European Union - English - EMA (European Medicines Agency)

mylan s.a.s. - lopinavir/ritonavir - hiv infections - antivirals for systemic use, - lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infected adults, adolescents and children above the age of 2 years.the choice of lopinavir/ritonavir to treat protease inhibitor experienced hiv-1 infected patients should be based on individual viral resistance testing and treatment history of patients.

Israel - English - Ministry of Health

j-c health care ltd - rilpivirine as hydrochloride - tablets - rilpivirine as hydrochloride 25 mg - rilpivirine - rilpivirine - edurant™, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in antiretroviral treatment-naïve adult patients with hiv-1 rna less than or equal to 100,000 copies/ml at the start of therapy.

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

janssen-cilag pty ltd - rilpivirine hydrochloride, quantity: 27.5 mg (equivalent: rilpivirine, qty 25 mg) - tablet, film coated - excipient ingredients: hypromellose; lactose monohydrate; macrogol 3000; croscarmellose sodium; silicon dioxide; magnesium stearate; povidone; polysorbate 20; titanium dioxide; triacetin; microcrystalline cellulose - edurant, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in antiretroviral treatment-naive adult patients with viral load less than or equal to 100,000 copies/ml at baseline. this indication is based on week 48 safety and efficacy analyses from 2 randomised double-blind, controlled phase iii trials in treatment-naive adult patients and on week 96 safety and efficacy analyses from the phase iib trial tmc278-c204 in treatment-naive adult patients (see clinical trials section).

Israel - English - Ministry of Health

j-c health care ltd - emtricitabine; rilpivirine as hydrochloride; tenofovir disoproxil as fumarate - film coated tablets - tenofovir disoproxil as fumarate 245 mg; rilpivirine as hydrochloride 25 mg; emtricitabine 200 mg - rilpivirine - rilpivirine - eviplera, a combination of two nucleoside analog hiv 1 reverse transcriptase inhibitors (emtricitabine and tenofovir disoproxil fumarate) and one non-nucleoside reverse transcriptase inhibitor (rilpivirine), is indicated for use as a complete regimen for the treatment of hiv-1 infection in adult patients with no antiretroviral treatment history and with hiv-1 rna less than or equal to 100,000 copies/ml at the start of therapy, and in certain virologically-suppressed (hiv-1 rna <50 copies/ml) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see below).the following points should be considered when initiating therapy with eviplera in adult patients with no antiretroviral treatment history: • more rilpivirine-treated subjects with hiv-1 rna greater than 100,000 copies/ml at the start of therapy experienced virologic failure (hiv-1 rna ≥50 copies/ml) compared to rilpivirine-treated subjects with hiv-1 rna less than or equal to 100,000 copies/ml [see clinical studies (14)]. • regardless of hiv-1 rna level at the start of therapy, more rilpivirine-treated subjects with cd4+ cell count less than 200 cells/mm3 experienced virologic failure compared to rilpivirine-treated subjects with cd4+ cell count greater than or equal to 200 cells/mm3 [see clinical studies (14)]. • the observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the nnrti class compared to efavirenz [see microbiology (12.4)]• more subjects treated with rilpivirine developed tenofovir and lamivudine/emtricitabine associated resistance compared to efavirenz [see microbiology (12.4)].

Israel - English - Ministry of Health

j-c health care ltd - emtricitabine; rilpivirine as hydrochloride; tenofovir disoproxil as fumarate - film coated tablets - tenofovir disoproxil as fumarate 245 mg; rilpivirine as hydrochloride 25 mg; emtricitabine 200 mg - rilpivirine - rilpivirine - eviplera, a combination of two nucleoside analog hiv 1 reverse transcriptase inhibitors (emtricitabine and tenofovir disoproxil fumarate) and one non-nucleoside reverse transcriptase inhibitor (rilpivirine), is indicated for use as a complete regimen for the treatment of hiv-1 infection in adult patients with no antiretroviral treatment history and with hiv-1 rna less than or equal to 100,000 copies/ml at the start of therapy, and in certain virologically-suppressed (hiv-1 rna <50 copies/ml) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see below).the following points should be considered when initiating therapy with eviplera in adult patients with no antiretroviral treatment history: • more rilpivirine-treated subjects with hiv-1 rna greater than 100,000 copies/ml at the start of therapy experienced virologic failure (hiv-1 rna ≥50 copies/ml) compared to rilpivirine-treated subjects with hiv-1 rna less than or equal to 100,000 copies/ml [see clinical studies (14)]. • regardless of hiv-1 rna level at the start of therapy, more rilpivirine-treated subjects with cd4+ cell count less than 200 cells/mm3 experienced virologic failure compared to rilpivirine-treated subjects with cd4+ cell count greater than or equal to 200 cells/mm3 [see clinical studies (14)]. • the observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the nnrti class compared to efavirenz [see microbiology (12.4)]• more subjects treated with rilpivirine developed tenofovir and lamivudine/emtricitabine associated resistance compared to efavirenz [see microbiology (12.4)].

Canada - English - Health Canada

janssen inc - rilpivirine (rilpivirine hydrochloride) - tablet - 25mg - rilpivirine (rilpivirine hydrochloride) 25mg - nonnucleoside reverse transcriptase inhibitors