Ireland - English - 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

Ireland - English - HPRA (Health Products Regulatory Authority)

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

New Zealand - English - 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.

New Zealand - English - 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.

Belgium - English - 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

Belgium - English - 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

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

zydus lifesciences limited - entecavir (unii: 5968y6h45m) (entecavir anhydrous - unii:nnu2o4609d) - entecavir 0.5 mg - 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 ma

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

acetris health, llc - entecavir (unii: 5968y6h45m) (entecavir anhydrous - unii:nnu2o4609d) - entecavir 0.5 mg - 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. the following points should be considered when initiating therapy with entecavir tablets: - 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)]. - in pediatric patients 2 years of age and older, this indication is based on clinical trial data in nucleoside-inhibitor-treatment-naïve and in a limited number of lamivudine-experienced subjects with hbeag-positive chronic hbv infection and compensated liver disease [see clinical studies (14

Canada - English - Health Canada

mint pharmaceuticals inc - entecavir (entecavir monohydrate) - tablet - 0.5mg - entecavir (entecavir monohydrate) 0.5mg - nucleosides and nucleotides

Canada - English - Health Canada

strides pharma canada inc - entecavir (entecavir monohydrate) - tablet - 0.5mg - entecavir (entecavir monohydrate) 0.5mg - nucleosides and nucleotides