Ethinyloestradiol / Drospirenone 20 microgram/3 mg Lupin ethinylestradiol/drospirenone 20 microgram/3 mg tablet blister pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

现在购买

公众评估报告 公众评估报告 (PAR)
19-10-2020

有效成分:

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

可用日期:

Lupin Australia Pty Limited

药物剂型:

Tablet, film coated

组成:

Excipient Ingredients: pregelatinised maize starch; lactose monohydrate; magnesium stearate; maize starch; titanium dioxide; hypromellose; macrogol 400

给药途径:

Oral

每包单位数:

2 x 28 tablets, 6 x 28 tablets, 3 x 28 tablets, 4 x 28 tablets, 1 x 28 tablets

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

Ethinylestradiol/ Drospirenone tablet is indicated for use as:,?an oral contraceptive.,?treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control. The efficacy of Ethinylestradiol/ Drospirenone tablet for PMDD was not assessed beyond 3 cycles. Ethinylestradiol/ Drospirenone tablet has not been evaluated for treatment of PMS (premenstrual syndrome).

產品總結:

Visual Identification: White to off-white round, biconvex film coated tablets, plain on both the sides.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

授权状态:

Registered

授权日期:

2020-09-11