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

novartis pharmaceuticals corporation - telbivudine (unii: 2oc4hkd3sf) (telbivudine - unii:2oc4hkd3sf) - telbivudine 600 mg

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

novartis pharmaceuticals australia pty ltd - telbivudine -

Singapore - English - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - telbivudine - tablet, film coated - 600.0mg - telbivudine 600.0mg

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - telbivudine 600mg;   - film coated tablet - 600 mg - active: telbivudine 600mg   excipient: colloidal silicon dioxide hypromellose macrogol 4000 magnesium stearate microcrystalline cellulose povidone purified talc sodium starch glycolate titanium dioxide - sebivo® is indicated for the treatment of chronic hepatitis b in patients with evidence of viral replication and active liver inflammation. this indication is based on virological, serological, biochemical and histological responses in adult patients with hbeag-positive and hbeag-negative chronic hepatitis b. the following points should be considered when initiating therapy with sebivo: 1. for hbeag-positive patients, sebivo treatment should only be initiated in patients with baseline hbv dna 2 x uln. 2. for hbeag-negative patients, sebivo treatment should only be initiated in patients with baseline hbv dna < 7 log 10 copies/ml

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - telbivudine 20 mg/ml;   - oral solution - 20 mg/ml - active: telbivudine 20 mg/ml   excipient: benzoic acid citric acid passionfruit flavour nitrogen purified water saccharin sodium sodium hydroxide - sebivo® is indicated for the treatment of chronic hepatitis b in patients with evidence of viral replication and active liver inflammation. this indication is based on virological, serological, biochemical and histological responses in adult patients with hbeag-positive and hbeag-negative chronic hepatitis b. the following points should be considered when initiating therapy with sebivo: 1. for hbeag-positive patients, sebivo treatment should only be initiated in patients with baseline hbv dna 2 x uln. 2. for hbeag-negative patients, sebivo treatment should only be initiated in patients with baseline hbv dna < 7 log 10 copies/ml

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

novartis pharmaceuticals uk ltd - telbivudine - tablet - 600mg

European Union - English - EMA (European Medicines Agency)

novartis europharm limited - telbivudine - hepatitis b, chronic - nucleoside and nucleotide reverse transcriptase inhibitors - sebivo is indicated for the treatment of chronic hepatitis b in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis.initiation of sebivo treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.

Canada - English - Health Canada

novartis pharmaceuticals canada inc - telbivudine - tablet - 600mg - telbivudine 600mg - nucleosides and nucleotides

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

novartis pharmaceuticals australia pty ltd - telbivudine -

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

novartis pharmaceuticals australia pty ltd - telbivudine -