MedPath
HSA Approval

ICUNES® CONCENTRATE FOR SOLUTION FOR INFUSION 100MCG/ML

SIN16592P

ICUNES® CONCENTRATE FOR SOLUTION FOR INFUSION 100MCG/ML

ICUNES® CONCENTRATE FOR SOLUTION FOR INFUSION 100MCG/ML

September 6, 2022

NOVEM HEALTHCARE PTE LTD

NOVEM HEALTHCARE PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantNOVEM HEALTHCARE PTE LTD
Licence HolderNOVEM HEALTHCARE PTE LTD

Product Classification

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

Formulation Information

INFUSION, SOLUTION CONCENTRATE

INTRAVENOUS

Medical Information

N05CM18

dexmedetomidine

Manufacturer Information

NOVEM HEALTHCARE PTE LTD

PT. Novell Pharmaceutical Laboratories

Active Ingredients

Dexmedetomidine HCl eqv Dexmedetomidine

100 mcg/ml

Dexmedetomidine

Documents

Package Inserts

Icunes Concentrate PI.pdf

Approved: September 6, 2022

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