몰타 - 영어 - Medicines Authority

johnson & johnson hellas consumer ae aegialias & epidavrou 4, maroussi, 15125, athens, greece - miconazole - oral gel - miconazole 20 mg/g - stomatological preparations

이스라엘 - 영어 - 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.

영국 - 영어 - MHRA (Medicines & Healthcare Products Regulatory Agency)

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

유럽 연합 - 영어 - EMA (European Medicines Agency)

zentiva k.s. - efavirenz, emtricitabine, tenofovir disoproxil, phosphate - hiv infections - antivirals for systemic use, - efavirenz/emtricitabine/tenofovir disoproxil zentiva is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. it is indicated for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adults aged 18 years and over with virologic suppression to hiv-1 rna levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in efavirenz/emtricitabine/tenofovir disoproxil zentiva prior to initiation of their first antiretroviral treatment regimen., the demonstration of the benefit of the combination efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavir

몰타 - 영어 - Medicines Authority

teva b.v. swensweg 5, 2031 ga haarlem, netherlands - tenofovir disoproxil, efavirenz, emtricitabine - film-coated tablet - tenofovir disoproxil 245 mg efavirenz 600 mg emtricitabine 200 mg - antivirals for systemic use

영국 - 영어 - MHRA (Medicines & Healthcare Products Regulatory Agency)

dr reddy's laboratories (uk - efavirenz; tenofovir disoproxil fumarate; emtricitabine - tablet - 600mg ; 245mg ; 200mg

이스라엘 - 영어 - 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 - 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.

말레이시아 - 영어 - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

synerrv sdn bhd - tenofovir disoproxil fumarate; emtricitabine; efavirenz -

이스라엘 - 영어 - 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.

이스라엘 - 영어 - 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.