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 - 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

sanofi israel ltd - levofloxacin as hemihydrate - film coated tablets - levofloxacin as hemihydrate 500 mg - levofloxacin - levofloxacin - tavanic tablets 500 mg is indicated in adults for the treatment of the following infections:- acute pyelonephritis and complicated urinary tract infections - chronic bacterial prostatitisin the below-mentioned infections, tavanic should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.- acute bacterial sinusitis - acute exacerbations of chronic obstructive pulmonary disease including bronchitis - community-acquired pneumonia- complicated skin and soft tissue infections.tavanic may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin.consideration should be given to official guidance on the appropriate use of antibacterial agents.

Israel - English - Ministry of Health

j-c health care ltd - darunavir as ethanolate - film coated tablets - darunavir as ethanolate 75 mg - darunavir - darunavir - adult patients:prezista, co-administered with ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv -1) infection. this indication is based on analyses of plasma hiv-1 rna levels and cd4+ cell counts from 2 controlled phase 3 trials of 48 weeks duration in antiretroviral treatment - naive and treatment-experienced patients and 2 controlled phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients .pediatric patients:prezista, co-administered with ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of hiv-1 infection in treatment-experienced pediatric patients 6 years of age and older .this indication is based on 24 week analyses of plasma hiv-1 rna levels and cd4+ cell counts from an open-label phase 2 trial in antiretroviral treatment-experienced pediatric patients 6 to < 18 years of age. in treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with prezista/rtv: - treatment history and, when available, genotypic or phenotypic testing, should guide the use of prezista/rtv. - the use of other active agents with prezista/rtv is associated with a greater likelihood of treatment response.

Israel - English - Ministry of Health

j-c health care ltd - darunavir as ethanolate - film coated tablets - darunavir as ethanolate 150 mg - darunavir - darunavir - adult patients:prezista, co-administered with ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv -1) infection. this indication is based on analyses of plasma hiv-1 rna levels and cd4+ cell counts from 2 controlled phase 3 trials of 48 weeks duration in antiretroviral treatment - naive and treatment-experienced patients and 2 controlled phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients .pediatric patients:prezista, co-administered with ritonavir (prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of hiv-1 infection in treatment-experienced pediatric patients 6 years of age and older .this indication is based on 24 week analyses of plasma hiv-1 rna levels and cd4+ cell counts from an open-label phase 2 trial in antiretroviral treatment-experienced pediatric patients 6 to < 18 years of age. in treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with prezista/rtv: - treatment history and, when available, genotypic or phenotypic testing, should guide the use of prezista/rtv. - the use of other active agents with prezista/rtv is associated with a greater likelihood of treatment response.

Namibia - English - Namibia Medicines Regulatory Council

aurobindo pharma (pty) ltd - didanosine - capsule - each capsule contains didanosine 200,0 mg

Namibia - English - Namibia Medicines Regulatory Council

aurobindo pharma (pty) ltd - didanosine - capsule - each capsule contains didanosine 250,0 mg

Namibia - English - Namibia Medicines Regulatory Council

aurobindo pharma (pty) ltd - didanosine - capsule - each capsule contains didanosine 400,0 mg

Namibia - English - Namibia Medicines Regulatory Council

ranbaxy (sa) (pty) ltd - didanosine - tablets - each delayed release capsule contains; didanosine 250,0 mg

Namibia - English - Namibia Medicines Regulatory Council

ranbaxy (sa) (pty) ltd - didanosine - tablets - each delayed release capsule contains; didanosine 400,0 mg