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.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - lamivudine 300 mg; abacavir 600 mg - film-coated tablet - 600 mg - 300 mg - lamivudine 300 mg; abacavir 600 mg - lamivudine and abacavir

Canada - English - Health Canada

apotex inc - abacavir (abacavir sulfate); lamivudine - tablet - 600mg; 300mg - abacavir (abacavir sulfate) 600mg; lamivudine 300mg - nucleoside and nucleotide reverse transcriptase inhibitors

Canada - English - Health Canada

apotex inc - abacavir (abacavir sulfate); lamivudine - tablet - 600mg; 300mg - abacavir (abacavir sulfate) 600mg; lamivudine 300mg - nucleoside and nucleotide reverse transcriptase inhibitors

Malta - English - Medicines Authority

accord healthcare limited - lamivudine; zidovudine - film-coated tablet - lamivudine 150 mg; zidovudine 300 mg - antivirals for systemic use

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - lamivudine, zidovudine - film-coated tablet - lamivudine 150 mg zidovudine 300 mg - antivirals for systemic use

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.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v.  - lamivudine, zidovudine - hiv infections - antivirals for systemic use - lamivudine/zidovudine teva is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (hiv) infection.

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

h.j. harkins company, inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s) - lamivudine 150 mg - lamivudine and zidovudine tablets, a combination of two nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of hiv-1 infection. lamivudine and zidovudine tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., anaphylaxis, stevens-johnson syndrome) to any of the components of the product. fetal risk summary: there are no adequate and well-controlled studies of lamivudine and zidovudine in pregnant women. clinical trial data demonstrate that maternal zidovudine treatment during pregnancy reduces vertical transmission of hiv-1 infection to the fetus. animal reproduction studies performed with lamivudine and zidovudine showed increased embryotoxicity and fetal malformations (zidovudine), and increased embryolethality (lamivudine). lamivudine and zidovudine tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. antiretroviral pregnancy registry: to mon

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

rebel distributors corp - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s) - lamivudine 150 mg - lamivudine and zidovudine tablets, a combination of two nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of hiv-1 infection. lamivudine and zidovudine tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., anaphylaxis, stevens-johnson syndrome) to any of the components of the product. fetal risk summary: there are no adequate and well-controlled studies of lamivudine and zidovudine in pregnant women. clinical trial data demonstrate that maternal zidovudine treatment during pregnancy reduces vertical transmission of hiv-1 infection to the fetus. animal reproduction studies performed with lamivudine and zidovudine showed increased embryotoxicity and fetal malformations (zidovudine), and increased embryolethality (lamivudine). lamivudine and zidovudine tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. antiretroviral pregnancy registry: to mon