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HSA Approval

CEFEPIME KABI POWDER FOR SOLUTION FOR INJECTION OR INFUSION 2 g/vial

SIN14988P

CEFEPIME KABI POWDER FOR SOLUTION FOR INJECTION OR INFUSION 2 g/vial

CEFEPIME KABI POWDER FOR SOLUTION FOR INJECTION OR INFUSION 2 g/vial

April 12, 2016

FRESENIUS KABI (SINGAPORE) PTE LTD

FRESENIUS KABI (SINGAPORE) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantFRESENIUS KABI (SINGAPORE) PTE LTD
Licence HolderFRESENIUS KABI (SINGAPORE) PTE LTD

Product Classification

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

Formulation Information

INJECTION, POWDER, FOR SOLUTION

INTRAVENOUS

Medical Information

J01DE01

cefepime

Manufacturer Information

FRESENIUS KABI (SINGAPORE) PTE LTD

Labesfal Laboratorios Almiro S.A. (Fresenius Kabi Group)(primary and secondary packing)

Fresenius Kabi iPSUM S.R.L

Active Ingredients

Cefepime dihydrochloride monohydrate 2378.5mg eqv cefepime

2000 mg/vial

Cefepime

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CEFEPIME KABI POWDER FOR SOLUTION FOR INJECTION OR INFUSION 2 g/vial - HSA Approval | MedPath