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HSA Approval

DEXMEDETOMIDINE KABI INJECTION 100MCG/ML

SIN15269P

DEXMEDETOMIDINE KABI INJECTION 100MCG/ML

DEXMEDETOMIDINE KABI INJECTION 100MCG/ML

June 12, 2017

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

INTRAVENOUS

Medical Information

N05CM18

dexmedetomidine

Manufacturer Information

FRESENIUS KABI (SINGAPORE) PTE LTD

GLAND PHARMA LIMITED

Active Ingredients

Dexmedetomidine Hydrochloride 118mcg/ml eqv Dexmedetomidine

100 mcg/ml

Dexmedetomidine

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