美国 - 英文 - NLM (National Library of Medicine)

sunshine lake pharma co., ltd. - entecavir (unii: 5968y6h45m) (entecavir anhydrous - unii:nnu2o4609d) - entecavir tablets, usp are 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. 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. 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 defects is 2.7% in the u.s

美国 - 英文 - NLM (National Library of Medicine)

epic pharma, llc - entecavir (unii: 5968y6h45m) (entecavir anhydrous - unii:nnu2o4609d) - entecavir tablets are 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

爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

teva b.v. - entecavir - tablet - 0.5 milligram(s) - nucleoside and nucleotide reverse transcriptase inhibitors; entecavir

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

arrow pharma pty ltd - entecavir monohydrate -

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

arrow pharma pty ltd - entecavir monohydrate -

爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - entecavir monohydrate - film-coated tablet - 0.5 milligram(s) - nucleoside and nucleotide reverse transcriptase inhibitors; entecavir

爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - entecavir monohydrate - film-coated tablet - 1 milligram(s) - nucleoside and nucleotide reverse transcriptase inhibitors; entecavir

新西兰 - 英文 - Medsafe (Medicines Safety Authority)

viatris limited - entecavir monohydrate 0.53mg equivalent to 0.5 mg entecavir (anhydrous);   - film coated tablet - 0.5 mg - active: entecavir monohydrate 0.53mg equivalent to 0.5 mg entecavir (anhydrous)   excipient: crospovidone lactose monohydrate magnesium stearate microcrystalline cellulose opadry white ys-1r-7003 purified water - entecavir is indicated for the treatment of chronic hbv infection in adults with evidence of active liver inflammation.

新西兰 - 英文 - Medsafe (Medicines Safety Authority)

viatris limited - entecavir monohydrate 1.06mg equivalent to 1 mg entecavir (anhydrous);   - film coated tablet - 1 mg - active: entecavir monohydrate 1.06mg equivalent to 1 mg entecavir (anhydrous)   excipient: crospovidone lactose monohydrate magnesium stearate microcrystalline cellulose opadry white ys-1r-7003 purified water - entecavir is indicated for the treatment of chronic hbv infection in adults with evidence of active liver inflammation.

美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, inc. - entecavir (unii: 5968y6h45m) (entecavir anhydrous - unii:nnu2o4609d) - entecavir is indicated for the treatment of chronic hepatitis b virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (alt or ast) or histologically active disease. the following points should be considered when initiating therapy with entecavir: - • in adult patients, this indication is based on clinical trial data in nucleoside-inhibitor-treatment-naïve and lamivudine-resistant subjects with hbeag-positive and hbeag-negative hbv infection and compensated liver disease and a more limited number of subjects with decompensated liver disease. [see clinical studies (14.1) ]. pediatric use information is approved for bristol-myers squibb company’s baraclude® (entecavir) tablets. however, due to bristol-myers squibb company’s marketing exclusivity rights, this drug product is not labeled with that information. none. there are no adequate and well-controlled studies of