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HSA Approval

AZITHROMYCIN MEVON POWDER FOR SOLUTION FOR INFUSION 500 mg/vial

Approval Number

SIN14490P

Drug Name

AZITHROMYCIN MEVON POWDER FOR SOLUTION FOR INFUSION 500 mg/vial

Product Name

AZITHROMYCIN MEVON POWDER FOR SOLUTION FOR INFUSION 500 mg/vial

Approval Date

January 20, 2014

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, FOR SOLUTION

Route of Administration

INTRAVENOUS

Medical Information

ATC Code

J01FA10

ATC Item Name

azithromycin

Manufacturer Information

Pharmaceutical Manufacturer

NOVEM PHARMA PRIVATE LIMITED

Manufacturers

Laboratório Reig Jofré, S.A.

Active Ingredients

Ingredient Name

Azithromycin dihydrate 524.03mg eq. to Azithromycin

Strength

500.00mg

Drug MonographAzithromycin

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