Canada - English - Health Canada

mylan pharmaceuticals ulc - tenofovir disoproxil fumarate; emtricitabine - tablet - 300mg; 200mg - tenofovir disoproxil fumarate 300mg; emtricitabine 200mg - nucleoside and nucleotide reverse transcriptase inhibitors

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - emtricitabine 200mg; tenofovir disoproxil succinate 300.6mg equivalent to tenofovir disoproxil 245mg;   - film coated tablet - active: emtricitabine 200mg tenofovir disoproxil succinate 300.6mg equivalent to tenofovir disoproxil 245mg   excipient: croscarmellose sodium indigo carmine aluminium lake lactose monohydrate macrogol 3350 magnesium stearate microcrystalline cellulose polyvinyl alcohol pregelatinised maize starch purified talc purified water titanium dioxide - indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents.

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

macleods pharmaceuticals 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 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 populati

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

amneal pharmaceuticals ny llc - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 17 kg [see clinical studies (14)] . emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection. individuals must have a negative hiv-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep [see dosage and administration (2.2), warnings and precautions (5.2)] .  emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep is contraindicated in individuals with unknown or positive hiv-1 status [see warnings and precautions (5.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine and tenofovir disoproxil fumarate

Canada - English - Health Canada

jamp pharma corporation - tenofovir disoproxil fumarate; emtricitabine - tablet - 300mg; 200mg - tenofovir disoproxil fumarate 300mg; emtricitabine 200mg - nucleoside and nucleotide reverse transcriptase inhibitors

Canada - English - Health Canada

angita pharma inc. - tenofovir disoproxil fumarate; emtricitabine - tablet - 300mg; 200mg - tenofovir disoproxil fumarate 300mg; emtricitabine 200mg - nucleoside and nucleotide reverse transcriptase inhibitors

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

direct rx - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s) - 1.1 treatment of hiv-1 infection emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 17 kg [see clinical studies (14)]. 1.2 hiv-1 pre-exposure prophylaxis (prep) emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection. individuals must have a negative hiv-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep [see dosage and administration (2.2), warnings and precautions (5.2)]. emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep is contraindicated in individuals with unknown or positive hiv-1 status [see warnings and precautions (5.2)]. 8.1 pregnancy pregnancy exposure registry there is a pregnancy exposure registry that mo

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

redpharm drug, inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 17 kg [see clinical studies ( 14)] . emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection. individuals must have a negative hiv-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep [see dosage and administration ( 2.2), warnings and precautions ( 5.2)]. emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep is contraindicated in individuals with unknown or positive hiv-1 status [see warnings and precautions ( 5.2)] . pregnancy  exposure  registry there is a pregnancy exposure regist

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

direct rx - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s) - 1.1 treatment of hiv-1 infection emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 17 kg [see clinical studies (14)]. 1.2 hiv-1 pre-exposure prophylaxis (prep) emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection. individuals must have a negative hiv-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep [see dosage and administration (2.2), warnings and precautions (5.2)]. emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep is contraindicated in individuals with unknown or positive hiv-1 status [see warnings and precautions (5.2)]. 8.1 pregnancypregnancy exposure registry there is a pregnancy exposure registry that monitors pr

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

directrx - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - 1.1 treatment of hiv-1 infection emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 17 kg [see clinical studies (14)]. 1.2 hiv-1 pre-exposure prophylaxis (prep) emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at – risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection. individuals must have a negative hiv-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep [see dosage and administration (2.2), warnings and precautions (5.2)]. emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep are contraindicated in individuals with unknown or positive hiv-1 status [see warnings and precautions (5.2)]. 8.1 pregnancy teratogenic effects pregnancy exposure registry: there is a pregnancy e