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HSA Approval

Imipenem/Cilastatin Labatec IV powder for Injection 500mg/500mg

Approval Number

SIN14589P

Drug Name

Imipenem/Cilastatin Labatec IV powder for Injection 500mg/500mg

Product Name

Imipenem/Cilastatin Labatec IV powder for Injection 500mg/500mg

Approval Date

August 13, 2014

Registrant

ALLIANCE PHARM PTE. LTD.

Licence Holder

ALLIANCE PHARM PTE. LTD.

Regulatory Information

Registrant

ALLIANCE PHARM PTE. LTD.

Licence Holder

ALLIANCE PHARM 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

J01DH51

ATC Item Name

imipenem and cilastatin

Manufacturer Information

Pharmaceutical Manufacturer

ALLIANCE PHARM PTE. LTD.

Manufacturers

ACS Dobfar S.p.A

ACS Dobfar SpA (Intermediate)

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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