MEROPENEM KABI POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500MG/VIAL

Approval Number

SIN15002P

Drug Name

Product Name

MEROPENEM KABI POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500MG/VIAL

Approval Date

May 4, 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

Medical Information

ATC Code

J01DH02

ATC Item Name

meropenem

Manufacturer Information

Pharmaceutical Manufacturer

FRESENIUS KABI (SINGAPORE) PTE LTD

Manufacturers

ACS Dobfar S.p.A. (Primary and Secondary Packaging)

ACS DOBFAR SpA 2: Addetta Site (DP Intermediate)

Active Ingredients

Ingredient Name

Meropenem Trihydrate 570mg equivalent to anhydrous Meropenem

Strength

500mg/vial

Drug MonographMeropenem

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MEROPENEM KABI POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500MG/VIAL

Regulatory Information

Formulation Information

Medical Information

Manufacturer Information

Active Ingredients

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Company

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