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HSA Approval

GEMIBINE-1000 POWDER FOR SOLUTION FOR INFUSION 1 G VIAL

SIN15553P

GEMIBINE-1000 POWDER FOR SOLUTION FOR INFUSION 1 G VIAL

GEMIBINE-1000 POWDER FOR SOLUTION FOR INFUSION 1 G VIAL

September 28, 2018

ACCORD HEALTHCARE PRIVATE LIMITED

ACCORD HEALTHCARE PRIVATE LIMITED

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantACCORD HEALTHCARE PRIVATE LIMITED
Licence HolderACCORD HEALTHCARE PRIVATE LIMITED

Product Classification

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

Formulation Information

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

INTRAVENOUS

Medical Information

L01BC05

gemcitabine

Manufacturer Information

ACCORD HEALTHCARE PRIVATE LIMITED

INTAS PHARMACEUTICALS LIMITED

Active Ingredients

Gemcitabine HCl 1138.53 mg eqv Gemcitabine

1000.00 mg

Gemcitabine

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GEMIBINE-1000 POWDER FOR SOLUTION FOR INFUSION 1 G VIAL - HSA Approval | MedPath