LEAH drospirenone 3mg / ethinylestradiol 20 micrograms (as betadex clathrate) tablet blister pack

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

ethinylestradiol, Quantity: 20 microgram; drospirenone, Quantity: 3 mg

Tilgængelig fra:

Bayer Australia Ltd

INN (International Name):

Drospirenone,ethinylestradiol

Lægemiddelform:

Tablet, uncoated

Sammensætning:

Excipient Ingredients: magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; purified talc; microcrystalline cellulose

Indgivelsesvej:

Oral

Enheder i pakken:

1 x 28 tablets, 3 x 28 tablets

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

LEAH is indicated for use as: - an oral contraceptive. - treatment of moderate acne vulgaris in women who seek oral contraception - treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control. The efficacy of LEAH for PMDD was not assessed beyond 3 cycles. LEAH has not been evaluated for treatment of PMS (premenstrual syndrome), see CLINICAL TRIALS.

Produkt oversigt:

Visual Identification: Small round white tablet debossed on one side with the letters "DP" in a regular hexagon.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorisation status:

Licence status A

Autorisation dato:

2014-08-04