Israel - English - Ministry of Health

gilead sciences israel ltd - cobicistate; elvitegravir; emtricitabine; tenofovir disoproxil as fumarate - film coated tablets - tenofovir disoproxil as fumarate 245 mg; emtricitabine 200 mg; cobicistate 150 mg; elvitegravir 150 mg - emtricitabine, tenofovir disoproxil, elvitegravir and cobicistat - stribild is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with hiv 1 without known mutations associated with resistance to any of the three antiretroviral agents in stribild.

Israel - English - Ministry of Health

gilead sciences israel ltd - cobicistate; elvitegravir; emtricitabine; tenofovir alafenamide - film coated tablets - tenofovir alafenamide 10 mg; emtricitabine 200 mg; cobicistate 150 mg; elvitegravir 150 mg - emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat - gendevra is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows:• in adults and adolescents aged from 12 years and with body weight at least 35 kg• in children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities.תוספת התוויה: 2/7/2019addition of new info to posology section: precaution in pregnant women

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

janssen-cilag pty ltd - tenofovir alafenamide, quantity: 10 mg; darunavir, quantity: 800 mg; cobicistat, quantity: 150 mg; emtricitabine, quantity: 200 mg - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; silicon dioxide; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - symtuza is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). genotypic testing should guide the use of symtuza (see section 4.2 dose and method of administration, section 4.4 special warnings and precautions for use and section 5.1 pharmacodynamic properties).

Israel - English - Ministry of Health

gilead sciences israel ltd - cobicistate; elvitegravir; emtricitabine; tenofovir alafenamide - film coated tablets - tenofovir alafenamide 10 mg; emtricitabine 200 mg; cobicistate 150 mg; elvitegravir 150 mg - emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat - gendevra is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows:• in adults and adolescents aged from 12 years and with body weight at least 35 kg• in children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities.תוספת התוויה: 2/7/2019addition of new info to posology section: precaution in pregnant women

Israel - English - Ministry of Health

gilead sciences israel ltd - cobicistate; elvitegravir; emtricitabine; tenofovir alafenamide - film coated tablets - tenofovir alafenamide 10 mg; emtricitabine 200 mg; cobicistate 150 mg; elvitegravir 150 mg - emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat - gendevra is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows:• in adults and adolescents aged from 12 years and with body weight at least 35 kg• in children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities.תוספת התוויה: 2/7/2019addition of new info to posology section: precaution in pregnant women

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

johnson & johnson sdn bhd - darunavir ethanolate; cobicistat on silicon dioxide -

Israel - English - Ministry of Health

j-c health care ltd - cobicistate; darunavir as ethanolate - film coated tablets - cobicistate 150 mg; darunavir as ethanolate 800 mg - darunavir - rezolsta is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv 1) infection in treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions (v11i, v32i, l33f, i47v, i50v, i54l, i54m, t74p, l76v, i84v, l89v).שינוי משטר מינון 2/4/2019pregnancy and postpartumtreatment with rezolsta during pregnancy results in low darunavir exposure (see sections 4.4 and 5.2). therefore, therapy with rezolsta should not be initiated during pregnancy, and women who become pregnant during therapy with rezolsta should be switched to an alternative regimen, see section 4.4 and 4.6. darunavir/ritonavir may be considered as an alternative.

New Zealand - English - Medsafe (Medicines Safety Authority)

gilead sciences (nz) - cobicistat 150mg;  ;  ;  ; elvitegravir 150mg;  ;  ; emtricitabine 200mg;  ;  ;  ;  ; tenofovir disoproxil fumarate 300mg;  ;  ;   - film coated tablet - active: cobicistat 150mg       elvitegravir 150mg     emtricitabine 200mg         tenofovir disoproxil fumarate 300mg       excipient: colloidal silicon dioxide croscarmellose sodium hyprolose lactose monohydrate magnesium stearate microcrystalline cellulose opadry green sodium laurilsulfate - stribild is indicated as a single tablet regimen for the treatment of hiv infection in treatment-naive adults. stribild is also indicated in certain virologically suppressed (hiv1 rna stribild is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide hiv-1 reverse transcriptase inhibitors.

New Zealand - English - Medsafe (Medicines Safety Authority)

gilead sciences (nz) - cobicistat 150mg (as a blend with silicon dioxide);  ;  ;  ; elvitegravir 150mg;  ;  ; emtricitabine 200mg;  ;  ;  ;  ; tenofovir alafenamide 10mg (as tenofovir alafenamide fumarate 11.2mg);   - tablet - active: cobicistat 150mg (as a blend with silicon dioxide)       elvitegravir 150mg     emtricitabine 200mg         tenofovir alafenamide 10mg (as tenofovir alafenamide fumarate 11.2mg)   excipient: colloidal silicon dioxide croscarmellose sodium hyprolose lactose monohydrate magnesium stearate microcrystalline cellulose opadry green 85f110095 sodium laurilsulfate - genvoya is indicated as a single tablet regimen for the treatment of hiv-1 infection in adults and paediatric patients weighing at least 25 kg who are either treatment-na?ve; or virologically suppressed (hiv-1 rna genvoya is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide hiv-1 reverse transcriptase inhibitors.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

gilead sciences international ltd - cobicistat - tablet - 150mg