Izrael - angol - 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.

Egyesült Királyság - angol - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - darunavir ethanolate - tablet - 400mg

Egyesült Királyság - angol - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - darunavir ethanolate - oral suspension - 100mg/1ml

Egyesült Királyság - angol - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - darunavir ethanolate - tablet - 800mg

Európai Unió - angol - EMA (European Medicines Agency)

merck sharp & dohme b.v. - elbasvir, grazoprevir - hepatitis c, chronic - direct acting antivirals, antivirals for systemic use, , antivirals for treatment of hcv infections - zepatier is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4.2, 4.4 and 5.1). for hepatitis c virus (hcv) genotype-specific activity see sections 4.4 and 5.1.,

Izrael - angol - Ministry of Health

j-c health care ltd - cobicistate; darunavir as ethanolate - film coated tablets - cobicistate 150 mg; darunavir as ethanolate 800 mg - darunavir - rezolsta is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv 1) infection in treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions (v11i, v32i, l33f, i47v, i50v, i54l, i54m, t74p, l76v, i84v, l89v).שינוי משטר מינון 2/4/2019pregnancy and postpartumtreatment with rezolsta during pregnancy results in low darunavir exposure (see sections 4.4 and 5.2). therefore, therapy with rezolsta should not be initiated during pregnancy, and women who become pregnant during therapy with rezolsta should be switched to an alternative regimen, see section 4.4 and 4.6. darunavir/ritonavir may be considered as an alternative.

Írország - angol - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - darunavir - film coated tablet - 400 milligram - protease inhibitors

Írország - angol - HPRA (Health Products Regulatory Authority)

wockhardt uk limited - nevirapine anhydrous - tablet - 200 milligram(s) - non-nucleoside reverse transcriptase inhibitors; nevirapine

Egyesült Királyság - angol - MHRA (Medicines & Healthcare Products Regulatory Agency)

mylan - nevirapine - modified-release tablet - 400mg

Málta - angol - Malta Medicines Authority

sandoz pharmaceuticals d.d. verovškova ulica 57, si-1000 ljubljana, slovenia - nevirapine - tablet - nevirapine 200 mg - antivirals for systemic use