Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - entecavir, quantity: 0.5 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; crospovidone; hypromellose; titanium dioxide; purified talc; macrogol 6000 - entecavir sandoz 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 naive and lamividine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - entecavir, quantity: 1 mg - tablet, film coated - excipient ingredients: purified talc; hypromellose; titanium dioxide; lactose monohydrate; crospovidone; magnesium stearate; microcrystalline cellulose; macrogol 6000; iron oxide red; iron oxide yellow - entecavir sandoz 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 naive and lamividine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

United States - English - NLM (National Library of Medicine)

solco healthcare llc - entecavir anhydrous (unii: nnu2o4609d) (entecavir anhydrous - unii:nnu2o4609d) - entecavir anhydrous 0.5 mg - entecavir is indicated for the treatment of chronic hepatitis b virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (alt or ast) or histologically active disease. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to entecavir during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary prospective pregnancy data from the apr are not sufficient to adequately assess the risk of birth defects, miscarriage or adverse maternal or fetal outcomes. entecavir use during pregnancy has been evaluated in a limited number of individuals reported to the apr and the number of exposures to entecavir is insufficient to make a risk assessment compared to a reference population. the estimated background rate for major birth

Australia - English - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - entecavir, quantity: 1 mg - tablet, film coated - excipient ingredients: lactose monohydrate; povidone; crospovidone; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80; macrogol 400; iron oxide red - entecavir monohydrate 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 lamividine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - entecavir, quantity: 1 mg - tablet, film coated - excipient ingredients: lactose monohydrate; povidone; crospovidone; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80; iron oxide red; macrogol 400 - entecavir monohydrate 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 lamividine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - entecavir, quantity: 0.5 mg - tablet, film coated - excipient ingredients: lactose monohydrate; povidone; crospovidone; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80; macrogol 400 - entecavir monohydrate 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 lamividine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - entecavir, quantity: 0.5 mg - tablet, film coated - excipient ingredients: lactose monohydrate; povidone; crospovidone; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80; macrogol 400 - entecavir monohydrate 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 lamividine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - entecavir, quantity: 1 mg - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; crospovidone; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - 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

Australia - English - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - entecavir, quantity: 0.5 mg - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; crospovidone; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3000 - 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

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - entecavir, quantity: 1 mg - tablet, film coated - excipient ingredients: lactose monohydrate; povidone; crospovidone; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80; iron oxide red; macrogol 400 - entecavir monohydrate 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 lamividine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.