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

alphapharm pty ltd - tenofovir disoproxil maleate, quantity: 300 mg - tablet, film coated - excipient ingredients: lactose monohydrate; hyprolose; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide; hypromellose; triacetin; indigo carmine aluminium lake - tenofovir disoproxil viatris in combination with other antiretroviral agents is indicated for the treatment of hiv infected adults and paediatric patients 12 years of age and older.,tenofovir disoproxil viatris is indicated for the treatment of chronic hepatitis b in adults (see clinical trials).,tenofovir disoproxil viatris is indicated for the treatment of chronic hepatitis b in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, i.e. active viral replication, persistently elevated serum alt levels or evidence of active inflammation

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

camber pharmaceuticals, inc. - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate 300 mg - tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis b virus (hbv) in adults and pediatric patients 12 years of age and older. pediatric use information is approved for gilead sciences, inc.'s viread ® (tenofovir disoproxil fumarate) tablets. however, due to gilead sciences, inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to tenofovir disoproxil fumarate during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263.

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

remedyrepack inc. - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate 300 mg - tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients 2 years of age and older. tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients 2 years of age and older. the following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of hiv-1 infection:the following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of hiv-1 infection: - tenofovir disoproxil fumarate tablets should not be used in combination with atripla ® , complera ® , descovy ® , genvoya ® , odefsey ® , stribild ® , truvada ® , or vemlidy ® [ see warnings and precautions ( 5.4) ]. tenofovir disoproxil fumarate tablets should not be used in combination with atripla ® , complera ® , descovy ® , gen

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

teva pharmaceuticals usa, inc. - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate 300 mg - tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients 2 years of age and older. the following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of hiv-1 infection: - tenofovir disoproxil fumarate tablets should not be used in combination with atripla® , complera® , descovy® , genvoya® , odefsey® , stribild® , truvada® , or vemlidy® [see warnings and precautions (5.4) ]. tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis b in adults and pediatric patients 12 years of age and older. the following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of hbv infection: - the indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-naïve and subjects who were treatment-experienced w

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - tenofovir disoproxil succinate 300.6mg equivalent to tenofovir disoproxil 245 mg;   - film coated tablet - 245 mg - active: tenofovir disoproxil succinate 300.6mg equivalent to tenofovir disoproxil 245 mg   excipient: croscarmellose sodium indigo carmine aluminium lake lactose macrogol 3350 magnesium stearate microcrystalline cellulose polyvinyl alcohol pregelatinised maize starch purified talc purified water titanium dioxide - tenofovir disoproxil tablets in combination with other antiretroviral agents are indicated for the treatment of hiv-infected adults and paediatric patients 12 years of age and older.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245mg - film coated tablet - 300 mg - active: tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245mg excipient: colloidal silicon dioxide hyprolose lactose monohydrate magnesium stearate microcrystalline cellulose opadry blue 32k505018 - tenofovir disoproxil mylan is indicated for the treatment of chronic hepatitis b in adults and paediatric patients 12 years of age and older.

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

aurobindo pharma limited - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate 150 mg - tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis b virus (hbv) in adults and pediatric patients 2 years of age and older weighing at least 10 kg. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to tenofovir disoproxil fumarate during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no increase in the overall risk of major birth defects with first trimester exposure for tenofovir disoproxil fumarate (tdf) (2.1%) compared with the background rate for major birth defects of 2.7% in a u.s. reference popul

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

laurus labs limited - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate 300 mg - tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients 2 years of age and older. the following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of hiv-1 infection: - tenofovir disoproxil fumarate tablets should not be used in combination with atripla® , complera® , descovy® , genvoya® , odefsey® , stribild® , truvada® , or vemlidy® [see warnings and precautions (5.4)]. tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis b in adults and pediatric patients 12 years of age and older. the following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of hbv infection: • the indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-naïve and subjects who were treatment-exper

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

apotex corp. - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate 300 mg - tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients 2 years of age and older. the following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of hiv-1 infection: - tenofovir disoproxil fumarate tablets should not be used in combination with atripla ®, complera ®, descovy ®, genvoya ®, odefsey ®, stribild ®, truvada ®, or vemlidy ® [see warnings and precautions (5.4)] .tenofovir disoproxil fumarate tablets should not be used in combination with atripla ®, complera ®, descovy ®, genvoya ®, odefsey ®, stribild ®, truvada ®, or vemlidy ® [see warnings and precautions (5.4)] . tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis b in adults and pediatric patients 12 years of age and older . the following points should be considered when initiating therapy with tenofovir

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

remedyrepack inc. - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate 300 mg - tenofovir disoproxil fumarate is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis b virus (hbv) in adults and pediatric patients 12 years of age and older pediatric use information is approved for gilead sciences, inc.'s viread® (tenofovir disoproxil fumarate) tablets. however, due to gilead sciences, inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to tenofovir disoproxil fumarate during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no increase in the