Estats Units - anglès - 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

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

rex medical ltd - entecavir monohydrate 0.532mg equivalent to entecavir 0.5 mg - film coated tablet - 0.5 mg - active: entecavir monohydrate 0.532mg equivalent to entecavir 0.5 mg excipient: crospovidone hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose opadry white 04f58804 - entecavir tablets are indicated for the treatment of chronic hbv infection in adults with evidence of active liver inflammation.

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

rex medical ltd - entecavir monohydrate 1.064mg equivalent to entecavir 1 mg - film coated tablet - 1 mg - active: entecavir monohydrate 1.064mg equivalent to entecavir 1 mg excipient: crospovidone hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose opadry pink 03b14899 - entecavir tablets are indicated for the treatment of chronic hbv infection in adults with evidence of active liver inflammation.

Bèlgica - anglès - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

krka d.d. novo mesto d.d. - entecavir monohydrate 0,53 mg - eq. entecavir 0,5 mg - film-coated tablet - 0,5 mg - entecavir monohydrate 0.53 mg - entecavir

Bèlgica - anglès - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

krka d.d. novo mesto d.d. - entecavir monohydrate 1,06 mg - eq. entecavir 1 mg - film-coated tablet - 1 mg - entecavir monohydrate 1.06 mg - entecavir

Estats Units - anglès - NLM (National Library of Medicine)

yaopharma co., ltd. - entecavir (unii: 5968y6h45m) (entecavir anhydrous - unii:nnu2o4609d) - entecavir is 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. reference pop

Israel - anglès - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - entecavir as monohydrate - film coated tablets - entecavir as monohydrate 0.5 mg - entecavir - entecavir s.k. is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with: - compensated liver disease and evidence of active viral replication, and persistently elevated serum alanine aminotransferase (alt) levels.- decompensated liver disease.

Israel - anglès - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - entecavir as monohydrate - film coated tablets - entecavir as monohydrate 1 mg - entecavir - entecavir s.k. is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with:- compensated liver disease and evidence of active viral replication, and persistently elevated serum alanine aminotransferase (alt) levels.- decompensated liver disease.

Estats Units - anglès - NLM (National Library of Medicine)

yung shin pharm. ind. co., ltd. - 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 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 major

Israel - anglès - Ministry of Health

inovamed pharma ltd, israel - entecavir as monohydrate - film coated tablets - entecavir as monohydrate 0.5 mg - entecavir - entecavir inovamed is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with: - compensated liver disease and evidence of active viral replication, and persistently elevated serum alanine aminotransferase (alt) levels. - decompensated liver disease.