Singapour - anglais - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - etravirine - tablet - 200mg/tablet - etravirine 200mg/tablet

Australie - anglais - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - etravirine -

Australie - anglais - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - etravirine, quantity: 100 mg - tablet - excipient ingredients: hypromellose; croscarmellose sodium; magnesium stearate; lactose monohydrate; microcrystalline cellulose; colloidal anhydrous silica - etravirine, in combination with other antiretroviral agents is indicated for the treatment of hiv-1 infection in antiretroviral treatment-experienced adults who have evidence of viral replication and resistance to non-nucleoside transcriptase inhibitors and other antiretroviral agents.,this indication is based on 24-week analyses from 2 randomised, double-blind, placebo controlled trials of etravirine. both studies were conducted in clinically advanced, 3-class antiretroviral (nnrti, n(t)rti, pi) treatment-experienced adults (see section 5.1 pharmacodynamic properties ? clinical trials).,treatment history of patients and genotypic testing should be performed to guide the use of etravirine.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - etravirine, quantity: 200 mg - tablet - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; hypromellose; magnesium stearate - etravirine, in combination with other antiretroviral agents is indicated for the treatment of hiv-1 infection in antiretroviral treatment-experienced adults who have evidence of viral replication and resistance to non-nucleoside transcriptase inhibitors and other antiretroviral agents.,this indication is based on 24-week analyses from 2 randomised, double-blind, placebo controlled trials of etravirine. both studies were conducted in clinically advanced, 3-class antiretroviral (nnrti, n(t)rti, pi) treatment-experienced adults (see section 5.1 pharmacodynamic properties ? clinical trials).,treatment history of patients and genotypic testing should be performed to guide the use of etravirine.

Israël - anglais - 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.

Israël - anglais - 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.

Singapour - anglais - HSA (Health Sciences Authority)

boehringer ingelheim singapore pte. ltd. - nevirapine - tablet - 200 mg - nevirapine 200 mg

Singapour - anglais - HSA (Health Sciences Authority)

boehringer ingelheim singapore pte. ltd. - nevirapine anhydrous - tablet, extended release - 400 mg - nevirapine anhydrous 400 mg

Israël - anglais - Ministry of Health

gilead sciences israel ltd - efavirenz; emtricitabine; tenofovir disoproxil as - film coated tablets - tenofovir disoproxil as 245 mg; emtricitabine 200 mg; efavirenz 600 mg - tenofovir disoproxil - tenofovir disoproxil - atripla is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults.

Royaume-Uni - anglais - MHRA (Medicines & Healthcare Products Regulatory Agency)

gilead sciences international ltd - efavirenz; tenofovir disoproxil fumarate; emtricitabine - tablet - 600mg ; 245mg ; 200mg