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HSA Approval

DROSPERA FILM-COATED TABLETS 3 MG/0.02 MG

Approval Number

SIN14855P

Drug Name

DROSPERA FILM-COATED TABLETS 3 MG/0.02 MG

Product Name

DROSPERA FILM-COATED TABLETS 3 MG/0.02 MG

Approval Date

September 22, 2015

Registrant

INTEGA PTE LTD

Licence Holder

INTEGA PTE LTD

Regulatory Information

Registrant

INTEGA PTE LTD

Licence Holder

INTEGA 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

INTEGA PTE. LTD.

Manufacturers

Laboratorios León Farma S.A.

Active Ingredients

Ingredient Name

Drospirenone

Strength

3.00mg

Drug MonographDrospirenone

Ingredient Name

Ethinyl Estradiol Micronized

Strength

0.02mg

Drug MonographEthinylestradiol

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