CIPLA ENTECAVIR entecavir (as monohydrate) 0.5 mg film coated tablets

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

entecavir monohydrate, Quantity: 0.532 mg

MAH:

Cipla Australia Pty Ltd

INN:

entecavir monohydrate

pharmaceutical_form:

Tablet, film coated

composition:

Excipient Ingredients: hyprolose; magnesium stearate; crospovidone; lactose monohydrate; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 6000

administration_route:

Oral

units_in_package:

30, 10

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

CIPLA 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.

leaflet_short:

Visual Identification: white to off-white, triangular shaped, biconvex, film coated tablet, debossed with 'E' on one side and plain on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

authorization_status:

Licence status A

authorization_date:

2016-12-19