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HSA Approval

Piperacillin/Tazobactam Sandoz Powder for solution for Injection/Infusion 4.5g vials

SIN13985P

Piperacillin/Tazobactam Sandoz Powder for solution for Injection/Infusion 4.5g vials

Piperacillin/Tazobactam Sandoz Powder for solution for Injection/Infusion 4.5g vials

July 7, 2011

NOVARTIS (SINGAPORE) PTE LTD

SANDOZ SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantNOVARTIS (SINGAPORE) PTE LTD
Licence HolderSANDOZ SINGAPORE PTE. LTD.

Product Classification

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

Formulation Information

POWDER, FOR SOLUTION

INTRAVENOUS

Medical Information

J01CR05

piperacillin and beta-lactamase inhibitor

Manufacturer Information

SANDOZ SINGAPORE PTE. LTD.

Sandoz GmbH

Sandoz Industrial Products S.A. (sterile intermediate manufacturer)

Shandong Anxin Pharmaceutical Co., Ltd. (Sterile Intermediate Manufacturer)

Active Ingredients

Piperacillin sodium 4.25310g eq to piperacillin

4000mg

Piperacillin

Tazobactam sodium 0.54733g eq to tazobactam

500mg

Tazobactam

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Piperacillin/Tazobactam Sandoz Powder for solution for Injection/Infusion 4.5g vials - HSA Approval | MedPath