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HSA Approval

IRITEC CONCENTRATE FOR SOLUTION FOR INFUSION 40mg/2ml

SIN15058P

IRITEC CONCENTRATE FOR SOLUTION FOR INFUSION 40mg/2ml

IRITEC CONCENTRATE FOR SOLUTION FOR INFUSION 40mg/2ml

August 2, 2016

TRANET HOLDINGS PTE LTD

TRANET HOLDINGS PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantTRANET HOLDINGS PTE LTD
Licence HolderTRANET HOLDINGS PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INFUSION, SOLUTION CONCENTRATE

INTRAVENOUS

Medical Information

L01XX19

xl 01 xx 19

Manufacturer Information

TRANET HOLDINGS PTE. LTD.

VIANEX SA-PLANT C (PALINI PRODUCTION SITE)

Active Ingredients

Irinotecan Hydrochloride Trihydrate equ to Irinotecan34.66mg/vial

40mg/vial

Irinotecan

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IRITEC CONCENTRATE FOR SOLUTION FOR INFUSION 40mg/2ml - HSA Approval | MedPath