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

amneal pharma australia pty ltd - entecavir, quantity: 1 mg - tablet, film coated - excipient ingredients: crospovidone; lactose monohydrate; microcrystalline cellulose; magnesium stearate; 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: 1 mg - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; microcrystalline cellulose; lactose monohydrate; 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: 1 mg - tablet, film coated - excipient ingredients: lactose monohydrate; crospovidone; magnesium stearate; microcrystalline cellulose; 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: 1 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; crospovidone; magnesium stearate; 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)

bristol-myers squibb australia pty ltd - entecavir, quantity: 1 mg - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; povidone; lactose monohydrate; microcrystalline cellulose; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - baraclude is indicated for the treatment of chronic hepatitis b virus infection 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 lamivudine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - entecavir - hepatitis b, chronic - antivirals for systemic use - entecavir accord is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with: , compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis., decompensated liver disease. , for both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with hbeag positive and hbeag negative hbv infection. with respect to patients with lamivudine-refractory hepatitis b. entecavir accord is also indicated for the treatment of chronic hbv infection in nucleoside naive paediatric patients from 2 to

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - entecavir monohydrate - hepatitis b - antivirals for systemic use - entecavir mylan is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis.decompensated liver disease.for both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with hbeag positive and hbeag negative hbv infection. with respect to patients with lamivudine-refractory hepatitis b.entecavir mylan is also indicated for the treatment of chronic hbv infection in nucleoside naive paediatric patients from 2 to

Canada - English - Health Canada

apotex inc - entecavir - tablet - 0.5mg - entecavir 0.5mg - nucleosides and nucleotides

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

pharmadax inc. - entecavir (unii: 5968y6h45m) (entecavir anhydrous - unii:nnu2o4609d) - entecavir tablets usp are 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 fo

Canada - English - Health Canada

sandoz canada incorporated - entecavir - tablet - 0.5mg - entecavir 0.5mg - nucleosides and nucleotides