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HSA Approval

GEMTERO (GEMCITABINE HYDROCHLORIDE) FOR INJECTION 1G/VIAL

SIN14558P

GEMTERO (GEMCITABINE HYDROCHLORIDE) FOR INJECTION 1G/VIAL

GEMTERO (GEMCITABINE HYDROCHLORIDE) FOR INJECTION 1G/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 1138mg eqv Gemcitabine

1000 mg

Gemcitabine

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