Europäische Union - Deutsch - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - mogamulizumab - sezary syndrome; mycosis fungoides - antineoplastische mittel - poteligeo ist indiziert für die behandlung von erwachsenen patienten mit mycosis fungoides (mf) oder sézary-syndrom (ss), die erhalten haben, mindestens eine vorherige systemische therapie.

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

kyowa kirin sàrl - mogamulizumabum - konzentrat zur herstellung einer infusionslösung - mogamulizumabum 20 mg, acidum citricum monohydricum, glycinum, polysorbatum 80, natrii hydroxidum q.s. ad ph, acidum hydrochloricum q.s. ad ph, aqua ad iniectabile ad solutionem pro 5 ml. - poteligeo ist indiziert für die behandlung von erwachsenen patienten mit rezidivierter oder refraktärer mycosis fungoides (mf) oder sézary-syndrome (ss), welche mindestens eine vorherige therapie erhalten haben (siehe abschnitt «klinische wirksamkeit»). - biotechnologika

Europäische Union - Deutsch - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hämoglobinurie, paroxysmal - selektive immunsuppressiva - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

alexion pharma gmbh - ravulizumabum - konzentrat zur herstellung einer infusionslösung - ravulizumabum 300 mg, natrii dihydrogenophosphas, dinatrii phosphas, natrii chloridum, polysorbatum 80, aqua ad iniectabile q.s. ad solutionem pro 30 ml corresp. natrium 115 mg. - paroxysmale nächtliche hämoglobinurie (pnh); atypisches hämolytisch-urämisches syndrom (ahus); generalisierte myasthenia gravis, neuromyelitis-optica-spektrum-erkrankungen (nmosd) - biotechnologika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

alexion pharma gmbh - ravulizumabum - konzentrat zur herstellung einer infusionslösung - ravulizumabum 300 mg, natrii dihydrogenophosphas, dinatrii phosphas, argininum, saccharum, polysorbatum 80, aqua ad iniectabile q.s. ad solutionem pro 3 ml corresp. natrium 4.6 mg. - paroxysmale nächtliche hämoglobinurie (pnh); atypisches hämolytisch-urämisches syndrom (ahus); generalisierte myasthenia gravis, neuromyelitis-optica-spektrum-erkrankungen (nmosd) - biotechnologika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

alexion pharma gmbh - ravulizumabum - konzentrat zur herstellung einer infusionslösung - ravulizumabum 1100 mg, natrii dihydrogenophosphas, dinatrii phosphas, argininum, saccharum, polysorbatum 80, aqua ad iniectabile q.s. ad solutionem pro 11 ml corresp. natrium 16.8 mg. - paroxysmale nächtliche hämoglobinurie (pnh); atypisches hämolytisch-urämisches syndrom (ahus); generalisierte myasthenia gravis, neuromyelitis-optica-spektrum-erkrankungen (nmosd) - biotechnologika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

swedish orphan biovitrum ag - pegcetacoplanum - infusionslösung - pegcetacoplanum 54 mg, sorbitolum 41 mg, acidum aceticum glaciale, natrii acetas trihydricus, natrii hydroxidum, acidum aceticum glaciale, aqua ad iniectabile, ad solutionem pro 1 ml corresp. natrium 0.37 mg. - paroxysmale nächtliche hämoglobinurie (pnh). - synthetika