Ingilterra - Ingliż - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - etravirine - tablet - 25mg

Iżrael - Ingliż - Ministry of Health

gilead sciences israel ltd - cobicistate; elvitegravir; emtricitabine; tenofovir alafenamide - film coated tablets - tenofovir alafenamide 10 mg; emtricitabine 200 mg; cobicistate 150 mg; elvitegravir 150 mg - emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat - gendevra is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows:• in adults and adolescents aged from 12 years and with body weight at least 35 kg• in children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities.תוספת התוויה: 2/7/2019addition of new info to posology section: precaution in pregnant women

Iżrael - Ingliż - Ministry of Health

gilead sciences israel ltd - cobicistate; elvitegravir; emtricitabine; tenofovir alafenamide - film coated tablets - tenofovir alafenamide 10 mg; emtricitabine 200 mg; cobicistate 150 mg; elvitegravir 150 mg - emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat - gendevra is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows:• in adults and adolescents aged from 12 years and with body weight at least 35 kg• in children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities.תוספת התוויה: 2/7/2019addition of new info to posology section: precaution in pregnant women

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - hiv infections - antivirals for systemic use - darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection (see section 4.2).darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4.2):for the treatment of hiv-1 infection in antiretroviral treatment (art)-experienced adult patients, including those that have been highly pre-treated.for the treatment of hiv-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.in deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4.2, 4.4 and 5.1).darunavir co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection. darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.2). darunavir mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (art)-naïve (see section 4.2). art-experienced with no darunavir resistance associated mutations (drv-rams) and who have plasma hiv-1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 10⁶/l. in deciding to initiate treatment with darunavir in such art-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).

Għarabja Sawdita - Ingliż - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

gilead sciences limited (cork), ireland - cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide - film-coated tablet - 10, 150, 200, 150 mg

Bangladexx - Ingliż - DGDA (Directorate General of Drug Administration)

delta pharma limited - cobicistat + darunavir - tablet - 150 mg + 800 mg

Bangladexx - Ingliż - DGDA (Directorate General of Drug Administration)

opsonin pharma limited - cobicistat + darunavir - tablet - 150 mg + 800 mg

Bangladexx - Ingliż - DGDA (Directorate General of Drug Administration)

radiant pharmaceuticals ltd. - cobicistat + darunavir - tablet - 150 mg + 800 mg

Bangladexx - Ingliż - DGDA (Directorate General of Drug Administration)

the acme laboratories ltd. - cobicistat + darunavir - tablet - 150 mg + 800 mg

Iżrael - Ingliż - 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.