ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - didanosine 25mg;  ;   - chewable/dispersible tablet - 25 mg - active: didanosine 25mg     excipient: aspartame calcium carbonate magnesium hydroxide magnesium stearate mandarin orange, ext. microcrystalline cellulose povidone sorbitol

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - didanosine 50mg;  ;   - chewable/dispersible tablet - 50 mg - active: didanosine 50mg     excipient: aspartame dihydroxyaluminium sodium carbonate hydrated silica magnesium hydroxide magnesium stearate microcrystalline cellulose povidone sodium citrate dihydrate sucrose wintergreen oil

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - didanosine 50mg;  ;   - chewable/dispersible tablet - 50 mg - active: didanosine 50mg     excipient: aspartame calcium carbonate magnesium hydroxide magnesium stearate mandarin orange, ext. microcrystalline cellulose povidone sorbitol

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - didanosine 45mg;  ;   - powder for oral suspension - 45 mg - active: didanosine 45mg     excipient: citric acid dibasic sodium phosphate sodium citrate dihydrate sucrose

סינגפור - אנגלית - HSA (Health Sciences Authority)

gilead sciences singapore pte. ltd. - tenofovir disoproxil 245mg eqv tenofovir disoproxil fumarate - tablet, film coated - 300mg/ tablet - tenofovir disoproxil 245mg eqv tenofovir disoproxil fumarate 300 mg

דרום אפריקה - אנגלית - South African Health Products Regulatory Authority (SAHPRA)

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דרום אפריקה - אנגלית - South African Health Products Regulatory Authority (SAHPRA)

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דרום אפריקה - אנגלית - South African Health Products Regulatory Authority (SAHPRA)

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דרום אפריקה - אנגלית - South African Health Products Regulatory Authority (SAHPRA)

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ישראל - אנגלית - 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)].