ZOLTERO 4 ZOLEDRONIC ACID CONCENTRATE SOLUTION FOR INFUSION 4MG/5ML

Approval Number

SIN15791P

Drug Name

Product Name

ZOLTERO 4 ZOLEDRONIC ACID CONCENTRATE SOLUTION FOR INFUSION 4MG/5ML

Approval Date

August 27, 2019

Registrant

MEDICELL PHARMACEUTICAL (S) PTE. LTD.

Licence Holder

MEDICELL PHARMACEUTICAL (S) PTE. LTD.

Regulatory Information

Registrant

MEDICELL PHARMACEUTICAL (S) PTE. LTD.

Licence Holder

MEDICELL PHARMACEUTICAL (S) PTE. LTD.

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INJECTION, SOLUTION, CONCENTRATE

Route of Administration

INTRAVENOUS

Medical Information

ATC Code

M05BA08

ATC Item Name

zoledronic acid

Manufacturer Information

Pharmaceutical Manufacturer

MEDICELL PHARMACEUTICAL (S) PTE. LTD.

Manufacturers

Hetero Labs Limited

Active Ingredients

Ingredient Name

Zoledronic Acid Monohydrate 4.264mg/ml equivalent to Zoledronic Acid 4mg

Strength

4mg

Drug MonographZoledronic acid

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ZOLTERO 4 ZOLEDRONIC ACID CONCENTRATE SOLUTION FOR INFUSION 4MG/5ML

Regulatory Information

Formulation Information

Medical Information

Manufacturer Information

Active Ingredients

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