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HSA Approval

TASULOSE PROLONGED-RELEASE FILM-COATED TABLETS 400 mcg

Approval Number

SIN15573P

Drug Name

TASULOSE PROLONGED-RELEASE FILM-COATED TABLETS 400 mcg

Product Name

TASULOSE PROLONGED-RELEASE FILM-COATED TABLETS 400 mcg

Approval Date

November 1, 2018

Registrant

NOVARTIS (SINGAPORE) PTE LTD

Licence Holder

SANDOZ SINGAPORE PTE. LTD.

Regulatory Information

Registrant

NOVARTIS (SINGAPORE) PTE LTD

Licence Holder

SANDOZ SINGAPORE PTE. LTD.

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

TABLET, FILM COATED, EXTENDED RELEASE

Route of Administration

ORAL

Medical Information

ATC Code

G04CA02

ATC Item Name

tamsulosin

Manufacturer Information

Pharmaceutical Manufacturer

SANDOZ SINGAPORE PTE. LTD.

Manufacturers

Lek Pharmaceuticals d.d. (Ljubljana)

Lek Pharmaceuticals d.d. (Lendava) (Primary and Secondary Packager)

Active Ingredients

Ingredient Name

Tamsulosin hydrochloride

Strength

0.4mg

Drug MonographTamsulosin

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