Irland - engelsk - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - darunavir - film coated tablet - 400 milligram - protease inhibitors

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - darunavir, quantity: 800 mg - tablet, film coated - excipient ingredients: sodium starch glycollate type a; hypromellose; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; crospovidone; titanium dioxide; 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.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - darunavir, quantity: 600 mg - tablet, film coated - excipient ingredients: magnesium stearate; hypromellose; crospovidone; colloidal anhydrous silica; sodium starch glycollate type a; microcrystalline cellulose; titanium dioxide; 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.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - darunavir, quantity: 800 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; silicon dioxide; magnesium stearate; hypromellose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - prezcobix, a fixed dose combination of darunavir and cobicistat, is indicated in combination with other antiretroviral agents for the treatment of adult patients with human immunodeficiency virus- 1 (hiv-1) infection in:,- antiretroviral treatment-naive patients,- antiretroviral treatment-experienced patients with no darunavir resistance associated mutations and who have plasma hiv-1 rna <100,000 copies/ml,- antiretroviral treatment-experienced but hiv protease inhibitor-naive patients for whom hiv-1 genotype testing is unavailable (see section 4.2 dose and method of administration)

USA - engelsk - NLM (National Library of Medicine)

janssen products lp - darunavir ethanolate (unii: 33o78xf0bw) (darunavir - unii:yo603y8113) - darunavir 75 mg - prezista, co-administered with ritonavir (prezista/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection in adult and pediatric patients 3 years of age and older [see use in specific populations (8.4)and clinical studies (14)] . co-administration of prezista/ritonavir 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 (narrow therapeutic index). examples of these drugs and other contraindicated drugs (which may lead to reduced efficacy of darunavir) are listed below [see drug interactions (7.3)] . due to the need for co-administration of prezista with ritonavir, please refer to ritonavir prescribing information for a description of ritonavir contraindications. - alpha 1-adrenoreceptor antagonist: alfuzosin - anti-gout: colchicine, in patients with renal a

USA - engelsk - NLM (National Library of Medicine)

janssen products lp - darunavir ethanolate (unii: 33o78xf0bw) (darunavir - unii:yo603y8113), cobicistat (unii: lw2e03m5pg) (cobicistat - unii:lw2e03m5pg) - darunavir 800 mg - prezcobix 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 and pediatric patients weighing at least 40 kg with no darunavir resistance-associated substitutions (v11i, v32i, l33f, i47v, i50v, i54l, i54m, t74p, l76v, i84v, l89v). darunavir and cobicistat are both inhibitors of the cytochrome p450 3a (cyp3a) isoform. prezcobix should not be co-administered with medicinal products that are highly dependent on cyp3a for clearance and for which increased plasma concentrations are associated with serious and/or life threatening events (narrow therapeutic index). darunavir and cobicistat are both substrates of the cytochrome p450 3a (cyp3a) isoform. co-administration of prezcobix with cyp3a inducers may lead to lower exposures of darunavir and cobicistat and potential loss of efficacy of darunavir and possible resistance. examples of drugs that are contraindicated for co-administration w

USA - engelsk - NLM (National Library of Medicine)

remedyrepack inc. - darunavir ethanolate (unii: 33o78xf0bw) (darunavir - unii:yo603y8113), cobicistat (unii: lw2e03m5pg) (cobicistat - unii:lw2e03m5pg) - darunavir 800 mg - prezcobix ® 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). prezcobix is contraindicated in patients receiving the following co-administered drugs prezcobix is contraindicated in patients receiving the following co-administered drugs [see drug interactions (7.3) and clinical pharmacology (12.3)]. - alpha 1-adrenoreceptor antagonist: alfuzosin - anticonvulsants: carbamazepine, phenobarbital, phenytoin - anti-gout: colchicine, in patients with renal and/or hepatic impairment - antimycobacterial: rifampin - antipsychotics: lurasidone, pimozide - cardiac disorders: dronedarone, ivabradine, ranolazinecardiac disorders: dronedarone, ivabradine, ranolazine - ergot derivatives, e.g. dihydroergotamine, ergotamine, methylergonovine - gi motility agent: cisapride - he

Tanzania - engelsk - Tanzania Medicinces & Medical Devices Authority

hetero laboratories limited, india - darunavir , ritonavir tablets 400mg/50mg - tablets - 400/50

Tanzania - engelsk - Tanzania Medicinces & Medical Devices Authority

hetero laboratories limited, india - darunavir , ritonavir tablets 800mg/100mg - tablets - 800/100

Tanzania - engelsk - Tanzania Medicinces & Medical Devices Authority

hetero laboratories limited, india - darunavir , ritonavir tablets 400mg/50mg - tablets - 400/50