Euroopan unioni - englanti - 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

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

arrotex pharmaceuticals pty ltd - entecavir monohydrate, quantity: 0.532 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; sodium starch glycollate; colloidal anhydrous silica; titanium dioxide; hypromellose; macrogol 400 - entecavir ch 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 lamivudine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

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

arrotex pharmaceuticals pty ltd - entecavir monohydrate, quantity: 1.065 mg - tablet, film coated - excipient ingredients: sodium starch glycollate; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; titanium dioxide; hypromellose; allura red ac aluminium lake; macrogol 400 - entecavir ch 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 lamivudine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

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

arrotex pharmaceuticals pty ltd - entecavir monohydrate, quantity: 0.532 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 400 - entecavir an 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 lamivudine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

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

arrotex pharmaceuticals pty ltd - entecavir monohydrate, quantity: 1.065 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; sodium starch glycollate; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; allura red ac aluminium lake; macrogol 400 - entecavir gppl 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 lamivudine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

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

arrotex pharmaceuticals pty ltd - entecavir monohydrate, quantity: 1.065 mg - tablet, film coated - excipient ingredients: sodium starch glycollate; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; hypromellose; allura red ac aluminium lake; macrogol 400 - entecavir an 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 lamivudine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

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

arrotex pharmaceuticals pty ltd - entecavir monohydrate, quantity: 0.532 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; magnesium stearate; colloidal anhydrous silica; titanium dioxide; hypromellose; macrogol 400 - entecavir gppl 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 lamivudine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

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

arrotex pharmaceuticals pty ltd - entecavir monohydrate, quantity: 1.065 mg - tablet, film coated - excipient ingredients: sodium starch glycollate; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; hypromellose; allura red ac aluminium lake; macrogol 400 - entecavir gxp 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 lamivudine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

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

arrotex pharmaceuticals pty ltd - entecavir monohydrate, quantity: 0.532 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; sodium starch glycollate; magnesium stearate; titanium dioxide; hypromellose; macrogol 400 - entecavir gxp 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 lamivudine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

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

sun pharma anz pty ltd - entecavir, quantity: 0.1 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.