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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

entecavir, Quantity: 0.5 mg

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Entecavir

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

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

Authorization status:

Licence status A

Authorization date:

2016-07-22