ENTECAVIR ML 0.5 mg entecavir (as monohydrate) tablet, blister pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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下载 公众评估报告 (PAR)
24-11-2017

有效成分:

entecavir, Quantity: 0.5 mg

可用日期:

Amneal Pharma Australia Pty Ltd

INN(国际名称):

Entecavir

药物剂型:

Tablet, film coated

组成:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; lactose monohydrate; crospovidone; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3000

给药途径:

Oral

每包单位数:

30

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults 16 years or older with evidence of active liver inflammation.,This indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment na?ve and lamivudine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease

產品總結:

Visual Identification: White to off white triangular shaped coated tablet debossed with "ENT" on one side and "0.5" on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

授权状态:

Licence status A

授权日期:

2016-07-22