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)].

Canada - English - Health Canada

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

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

Canada - English - Health Canada

viiv healthcare ulc - dolutegravir (dolutegravir sodium); rilpivirine (rilpivirine hydrochloride) - tablet - 50mg; 25mg - dolutegravir (dolutegravir sodium) 50mg; rilpivirine (rilpivirine hydrochloride) 25mg - hiv integrase inhibitors

Israel - English - Ministry of Health

j-c health care ltd - emtricitabine; rilpivirine as hydrochloride; tenofovir alafenamide as fumarate - film coated tablets - tenofovir alafenamide as fumarate 25 mg; emtricitabine 200 mg; rilpivirine as hydrochloride 25 mg - rilpivirine - odefsey is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 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

Israel - English - Ministry of Health

j-c health care ltd - emtricitabine; rilpivirine as hydrochloride; tenofovir alafenamide as fumarate - film coated tablets - tenofovir alafenamide as fumarate 25 mg; emtricitabine 200 mg; rilpivirine as hydrochloride 25 mg - rilpivirine - odefsey is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 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

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - rilpivirine hydrochloride 27.5mg equivalent to rilpivirine 25 mg;   - film coated tablet - 25 mg - active: rilpivirine hydrochloride 27.5mg equivalent to rilpivirine 25 mg   excipient: croscarmellose sodium hypromellose lactose monohydrate   macrogol 3000 magnesium stearate microcrystalline cellulose polysorbate 20 povidone titanium dioxide triacetin - 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-na?ve patients with viral load nmt 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 na?ve adult patients and on week 96 safety and efficacy analyses from the phase iib trial tmc278-c204 in treatment na?ve adult patients.

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - rilpivirine hydrochloride 27.50 mg eqv rilpivirine - tablet, film coated - 25 mg - rilpivirine hydrochloride 27.50 mg eqv rilpivirine 25 mg

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.    - rilpivirine hydrochloride - hiv infections - antivirals for systemic use - 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‑naïve patients 12 years of age and older with a viral load ≤ 100,000 hiv‑1 rna copies/ml. as with other antiretroviral medicinal products, genotypic resistance testing should guide the use of edurant.,

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - rilpivirine - hiv infections - antivirals for systemic use - rekambys is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (hiv 1) infection in adults who are virologically suppressed (hiv-1 rna < 50 copies/ml) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the nnrti and ini class.