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HSA Approval

IMIPENEM /CILASTATIN KABI POWDER FOR SOLUTION FOR INFUSION 500MG/500MG

SIN14765P

IMIPENEM /CILASTATIN KABI POWDER FOR SOLUTION FOR INFUSION 500MG/500MG

IMIPENEM /CILASTATIN KABI POWDER FOR SOLUTION FOR INFUSION 500MG/500MG

March 26, 2015

FRESENIUS KABI (SINGAPORE) PTE LTD

FRESENIUS KABI (SINGAPORE) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantFRESENIUS KABI (SINGAPORE) PTE LTD
Licence HolderFRESENIUS KABI (SINGAPORE) PTE LTD

Product Classification

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

Formulation Information

INJECTION, POWDER, FOR SOLUTION

INTRAVENOUS

Medical Information

J01DH51

imipenem and cilastatin

Manufacturer Information

FRESENIUS KABI (SINGAPORE) PTE LTD

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

ACS Dobfar SpA (sterile bulk blend)

Active Ingredients

Imipenem Monohydrate 530mg/vial eqv Imipenem

500mg/ vial

Imipenem

Sodium Cilastatin 530mg/vial eqv Cilastatin

500mg/ vial

Cilastatin

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