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HSA Approval

GEMTERO (GEMCITABINE HYDROCHLORIDE) FOR INJECTION 200MG/VIAL

Approval Number

SIN14559P

Drug Name

GEMTERO (GEMCITABINE HYDROCHLORIDE) FOR INJECTION 200MG/VIAL

Product Name

GEMTERO (GEMCITABINE HYDROCHLORIDE) FOR INJECTION 200MG/VIAL

Approval Date

June 12, 2014

Registrant

MEDICELL PHARMACEUTICAL (S) PTE. LTD.

Licence Holder

MEDICELL PHARMACEUTICAL (S) PTE. LTD.

Regulatory Information

Registrant

MEDICELL PHARMACEUTICAL (S) PTE. LTD.

Licence Holder

MEDICELL PHARMACEUTICAL (S) PTE. LTD.

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

MEDICELL PHARMACEUTICAL (S) PTE. LTD.

Manufacturers

Hetero Labs Limited

Active Ingredients

Ingredient Name

Gemcitabine Hydrochloride 227.6mg eqv Gemcitabine

Strength

200 mg

Drug MonographGemcitabine

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