HSA Approval

GEMIBINE-1000 POWDER FOR SOLUTION FOR INFUSION 1 G VIAL

Approval Number

SIN15553P

Drug Name

Product Name

GEMIBINE-1000 POWDER FOR SOLUTION FOR INFUSION 1 G VIAL

Approval Date

September 28, 2018

Registrant

ACCORD HEALTHCARE PRIVATE LIMITED

Licence Holder

ACCORD HEALTHCARE PRIVATE LIMITED

Regulatory Information

Registrant

ACCORD HEALTHCARE PRIVATE LIMITED

Licence Holder

ACCORD HEALTHCARE PRIVATE LIMITED

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Route of Administration

INTRAVENOUS

Medical Information

ATC Code

L01BC05

ATC Item Name

gemcitabine

Manufacturer Information

Pharmaceutical Manufacturer

ACCORD HEALTHCARE PRIVATE LIMITED

Manufacturers

INTAS PHARMACEUTICALS LIMITED

Active Ingredients

Ingredient Name

Gemcitabine HCl 1138.53 mg eqv Gemcitabine

Strength

1000.00 mg

Drug MonographGemcitabine

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