Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

gilead sciences, inc. - elvitegravir (unii: 4gdq854u53) (elvitegravir - unii:4gdq854u53), cobicistat (unii: lw2e03m5pg) (cobicistat - unii:lw2e03m5pg), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - elvitegravir 150 mg - stribild™ is indicated as a complete regimen for the treatment of hiv-1 infection in adults and pediatric patients 12 years of age and older weighing at least 35 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (hiv-1 rna less than 50 copies/ml) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of stribild [see clinical studies (14)] . coadministration of stribild is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. these drugs and other contraindicated drugs (which may lead to reduced efficacy of stribild and possible resistance) are listed below [see drug interactions (7.5) and clinical pharmacology (12.3)]. - alpha 1-adrenoreceptor antagonist: alfuzosin - anticonvu

Singapur - inglise - HSA (Health Sciences Authority)

gilead sciences singapore pte. ltd. - cobicistat on silicon dioxide 288.5mg eqv cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate 300.0mg eqv tenofovir disoproxil - tablet, film coated - cobicistat on silicon dioxide 288.5mg eqv cobicistat 150.0mg; elvitegravir 150.0mg; emtricitabine 200.0mg; tenofovir disoproxil fumarate 300.0mg eqv tenofovir disoproxil 245.0 mg

Singapur - inglise - HSA (Health Sciences Authority)

gilead sciences singapore pte. ltd. - cobicistat on silicon dioxide 288.5mg eqv cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate 11.2mg eqv tenofovir alafenamide fumarate free base - tablet, film coated - cobicistat on silicon dioxide 288.5mg eqv cobicistat 150mg; elvitegravir 150.0mg; emtricitabine 200.0mg; tenofovir alafenamide fumarate 11.2mg eqv tenofovir alafenamide fumarate free base 10.0mg

Kanada - inglise - Health Canada

janssen inc - darunavir (darunavir ethanolate); cobicistat; emtricitabine; tenofovir alafenamide (tenofovir alafenamide hemifumarate) - tablet - 800mg; 150mg; 200mg; 10mg - darunavir (darunavir ethanolate) 800mg; cobicistat 150mg; emtricitabine 200mg; tenofovir alafenamide (tenofovir alafenamide hemifumarate) 10mg - antiretrovirals

Iisrael - inglise - Ministry of Health

j-c health care ltd - darunavir as ethanolate - film coated tablets - darunavir as ethanolate 400 mg - darunavir - darunavir - prezista , co-administered with 100 mg ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection for over 18 years of age.

Iisrael - inglise - Ministry of Health

j-c health care ltd - darunavir as ethanolate - film coated tablets - darunavir as ethanolate 600 mg - darunavir - darunavir - prezista , co-administered with 100 mg ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection for over 18 years of age.

Euroopa Liit - inglise - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - hiv infections - antivirals for systemic use - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight.prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg).in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista.prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection.prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated.for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista.prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection.prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg).prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve.art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - cobicistat; tenofovir disoproxil fumarate; emtricitabine; elvitegravir -

Kanada - inglise - Health Canada

bristol-myers squibb canada - atazanavir (atazanavir sulfate); cobicistat - tablet - 300mg; 150mg - atazanavir (atazanavir sulfate) 300mg; cobicistat 150mg - hiv protease inhibitors

Kanada - inglise - Health Canada

janssen inc - darunavir (darunavir ethanolate); cobicistat - tablet - 800mg; 150mg - darunavir (darunavir ethanolate) 800mg; cobicistat 150mg - hiv protease inhibitors