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HSA Approval

IRITEC CONCENTRATE FOR SOLUTION FOR INFUSION 40mg/2ml

Approval Number

SIN15058P

Drug Name

IRITEC CONCENTRATE FOR SOLUTION FOR INFUSION 40mg/2ml

Product Name

IRITEC CONCENTRATE FOR SOLUTION FOR INFUSION 40mg/2ml

Approval Date

August 2, 2016

Registrant

TRANET HOLDINGS PTE LTD

Licence Holder

TRANET HOLDINGS PTE LTD

Regulatory Information

Registrant

TRANET HOLDINGS PTE LTD

Licence Holder

TRANET HOLDINGS PTE LTD

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INFUSION, SOLUTION CONCENTRATE

Route of Administration

INTRAVENOUS

Medical Information

ATC Code

L01XX19

ATC Item Name

xl 01 xx 19

Manufacturer Information

Pharmaceutical Manufacturer

TRANET HOLDINGS PTE. LTD.

Manufacturers

VIANEX SA-PLANT C (PALINI PRODUCTION SITE)

Active Ingredients

Ingredient Name

Irinotecan Hydrochloride Trihydrate equ to Irinotecan34.66mg/vial

Strength

40mg/vial

Drug MonographIrinotecan

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