Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

actavis group ptc ehf. - tenofovirdisoproxil-succinat - filmovertrukne tabletter - 245 mg

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

gilead sciences ireland uc - sofosbuvir, velpatasvir, voxilaprevi - hepatitis c kronisk - antivirale midler til systemisk anvendelse - vosevi is indicated for the treatment of chronic hepatitis c virus (hcv) infection in patients aged 12 years and older and weighing at least 30 kg. (se afsnit 4. 2, 4. 4 og 5.

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

bristol-myers squibb pharma eeig - entecavir - hepatitis b, kronisk - antivirale midler til systemisk anvendelse - baraclude er indiceret til behandling af kronisk hepatitis b virus (hbv) infektion hos voksne med kompenseret leversygdom og dokumentation for aktiv viral replikation, vedvarende forhøjet serum-alanin aminotransferase (alt) niveauer og histologiske dokumentation for aktiv inflammation og/eller fibrose;dekompenseret leversygdom. for både erstatning og dekompenseret leversygdom, denne angivelse er baseret på data fra kliniske forsøg i nukleosid naive patienter med hbeag-positive og hbeag negativ hbv-infektion. med hensyn til patienter med lamivudin-ildfast hepatitis b.

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

mylan pharmaceuticals limited - darunavir - hiv infektioner - antivirale midler til systemisk anvendelse - 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. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):til behandling af hiv-1 infektion i antiretroviral behandling (art)-erfarne voksne patienter, herunder dem, der har været meget forbehandlet. til behandling af hiv-1 infektion hos pædiatriske patienter fra en alder af 3 år og mindst 15 kg kropsvægt. i beslutter at indlede behandling med darunavir co-administreres med en lav dosis ritonavir, forsigtig, bør det overvejes, om den historie behandling af den enkelte patient og de mønstre af mutationer, der er forbundet med forskellige agenter. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 og 5. darunavir co-administreres med en lav dosis ritonavir er indiceret i kombination med andre antiretrovirale lægemidler til behandling af patienter med human immundefekt virus (hiv-1) infektion.  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.  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.  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. i beslutter at indlede behandling med darunavir i en sådan kunst-erfarne patienter, genotypiske test bør vejlede i brugen af darunavir (se afsnit 4. 2, 4. 3, 4. 4 og 5.

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

janssen-cilag international n.v. - telaprevir - hepatitis c kronisk - antivirale midler til systemisk anvendelse - incivo, i kombination med peginterferon alfa og ribavirin, er indiceret til behandling af genotype-1 kronisk hepatitis c hos voksne patienter med kompenseret leversygdom (herunder skrumpelever):der er i behandling naive;som tidligere er blevet behandlet med interferon alfa (pegyleret eller non-pegyleret) alene eller i kombination med ribavirin, herunder relapsers, delvis respondenter og respondenter null.

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

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.

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

teva b.v.  - nevirapin - hiv infektioner - antivirale midler til systemisk anvendelse - nevirapine teva er indiceret i kombination med andre antiretrovirale lægemidler til behandling af hiv 1-inficerede voksne, unge og børn af enhver alder. de fleste af erfaring med nevirapin, er i kombination med nukleosid revers transkriptase hæmmere (nrtis). valget af en efterfølgende behandling efter nevirapin bør være baseret på klinisk erfaring og modstand test.

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

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.

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

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.

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

janssen-cilag international nv - simeprevir - hepatitis c kronisk - antivirale midler til systemisk anvendelse - olysio er indiceret i kombination med andre lægemidler til behandling af kronisk hepatitis c (chc) hos voksne patienter. for at hepatitis c virus (hcv) genotype specifikke aktivitet.