Եվրոպական Միություն - գերմաներեն - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - hiv-infektionen - antivirale mittel zur systemischen anwendung - 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):für die behandlung von hiv-1-infektion eine antiretrovirale behandlung (art)-erfahrenen erwachsenen patienten, einschließlich derer, die stark vorbehandelt. für die behandlung von hiv-1-infektion bei pädiatrischen patienten ab dem alter von 3 jahren und mindestens 15 kg körpergewicht. bei der entscheidung über die einleitung der behandlung mit darunavir co-verabreicht mit niedrig dosiertem ritonavir, sollte besondere beachtung geschenkt werden, um die behandlung der geschichte der einzelnen patienten und das muster der mutationen im zusammenhang mit anderen agenten. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 und 5. darunavir co-verabreicht mit niedrig dosiertem ritonavir ist angezeigt in kombination mit anderen antiretroviralen arzneimitteln für die behandlung von patienten mit humanen immundefizienz-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. bei der entscheidung über die einleitung der behandlung mit darunavir in einer solchen art-erfahrenen patienten, genotypische tests sollten als richtschnur für die verwendung von darunavir (siehe abschnitte 4. 2, 4. 3, 4. 4 und 5.

Եվրոպական Միություն - գերմաներեն - EMA (European Medicines Agency)

instituto grifols s.a. - human normal immunoglobulin - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - immunseren und immunglobuline, - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.

Եվրոպական Միություն - գերմաներեն - 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.

Եվրոպական Միություն - գերմաներեն - EMA (European Medicines Agency)

cheplapharm arzneimittel gmbh - orlistat - fettleibigkeit - anti-fett-präparate, exkl. diät-produkte - xenical ist in verbindung mit einer leicht kalorienreduzierten diät zur behandlung von adipösen patienten mit einem body mass index (bmi) größer oder gleich 30 kg/m2 oder übergewichtigen patienten (bmi > 28 kg/m2) mit damit verbundenen risikofaktoren angegeben.. die behandlung mit orlistat sollte nach 12 wochen abgebrochen werden, wenn die patienten nicht in der lage gewesen, zu verlieren mindestens 5% des körpergewichts gemessen an den start der therapie.

Եվրոպական Միություն - գերմաներեն - EMA (European Medicines Agency)

eli lilly nederland b.v. - tirzepatide - diabetes mellitus, typ 2 - drogen bei diabetes verwendet - mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications- in addition to other medicinal products for the treatment of diabetes. for study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4. 4, 4. 5 und 5.

Շվեյցարիա - գերմաներեն - Swissmedic (Swiss Agency for Therapeutic Products)

bayer (schweiz) ag - ethinylestradiolum, cyproteroni acetas - dragees - ethinylestradiolum 35 µg, cyproteroni acetas 2 mg, lactosum monohydricum 31.115 mg, maydis amylum, povidonum k 25, talcum, magnesii stearas, Überzug: saccharum 19.371 mg, povidonum k 90, macrogolum 6000, calcii carbonas, talcum, glycerolum (85 per centum), cera montana, e 171, e 172 (flavum), pro compresso. - androgenisierungserscheinungen - synthetika

Շվեյցարիա - գերմաներեն - Swissmedic (Swiss Agency for Therapeutic Products)

berlis ag - ethinylestradiolum, cyproteroni acetas - dragees - ethinylestradiolum 35 µg, cyproteroni acetas 2 mg, lactosum monohydricum 31.115 mg, maydis amylum, povidonum k 25, talcum, magnesii stearas, Überzug: saccharum 19.371 mg, povidonum k 90, macrogolum 6000, calcii carbonas, talcum, glycerolum (85 per centum), cera montana, e 171, e 172 (flavum), pro compresso. - androgenisierungserscheinungen - synthetika

Շվեյցարիա - գերմաներեն - Swissmedic (Swiss Agency for Therapeutic Products)

stragen pharma sa - cyproteroni acetas, ethinylestradiolum - dragees - cyproteroni acetas 2 mg, ethinylestradiolum 0.035 mg, lactosum monohydricum 31.115 mg, maydis amylum, povidonum k 25, magnesii stearas, talcum, pellicule: talcum, saccharum 19.637 mg, calcii carbonas, macrogolum 6000, e 171, povidonum k 90, glycerolum (85 per centum), cera montanglycoli, pro compresso obducto. - veranstaltungen hyperandrogénie - synthetika

Շվեյցարիա - գերմաներեն - Swissmedic (Swiss Agency for Therapeutic Products)

mepha pharma ag - ethinylestradiolum, cyproteroni acetas - dragees - ethinylestradiolum 35 µg, cyproteroni acetas 2 mg, lactosum monohydricum 41.19 mg, cellulosum microcristallinum, povidonum k 30, carmellosum natricum conexum corresp. natrium 0.016 mm, magnesii stearas, Überzug: hypromellosum, e 171, macrogolum 400, e 132, e 172 (flavum), e 172 (nigrum), e 172 (rubrum), e 104, lacca, cera alba, cera carnauba, saccharum 10.36 mg, pro compresso obducto. - androgenisierungserscheinungen - synthetika

Շվեյցարիա - գերմաներեն - Swissmedic (Swiss Agency for Therapeutic Products)

sandoz pharmaceuticals ag - ethinylestradiolum, cyproteroni acetas - dragees - ethinylestradiolum 35 µg, cyproteroni acetas 2 mg, color.: e 104, e 132, excipiens pro compresso dunst. - androgenisierungserscheinungen - synthetika