MedPath
HSA Approval

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

SIN14329P

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

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

March 20, 2013

NOVEM PHARMA PRIVATE LIMITED

NOVEM PHARMA PRIVATE LIMITED

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantNOVEM PHARMA PRIVATE LIMITED
Licence HolderNOVEM PHARMA PRIVATE LIMITED

Product Classification

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

Formulation Information

INJECTION, POWDER, FOR SOLUTION

INTRAVENOUS

Medical Information

J01D H51

xj 01 d h 51

Manufacturer Information

NOVEM PHARMA PRIVATE LIMITED

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

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

Active Ingredients

Imipenem Monohydrate 530mg corresponding to Imipenem

500mg

Imipenem

Sodium Cilastatin 530mg Corresponding to Cilastatin

500mg

Cilastatin

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Imipenem + Cilastatin Mevon Powder for solution for Injection 500 mg + 500 mg - HSA Approval | MedPath