Vācija - vācu - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

tillomed pharma gmbh (8132043) - darunavir - filmtablette - 400 mg - teil 1 - filmtablette; darunavir (32142) 400 milligramm

Eiropas Savienība - vācu - EMA (European Medicines Agency)

janssen-cilag international n.v. - darunavir, cobicistat - hiv-infektionen - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - rezolsta ist in kombination mit anderen antiretroviralen arzneimitteln zur behandlung der infektion mit dem humanen immundefizienzvirus 1 (hiv 1) bei erwachsenen ab 18 jahren indiziert. genotypische tests sollten als richtschnur für die verwendung von rezolsta.

Eiropas Savienība - vācu - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - hiv-infektionen - antivirale mittel zur systemischen anwendung - 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.

Vācija - vācu - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

tad pharma gmbh (3044021) - darunavir - filmtablette - teil 1 - filmtablette; darunavir (32142) 600 milligramm

Eiropas Savienība - vācu - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir, cobicistat, emtricitabin, tenofovir alafenamide - hiv-infektionen - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - symtuza ist indiziert zur behandlung der infektion mit dem humanen immundefizienzvirus typ 1 (hiv-1) bei erwachsenen und jugendlichen (ab 12 jahren mit einem körpergewicht von mindestens 40 kg).. genotypic testing should guide the use of symtuza.

Šveice - vācu - Swissmedic (Swiss Agency for Therapeutic Products)

viatris pharma gmbh - darunavirum - tabletten - darunavirum 400 mg ut darunavirum ethanolum, silica colloidalis anhydrica, cellulosum microcristallinum, crospovidonum, carboxymethylamylum natricum a, hypromellosum, magnesii stearas, Überzug: poly(alcohol vinylicus), e 171, macrogolum 3350, talcum, pro compresso obducto corresp. natrium 4.33 mg. - hiv-infektion - synthetika

Šveice - vācu - Swissmedic (Swiss Agency for Therapeutic Products)

viatris pharma gmbh - darunavirum - tabletten - darunavirum 600 mg ut darunavirum ethanolum, silica colloidalis anhydrica, cellulosum microcristallinum, crospovidonum, carboxymethylamylum natricum a, hypromellosum, magnesii stearas, Überzug: poly(alcohol vinylicus), e 171, macrogolum 3350, talcum, pro compresso obducto corresp. natrium 6.5 mg. - hiv-infektion - synthetika

Šveice - vācu - Swissmedic (Swiss Agency for Therapeutic Products)

viatris pharma gmbh - darunavirum - tabletten - darunavirum 800 mg ut darunavirum ethanolum, silica colloidalis anhydrica, cellulosum microcristallinum, crospovidonum, carboxymethylamylum natricum a, hypromellosum, magnesii stearas, Überzug: poly(alcohol vinylicus), e 171, macrogolum 3350, talcum, pro compresso obducto corresp. natrium 3.65 mg. - hiv-infektion - synthetika

Austrija - vācu - AGES (Agentur für Gesundheit und Ernährungssicherheit)

sandoz gmbh - darunavir -

Šveice - vācu - Swissmedic (Swiss Agency for Therapeutic Products)

mepha pharma ag - darunavirum - lactabs - darunavirum 400 mg, excipiens pro compresso dunst. - hiv-infektionen - synthetika