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HSA Approval

GEMIBINE-200 POWDER FOR SOLUTION FOR INFUSION 200 MG VIAL

SIN15554P

GEMIBINE-200 POWDER FOR SOLUTION FOR INFUSION 200 MG VIAL

GEMIBINE-200 POWDER FOR SOLUTION FOR INFUSION 200 MG 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 LTD.

Active Ingredients

Gemcitabine HCl 221.71 mg eqv Gemcitabine

200 mg

Gemcitabine

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