PHARMAKOE PTE. LTD.

Gland Pharma Limited

Active Ingredients

ZOLEDRONIC ACID MONOHYDRATE 5.33 mg/100 ml EQV ZOLEDRONIC ACID

5 mg/ 100 ml

Zoledronic acid

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BONETEM-Z SOLUTION FOR INFUSION 5MG/100ML - HSA Approval | MedPath