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

New Zealand - English - Medsafe (Medicines Safety Authority)

rex medical ltd - entecavir monohydrate 0.532mg equivalent to entecavir 0.5 mg - film coated tablet - 0.5 mg - active: entecavir monohydrate 0.532mg equivalent to entecavir 0.5 mg excipient: crospovidone hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose opadry white 04f58804 - entecavir tablets are indicated for the treatment of chronic hbv infection in adults with evidence of active liver inflammation.

New Zealand - English - Medsafe (Medicines Safety Authority)

rex medical ltd - entecavir monohydrate 1.064mg equivalent to entecavir 1 mg - film coated tablet - 1 mg - active: entecavir monohydrate 1.064mg equivalent to entecavir 1 mg excipient: crospovidone hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose opadry pink 03b14899 - entecavir tablets are indicated for the treatment of chronic hbv infection in adults with evidence of active liver inflammation.

Israel - English - Ministry of Health

teva israel ltd - entecavir as monohydrate - film coated tablets - entecavir as monohydrate 0.5 mg - entecavir - entecavir teva is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with: - compensated liver disease and evidence of active viral replication, and persistently elevated serum alanine aminotransferase (alt) levels. - decompensated liver disease.

Israel - English - Ministry of Health

teva israel ltd - entecavir as monohydrate - film coated tablets - entecavir as monohydrate 1 mg - entecavir - entecavir teva is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with: - compensated liver disease and evidence of active viral replication, and persistently elevated serum alanine aminotransferase (alt) levels. - decompensated 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

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.