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HSA Approval

GEMTERO (GEMCITABINE HYDROCHLORIDE) FOR INJECTION 200MG/VIAL

SIN14559P

GEMTERO (GEMCITABINE HYDROCHLORIDE) FOR INJECTION 200MG/VIAL

GEMTERO (GEMCITABINE HYDROCHLORIDE) FOR INJECTION 200MG/VIAL

June 12, 2014

MEDICELL PHARMACEUTICAL (S) PTE. LTD.

MEDICELL PHARMACEUTICAL (S) PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantMEDICELL PHARMACEUTICAL (S) PTE. LTD.
Licence HolderMEDICELL PHARMACEUTICAL (S) PTE. LTD.

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

MEDICELL PHARMACEUTICAL (S) PTE. LTD.

Hetero Labs Limited

Active Ingredients

Gemcitabine Hydrochloride 227.6mg eqv Gemcitabine

200 mg

Gemcitabine

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