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HSA Approval

CEFTRIAXONE KABI POWDER FOR SOLUTION FOR INJECTION 1G/VIAL

Approval Number

SIN15008P

Drug Name

CEFTRIAXONE KABI POWDER FOR SOLUTION FOR INJECTION 1G/VIAL

Product Name

CEFTRIAXONE KABI POWDER FOR SOLUTION FOR INJECTION 1G/VIAL

Approval Date

May 20, 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, INTRAMUSCULAR

Medical Information

ATC Code

J01DD04

ATC Item Name

ceftriaxone

Manufacturer Information

Pharmaceutical Manufacturer

FRESENIUS KABI (SINGAPORE) PTE LTD

Manufacturers

LABESFAL – Laboratorios Almiro, SA

Active Ingredients

Ingredient Name

Ceftriaxone Sodium 3.5 H2O 1193mg eqv Ceftriaxone

Strength

1000mg/ vial

Drug MonographCeftriaxone

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