Canada - English - Health Canada

apotex inc - darunavir - tablet - 600mg - darunavir 600mg - hiv protease inhibitors

Canada - English - Health Canada

apotex inc - darunavir - tablet - 800mg - darunavir 800mg - hiv protease inhibitors

Canada - English - Health Canada

sandoz canada incorporated - darunavir - tablet - 600mg - darunavir 600mg - hiv protease inhibitors

Canada - English - Health Canada

sandoz canada incorporated - darunavir - tablet - 800mg - darunavir 800mg - hiv protease inhibitors

European Union - English - 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.

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

janssen-cilag pty ltd - darunavir, quantity: 75 mg - tablet, film coated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; crospovidone; titanium dioxide; purified talc; 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, quantity: 400 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; purified talc; microcrystalline cellulose; crospovidone; macrogol 3350; sunset yellow fcf aluminium lake; polyvinyl alcohol; magnesium stearate; 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.

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

janssen-cilag pty ltd - darunavir -

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

sandoz pty ltd - darunavir, quantity: 800 mg - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - adult patients darunavir (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 (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)

sandoz pty ltd - darunavir, quantity: 600 mg - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide; sunset yellow fcf aluminium lake; purified talc; polyvinyl alcohol; macrogol 3350 - adult patients darunavir (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 (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.