Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - emtricitabine; rilpivirine hydrochloride 27.5mg eqv rilpivirine; tenofovir disoproxil 245mg eqv tenofovir disoproxil fumarate - tablet, film coated - emtricitabine 200 mg; rilpivirine hydrochloride 27.5mg eqv rilpivirine 25 mg; tenofovir disoproxil 245mg eqv tenofovir disoproxil fumarate 300 mg

European Union - English - EMA (European Medicines Agency)

gilead sciences international ltd  - emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate - hiv infections - antivirals for systemic use - eviplera is indicated for the treatment of adults infected with human immunodeficiency virus type 1 (hiv-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (nnrti) class, tenofovir or emtricitabine, and with a viral load ≤ 100,000 hiv-1 rna copies/ml. as with other antiretroviral medicinal products, genotypic resistance testing and/or historical resistance data should guide the use of eviplera.

Canada - English - Health Canada

gilead sciences canada inc - emtricitabine; rilpivirine (rilpivirine hydrochloride); tenofovir disoproxil fumarate - tablet - 200mg; 25mg; 300mg - emtricitabine 200mg; rilpivirine (rilpivirine hydrochloride) 25mg; tenofovir disoproxil fumarate 300mg - nonnucleoside reverse transcriptase inhibitors

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)].

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

gilead sciences international ltd - emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate - tablet - 200mg ; 25mg ; 245mg

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 - 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)].