MedPath
HSA Approval

GEMITA LYOPHILISED POWDER FOR SOLUTION FOR INJECTION 200 mg/vial

SIN14925P

GEMITA LYOPHILISED POWDER FOR SOLUTION FOR INJECTION 200 mg/vial

GEMITA LYOPHILISED POWDER FOR SOLUTION FOR INJECTION 200 mg/vial

January 25, 2016

FRESENIUS KABI (SINGAPORE) PTE LTD

FRESENIUS KABI (SINGAPORE) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantFRESENIUS KABI (SINGAPORE) PTE LTD
Licence HolderFRESENIUS KABI (SINGAPORE) 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

FRESENIUS KABI (SINGAPORE) PTE LTD

Fresenius Kabi Oncology Limited

Active Ingredients

GEMCITABINE HYDROCHLORIDE EQV GEMCITABINE

200 mg/vial

Gemcitabine

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