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HSA Approval

MEROPENEM KABI POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500MG/VIAL

SIN15002P

MEROPENEM KABI POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500MG/VIAL

MEROPENEM KABI POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500MG/VIAL

May 4, 2016

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

J01DH02

meropenem

Manufacturer Information

FRESENIUS KABI (SINGAPORE) PTE LTD

ACS Dobfar S.p.A. (Primary and Secondary Packaging)

ACS DOBFAR SpA 2: Addetta Site (DP Intermediate)

Active Ingredients

Meropenem Trihydrate 570mg equivalent to anhydrous Meropenem

500mg/vial

Meropenem

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MEROPENEM KABI POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500MG/VIAL - HSA Approval | MedPath