Kanada - inglise - Health Canada

gilead sciences canada inc - emtricitabine; elvitegravir; tenofovir alafenamide (tenofovir alafenamide hemifumarate); cobicistat - tablet - 200mg; 150mg; 10mg; 150mg - emtricitabine 200mg; elvitegravir 150mg; tenofovir alafenamide (tenofovir alafenamide hemifumarate) 10mg; cobicistat 150mg - hiv integrase inhibitors

Suurbritannia - inglise - MHRA (Medicines & Healthcare Products Regulatory Agency)

gilead sciences international ltd - tenofovir alafenamide; emtricitabine; cobicistat; elvitegravir - tablet - 10mg ; 200mg ; 150mg ; 150mg

Suurbritannia - inglise - MHRA (Medicines & Healthcare Products Regulatory Agency)

gilead sciences international ltd - cobicistat - tablet - 150mg

Uus-Meremaa - inglise - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - rifabutin 150mg - capsule - 150 mg - active: rifabutin 150mg - mycobutin is indicated for infections caused by mycobacteria, such as m. tuberculosis, m. avium intracellulare complex (mac) and other atypical mycobacteria. in infections caused by mac and other atypical mycobacteria such as m. xenopi, mycobutin has been shown to be effective for the treatment of both disseminated and localised disease, also in immunocompromised hiv positive patients. mycobutin is also indicated for the prophylaxis of m. avium intracellulare complex (mac) infections in immunodepressed patients with cd4 counts lower than or equal to 100/ml. in the treatment of tubercular disease, mycobutin has been shown to be effective for the treatment of patients with chronic pulmonary tuberculosis, even if caused by multidrug-resistant m. tuberculosis strains. in accordance with the commonly accepted criteria for the treatment of mycobacterial infections, mycobutin therapy should always be given in combination with other antimycobacterial drugs not belonging to the family of rifamycins.

Singapur - inglise - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - maraviroc - tablet, film coated - 150mg - maraviroc 150mg

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

gilead sciences pty ltd - cobicistat, quantity: 150 mg - tablet - excipient ingredients: croscarmellose sodium; magnesium stearate; microcrystalline cellulose; titanium dioxide; sunset yellow fcf aluminium lake; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - tybost is indicated as a pharmacokinetic enhancer of appropriate hiv-1 protease inhibitors in adults (see dosage and administration).

Uus-Meremaa - inglise - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - darunavir ethanolate 162.52mg equivalent to darunavir 150 mg - film coated tablet - 150 mg - active: darunavir ethanolate 162.52mg equivalent to darunavir 150 mg excipient: colloidal silicon dioxide crospovidone magnesium stearate opadry white 85f18422 purified water silicified microcrystalline cellulose - adult patients: prezista (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients.

Euroopa Liit - inglise - EMA (European Medicines Agency)

gilead sciences ireland uc - elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide - hiv infections - antivirals for systemic use, - genvoya is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 1 (hiv 1) without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.,

Kanada - inglise - Health Canada

gilead sciences canada inc - elvitegravir - tablet - 85mg - elvitegravir 85mg - hiv integrase inhibitors

Iisrael - inglise - Ministry of Health

j-c health care ltd - darunavir as ethanolate - film coated tablets - darunavir as ethanolate 150 mg - darunavir - darunavir - adult patients:prezista, co-administered with ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv -1) infection. this indication is based on analyses of plasma hiv-1 rna levels and cd4+ cell counts from 2 controlled phase 3 trials of 48 weeks duration in antiretroviral treatment - naive and treatment-experienced patients and 2 controlled phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients .pediatric patients:prezista, co-administered with ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of hiv-1 infection in treatment-experienced pediatric patients 6 years of age and older .this indication is based on 24 week analyses of plasma hiv-1 rna levels and cd4+ cell counts from an open-label phase 2 trial in antiretroviral treatment-experienced pediatric patients 6 to < 18 years of age. in treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with prezista/rtv: - treatment history and, when available, genotypic or phenotypic testing, should guide the use of prezista/rtv. - the use of other active agents with prezista/rtv is associated with a greater likelihood of treatment response.