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).

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

gilead sciences pty ltd - emtricitabine, quantity: 200 mg; tenofovir disoproxil fumarate, quantity: 300 mg; rilpivirine hydrochloride, quantity: 27.5 mg (equivalent: rilpivirine, qty 25 mg) - tablet, film coated - excipient ingredients: pregelatinised maize starch; microcrystalline cellulose; croscarmellose sodium; polysorbate 20; povidone; lactose monohydrate; magnesium stearate; titanium dioxide; hypromellose; sunset yellow fcf aluminium lake; triacetin; iron oxide red; macrogol 3350; indigo carmine aluminium lake - eviplera is indicated for the treatment of hiv infection in treatment-na?ve adult patients with plasma hiv-1 rna =< 100,000 copies/ml at the start of therapy. eviplera is also indicated 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 clinical trials). patients must not have a history of resistance to any of the components of eviplera (tenofovir df, emtricitabine or rilpivirine).

United States - English - NLM (National Library of Medicine)

janssen products, lp - rilpivirine hydrochloride (unii: 212wax8kdd) (rilpivirine - unii:fi96a8x663) - rilpivirine 25 mg - 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 patients 12 years of age and older and weighing at least 35 kg with plasma hiv-1 rna less than or equal to 100,000 copies/ml at the start of therapy. limitations of use: - more edurant 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 edurant treated subjects with hiv-1 rna less than or equal to 100,000 copies/ml [see clinical studies (14.1)] . edurant is indicated in combination with vocabria (cabotegravir) for short-term treatment of hiv-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed (hiv-1 rna less than 50 copies/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir

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

viiv healthcare pty ltd - rilpivirine hydrochloride, quantity: 27.5 mg (equivalent: rilpivirine, qty 25 mg); dolutegravir, quantity: 50 mg - tablet, film coated - excipient ingredients: macrogol 3350; silicified microcrystalline cellulose; povidone; sodium starch glycollate type a; polyvinyl alcohol; microcrystalline cellulose; magnesium stearate; lactose monohydrate; iron oxide yellow; croscarmellose sodium; iron oxide red; mannitol; purified talc; titanium dioxide; sodium stearylfumarate; polysorbate 20 - juluca (dolutegravir/rilpivirine) is indicated for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adults who are virologically-suppressed (hiv-1 rna less than 50 copies per ml) on a stable antiretroviral regimen for at least 6 months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor (see section 5.1 pharmacodynamic properties, clinical trials).

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.

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)].

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.

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

Canada - English - Health Canada

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