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HSA Approval

PEXITAZ 500 POWDER FOR SOLUTION FOR INJECTION 500MG/VIAL

Approval Number

SIN15546P

Drug Name

PEXITAZ 500 POWDER FOR SOLUTION FOR INJECTION 500MG/VIAL

Product Name

PEXITAZ 500 POWDER FOR SOLUTION FOR INJECTION 500MG/VIAL

Approval Date

September 21, 2018

Registrant

RANBAXY (MALAYSIA) SDN. BHD.

Licence Holder

RANBAXY (MALAYSIA) SDN. BHD.

Regulatory Information

Registrant

RANBAXY (MALAYSIA) SDN. BHD.

Licence Holder

RANBAXY (MALAYSIA) SDN. BHD.

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Route of Administration

INTRAVENOUS

Medical Information

ATC Code

L01BA04

ATC Item Name

pemetrexed

Manufacturer Information

Pharmaceutical Manufacturer

RANBAXY (MALAYSIA) SDN. BHD.

Manufacturers

SUN PHARMACEUTICAL INDUSTRIES LIMITED

Active Ingredients

Ingredient Name

Pemetrexed disodium heptahydrate 698.97mg eqv Pemetrexed

Strength

500.00 mg/vial

Drug MonographPemetrexed

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