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HSA Approval

PROART FILM COATED TABLETS 125MG

Approval Number

SIN15132P

Drug Name

PROART FILM COATED TABLETS 125MG

Product Name

PROART FILM COATED TABLETS 125MG

Approval Date

December 9, 2016

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

TABLET, FILM COATED

Route of Administration

ORAL

Medical Information

ATC Code

C02KX01

ATC Item Name

bosentan

Manufacturer Information

Pharmaceutical Manufacturer

RANBAXY (MALAYSIA) SDN. BHD.

Manufacturers

SUN PHARMACEUTICAL INDUSTRIES LIMITED

Active Ingredients

Ingredient Name

Bosentan Monohydrate 129.083mg eqv. to Bosentan

Strength

125.00mg

Drug MonographBosentan

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