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HSA Approval

PIPERACILLIN/TAZOBACTAM KABI POWDER FOR SOLUTION FOR INFUSION 4G/0.5G

SIN15308P

PIPERACILLIN/TAZOBACTAM KABI POWDER FOR SOLUTION FOR INFUSION 4G/0.5G

PIPERACILLIN/TAZOBACTAM KABI POWDER FOR SOLUTION FOR INFUSION 4G/0.5G

July 31, 2017

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

J01CR05

piperacillin and beta-lactamase inhibitor

Manufacturer Information

FRESENIUS KABI (SINGAPORE) PTE LTD

Labesfal - Laboratorios Almiro S.A. (Fresenius Kabi Group)

Fresenius Kabi iPSUM Srl (Pozzilli plant) (Intermediate)

Active Ingredients

Tazobactam sodium sterile 536.6 mg corresponding to Tazobactam

0.5g

Tazobactam

Piperacillin sodium sterile 4.170 g corresponding to Piperacillin

4.0 g

Piperacillin

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PIPERACILLIN/TAZOBACTAM KABI POWDER FOR SOLUTION FOR INFUSION 4G/0.5G - HSA Approval | MedPath