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HSA Approval

Piperacillin-Tazobactam Stragen For Injection 4.5g/vial

SIN13978P

Piperacillin-Tazobactam Stragen For Injection 4.5g/vial

Piperacillin-Tazobactam Stragen For Injection 4.5g/vial

June 20, 2011

NOVEM HEALTHCARE PTE LTD

NOVEM HEALTHCARE PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantNOVEM HEALTHCARE PTE LTD
Licence HolderNOVEM HEALTHCARE 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

NOVEM HEALTHCARE PTE LTD

MITIM S.r.l.

Fresenius Kabi Ipsum S.R.L. (sterile bulk) Muggio site

Fresenius Kabi Ipsum S.R.L. (sterile bulk) Villadose site

Fresenius Kabi Ipsum S.R.L. (sterile bulk) Pozzili site

Liosintex S.R.L. (sterile bulk)

Qilu Tianhe Pharmaceutical Company Limited (sterile bulk)

Active Ingredients

Piperacillin sodium 4170 mg equivalent to piperacillin

4000 mg

Piperacillin

Tazobactam sodium 536.6 mg equivalent to Tazobactam

500 mg

Tazobactam

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