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

arrotex pharmaceuticals pty ltd - lamivudine, quantity: 5 mg/ml - oral liquid, solution - excipient ingredients: hydrochloric acid; methyl hydroxybenzoate; sodium citrate dihydrate; propyl hydroxybenzoate; sucrose; citric acid; propylene glycol; sodium hydroxide; purified water; flavour - zeffix (lamivudine) is indicated for the treatment of children (2 years and above), adolescent and adult patients with chronic hepatitis b and evidence of hepatitis b virus (hbv) replication. this indication is based on changes in serological and histological markers in clinical studies of up to 2 years duration in adult patients with compensated liver disease and serological data up to 18 months in children and adolescents. children and adolescent also require evidence of active hepatic inflammation. (see clinical trials). the safety and efficacy of zeffix (lamivudine) have not been established in patients with decompensated liver disease in placebo controlled studies. however, zeffix (lamivudine) has been shown to reduce hbv dna levels prior to and post liver transplantation.

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

arrotex pharmaceuticals pty ltd - lamivudine, quantity: 100 mg - tablet, film coated - excipient ingredients: sodium starch glycollate; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; iron oxide red; macrogol 400 - zeffix (lamivudine) is indicated for the treatment of children (2 years and above), adolescent and adult patients with chronic hepatitis b and evidence of hepatitis b virus (hbv) replication. this indication is based on changes in serological and histological markers in clinical studies of up to 2 years duration in adult patients with compensated liver disease and serological data up to 18 months in children and adolescents. children and adolescent also require evidence of active hepatic inflammation. (see clinical trials). the safety and efficacy of zeffix (lamivudine) have not been established in patients with decompensated liver disease in placebo controlled studies. however, zeffix (lamivudine) has been shown to reduce hbv dna levels prior to and post liver transplantation.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - lamivudine - tablets - lamivudine 100 mg - lamivudine - lamivudine - zeffix is indicated for the treatment of chronic hepatitis b associated with the evidence of hepatitis b viral (hbv) replication and active liver inflammation in adults and also in children and adolescents aged 2 to 17 years old.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - lamivudine - solution (oral) - lamivudine 5 mg/ml - lamivudine - lamivudine - zeffix is indicated for the treatment of chronic hepatitis b associated with the evidence of hepatitis b viral (hbv) replication and active liver inflammation in adults and also in children and adolescents aged 2 to 17 years old.

European Union - English - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - lamivudine - hepatitis b, chronic - antivirals for systemic use - zeffix is indicated for the treatment of chronic hepatitis b in adults with: , compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active liver inflammation and / or fibrosis. initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate;, decompensated liver disease in combination with a second agent without cross-resistance to lamivudine.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - lamivudine 100mg;   - film coated tablet - 100 mg - active: lamivudine 100mg   excipient: magnesium stearate opadry butterscotch ys-1r-17307-a powdered cellulose sodium starch glycolate - zeffix is indicated for the treatment of adults and children aged 2 years and older with chronic hepatitis b and evidence of hepatitis b viruse (hbv) replication.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - lamivudine 5 mg/ml;   - oral solution - 5 mg/ml - active: lamivudine 5 mg/ml   excipient: banana flavour 59.256 ap0551 citric acid hydrochloric acid methyl hydroxybenzoate propyl hydroxybenzoate propylene glycol purified water sodium citrate dihydrate sodium hydroxide strawberry flavour 057883 ap0551 sucrose - zeffix is indicated for the treatment of adults and children aged 2 years and older with chronic hepatitis b and evidence of hepatitis b virus (hbv) replication.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - lamivudine - film coated tablets - lamivudine 100 mg - lamivudine - zeffix is indicated for the treatment of chronic hepatitis b associated with the evidence of hepatitis b viral (hbv) replication and active liver inflammation in adults and also in children and adolescents aged 2 to 17 years old.

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - lamivudine - tablet, film coated - 100 mg - lamivudine 100 mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - lamivudine - tablet - 100mg