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HSA Approval

GVEZA FILM COATED TABLETS 3MG/ 0.03MG

Approval Number

SIN14996P

Drug Name

GVEZA FILM COATED TABLETS 3MG/ 0.03MG

Product Name

GVEZA FILM COATED TABLETS 3MG/ 0.03MG

Approval Date

April 28, 2016

Registrant

LOTUS INTERNATIONAL PTE. LTD.

Licence Holder

LOTUS INTERNATIONAL PTE. LTD.

Regulatory Information

Registrant

LOTUS INTERNATIONAL PTE. LTD.

Licence Holder

LOTUS INTERNATIONAL PTE. LTD.

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

TABLET, FILM COATED

Route of Administration

ORAL

Medical Information

ATC Code

G03AA12

ATC Item Name

drospirenone and ethinylestradiol

Manufacturer Information

Pharmaceutical Manufacturer

LOTUS INTERNATIONAL PTE. LTD.

Manufacturers

Laboratorios León Farma S.A

Active Ingredients

Ingredient Name

Ethinyl Estradiol Micronized

Strength

0.03 mg

Drug MonographEthinylestradiol

Ingredient Name

Drospirenone

Strength

3.00 mg

Drug MonographDrospirenone

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