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HSA Approval

CEFTAZIDIME KABI POWDER FOR SOLUTION FOR INJECTION 2G/VIAL

Approval Number

SIN15075P

Drug Name

CEFTAZIDIME KABI POWDER FOR SOLUTION FOR INJECTION 2G/VIAL

Product Name

CEFTAZIDIME KABI POWDER FOR SOLUTION FOR INJECTION 2G/VIAL

Approval Date

August 25, 2016

Registrant

FRESENIUS KABI (SINGAPORE) PTE LTD

Licence Holder

FRESENIUS KABI (SINGAPORE) PTE LTD

Regulatory Information

Registrant

FRESENIUS KABI (SINGAPORE) PTE LTD

Licence Holder

FRESENIUS KABI (SINGAPORE) PTE LTD

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INJECTION, POWDER, FOR SOLUTION

Route of Administration

INTRAVENOUS

Medical Information

ATC Code

J01DD02

ATC Item Name

ceftazidime

Manufacturer Information

Pharmaceutical Manufacturer

FRESENIUS KABI (SINGAPORE) PTE LTD

Manufacturers

Labesfal – Laboratorios Almiro, S.A.

Hanmi Fine Chemical Co. Ltd (Sterile Anhydrous Sodium Carbonate)

Hanmi Fine Chemical Co. Ltd (Sterile Ceftazidime buffered with sodium carbonate)

Active Ingredients

Ingredient Name

Ceftazidime Pentahydrate eqv Ceftazidime

Strength

2000mg/vial

Drug MonographCeftazidime

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