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HSA Approval

ERTAPENEM MEVON POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 1G/VIAL

Approval Number

SIN15602P

Drug Name

ERTAPENEM MEVON POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 1G/VIAL

Product Name

ERTAPENEM MEVON POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 1G/VIAL

Approval Date

December 19, 2018

Registrant

NOVEM PHARMA PRIVATE LIMITED

Licence Holder

NOVEM PHARMA PRIVATE LIMITED

Regulatory Information

Registrant

NOVEM PHARMA PRIVATE LIMITED

Licence Holder

NOVEM PHARMA PRIVATE LIMITED

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Route of Administration

INTRAVENOUS

Medical Information

ATC Code

J01DH03

ATC Item Name

ertapenem

Manufacturer Information

Pharmaceutical Manufacturer

NOVEM PHARMA PRIVATE LIMITED

Manufacturers

ACS Dobfar S.p.A. (DP intermediate)

ACS Dobfar S.p.A. (primary and secondary packager)

Active Ingredients

Ingredient Name

ertapenem sodium 1.046 g eqv to ertapenem

Strength

1 g

Drug MonographErtapenem

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