Imipenem + Cilastatin Mevon Powder for solution for Injection 500 mg + 500 mg

Approval Number

SIN14329P

Drug Name

Product Name

Imipenem + Cilastatin Mevon Powder for solution for Injection 500 mg + 500 mg

Approval Date

March 20, 2013

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

J01D H51

ATC Item Name

xj 01 d h 51

Manufacturer Information

Pharmaceutical Manufacturer

NOVEM PHARMA PRIVATE LIMITED

Manufacturers

ACS DOBFAR S.p.A (Filling of Drug product sterile bulk)

ACS Dobfar S.p.A. 2: Addetta Plant (Drug product bulk)

Active Ingredients

Ingredient Name

Imipenem Monohydrate 530mg corresponding to Imipenem

Strength

500mg

Drug MonographImipenem

Ingredient Name

Sodium Cilastatin 530mg Corresponding to Cilastatin

Strength

500mg

Drug MonographCilastatin

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Imipenem + Cilastatin Mevon Powder for solution for Injection 500 mg + 500 mg

Regulatory Information

Formulation Information

Medical Information

Manufacturer Information

Active Ingredients