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HSA Approval

CLARISCAN SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.5 MMOL/ML

SIN15694P

CLARISCAN SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.5 MMOL/ML

CLARISCAN SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.5 MMOL/ML

May 24, 2019

GE HEALTHCARE PTE. LTD.

GE HEALTHCARE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantGE HEALTHCARE PTE. LTD.
Licence HolderGE HEALTHCARE PTE. LTD.

Product Classification

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

Formulation Information

INJECTION, SOLUTION

INTRAVENOUS

Medical Information

V08CA02

gadoteric acid

Manufacturer Information

GE HEALTHCARE PTE. LTD.

GE Healthcare AS (Oslo Site)

Active Ingredients

Gadoterate meglumine 376.9mg/ml eqv Gadoteric acid

279.3mg/ml

Gadoteric acid

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CLARISCAN SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.5 MMOL/ML - HSA Approval | MedPath