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

juno pharmaceuticals pty ltd - darunavir, quantity: 800 mg - tablet, film coated - excipient ingredients: silicified microcrystalline cellulose; macrogol 4000; sodium chloride; iron oxide red; purified talc; titanium dioxide; hyprolose; crospovidone; polacrilin potassium; magnesium stearate; colloidal anhydrous silica; polyvinyl alcohol - adult patients,darunavir juno (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.,paediatric patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

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

juno pharmaceuticals pty ltd - darunavir, quantity: 600 mg - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; purified talc; polyvinyl alcohol; hyprolose; polacrilin potassium; macrogol 4000; sodium chloride; titanium dioxide; iron oxide red; silicified microcrystalline cellulose; colloidal anhydrous silica; iron oxide yellow - adult patients,darunavir juno (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.,paediatric patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

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

juno pharmaceuticals pty ltd - darunavir, quantity: 400 mg - tablet, film coated - excipient ingredients: sodium chloride; hyprolose; macrogol 4000; titanium dioxide; crospovidone; polacrilin potassium; iron oxide red; colloidal anhydrous silica; iron oxide yellow; purified talc; silicified microcrystalline cellulose; polyvinyl alcohol; magnesium stearate - adult patients,darunavir juno (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.,paediatric patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

Canada - English - Health Canada

jamp pharma corporation - darunavir - tablet - 400mg - darunavir 400mg - hiv protease inhibitors

Israel - English - Ministry of Health

j-c health care ltd - darunavir as ethanolate - film coated tablets - darunavir as ethanolate 75 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.

Israel - English - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - darunavir 300mg; darunavir 300mg - film coated tablet - 300 mg - active: darunavir 300mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry orange 85f93050 sodium starch glycolate active: darunavir 300mg excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry white 85f18422 purified water   sodium starch glycolate - darunavir viatris (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. darunavir viatris (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged greater than or equal to 6 years old and weighing at least 40 kg.

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

janssen-cilag pty ltd - darunavir, quantity: 800 mg - tablet, film coated - excipient ingredients: magnesium stearate; crospovidone; colloidal anhydrous silica; microcrystalline cellulose; hypromellose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - 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.,paediatric 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 (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

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

janssen-cilag pty ltd - darunavir -

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

janssen-cilag pty ltd - darunavir, quantity: 600 mg - tablet, film coated - excipient ingredients: magnesium stearate; purified talc; polyvinyl alcohol; macrogol 3350; crospovidone; colloidal anhydrous silica; microcrystalline cellulose; sunset yellow fcf aluminium lake; titanium dioxide - 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.,paediatric 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 (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.