Evotaz Den Europæiske Union - dansk - EMA (European Medicines Agency)

evotaz

bristol-myers squibb pharma eeig - cobicistat, atazanavir - hiv infektioner - antivirale midler til systemisk anvendelse - evotaz is indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1 infected adults and adolescents (aged 12 years and older weighing at least 35 kg) without known mutations associated with resistance to atazanavir (see sections 4. 4 og 5.

Tybost Den Europæiske Union - dansk - EMA (European Medicines Agency)

tybost

gilead sciences ireland uc - cobicistat - hiv infektioner - antivirale midler til systemisk anvendelse - tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (hiv-1) infected adults and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir.

Intelence Den Europæiske Union - dansk - EMA (European Medicines Agency)

intelence

janssen-cilag international nv - etravirine - hiv infektioner - non-nucleoside reverse transcriptase inhibitors, antivirals for systemic use - intelence, i kombination med en boostet protease hæmmer og andre antiretrovirale lægemidler, er indiceret til behandling af menneske-immundefekt-virus-type-1 (hiv-1) infektion i antiretroviral behandling-erfarne voksne patienter og i antiretroviral behandling-erfarne pædiatriske patienter fra seks år. denne angivelse er baseret på uge-48 analyser fra to-fase-iii-forsøg i meget forbehandles patienter, hvor intelence blev undersøgt i kombination med en optimeret baggrund regime (obr), der indeholdt darunavir/ritonavir. angivelsen i pædiatriske patienter, der er baseret på 48-uge analyser af en enkelt-arm -, fase-ii-forsøg i antiretroviral-behandling-erfarne pædiatriske patienter.

Daklinza Den Europæiske Union - dansk - EMA (European Medicines Agency)

daklinza

bristol-myers squibb pharma eeig - daclatasvir dihydrochlorid - hepatitis c kronisk - antivirale midler til systemisk anvendelse - daklinza er indiceret i kombination med andre lægemidler til behandling af kronisk hepatitis c virus (hcv) infektion hos voksne (se afsnit 4. 2, 4. 4 og 5. for hcv-genotype specifik aktivitet, se afsnit 4. 4 og 5.

Stribild Den Europæiske Union - dansk - EMA (European Medicines Agency)

stribild

gilead sciences ireland uc - elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate - hiv infektioner - antivirals for treatment of hiv infections, combinations, antivirals for systemic use - behandling af human immundefekt virus 1 (hiv 1) infektion hos voksne i alderen 18 år og over hvem antiretroviral behandling-naive eller er smittet med hiv 1 uden kendte mutationer i forbindelse med modstand mod nogen af de tre antiretroviral agenter i stribild.

Rezolsta Den Europæiske Union - dansk - EMA (European Medicines Agency)

rezolsta

janssen-cilag international n.v. - darunavir, cobicistat - hiv infektioner - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - rezolsta, er indiceret i kombination med andre antiretrovirale lægemidler til behandling af human immunodeficiency virus 1 (hiv 1) infektion hos voksne i alderen 18 år eller derover. genotypiske test bør vejlede i brugen af rezolsta.

Symtuza Den Europæiske Union - dansk - EMA (European Medicines Agency)

symtuza

janssen-cilag international nv - darunavir, cobicistat, emtricitabine, tenofovir alafenamide - hiv infektioner - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - symtuza er indiceret til behandling af infektion med human immunodeficiency virus type 1 (hiv-1) hos voksne og unge (i alderen 12 år og ældre med kropsvægt mindst 40 kg). genotypic testing should guide the use of symtuza.

Genvoya Den Europæiske Union - dansk - EMA (European Medicines Agency)

genvoya

gilead sciences ireland uc - elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide - hiv infektioner - antivirale midler til systemisk anvendelse - genvoya er indiceret til behandling af voksne og unge (alderen 12 år og ældre med kroppen vægt mindst 35 kg) inficeret med human immundefekt virus 1 (hiv 1) uden nogen kendt mutationer i forbindelse med modstand mod integrase inhibitor klasse, emtricitabine eller tenofovir.

Sunlenca Den Europæiske Union - dansk - EMA (European Medicines Agency)

sunlenca

gilead sciences ireland unlimited company - lenacapavir sodium - hiv infektioner - antivirale midler til systemisk anvendelse - sunlenca injection, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant hiv 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen (see sections 4. 2 og 5. sunlenca tablet, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant hiv 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen, for oral loading prior to administration of long-acting lenacapavir injection (see sections 4. 2 og 5.

Prezista Den Europæiske Union - dansk - EMA (European Medicines Agency)

prezista

janssen-cilag international nv - darunavir - hiv infektioner - antivirale midler til systemisk anvendelse - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, 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). in deciding to initiate treatment with prezista co administered with cobicistat or 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 prezista. prezista, 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. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens: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 prezista 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 prezista. prezista, 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. prezista, 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). prezista 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. 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 prezista in such art experienced patients, genotypic testing should guide the use of prezista.