Unione Europea - italiano - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - emoglobinuria, parossistica - immunosoppressori selettivi - 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.

Svizzera - italiano - Swissmedic (Swiss Agency for Therapeutic Products)

alexion pharma gmbh - ravulizumabum - concentrato per soluzione per infusione - 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

Svizzera - italiano - Swissmedic (Swiss Agency for Therapeutic Products)

alexion pharma gmbh - ravulizumabum - concentrato per soluzione per infusione - 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

Svizzera - italiano - Swissmedic (Swiss Agency for Therapeutic Products)

alexion pharma gmbh - ravulizumabum - concentrato per soluzione per infusione - 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

Svizzera - italiano - Swissmedic (Swiss Agency for Therapeutic Products)

swedish orphan biovitrum ag - pegcetacoplanum - soluzione per infusione - 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

Svizzera - italiano - Swissmedic (Swiss Agency for Therapeutic Products)

alexion pharma gmbh - danicopanum - compresse rivestite con film - filmtablette 50 mg: danicopanum 50 mg, hypromellosi acetas succinas, lactosum monohydricum 60.5 mg, cellulosum microcristallinum, carmellosum natricum conexum, natrii laurilsulfas, silica colloidalis anhydrica, magnesii stearas, Überzug: poly(alcohol vinylicus), e 171, macrogolum 3350, talcum, pro compresso obducto corresp. natrium max. 1.22 mg. filmtablette 100 mg: danicopanum 100 mg, hypromellosi acetas succinas, lactosum monohydricum 121 mg, cellulosum microcristallinum, carmellosum natricum conexum, natrii laurilsulfas, silica colloidalis anhydrica, magnesii stearas, Überzug: poly(alcohol vinylicus), e 171, macrogolum 3350, talcum, pro compresso obducto corresp. natrium max. 2.44 mg. - als zusatztherapie zu ravulizumab oder eculizumab zur behandlung bei klinisch relevanter extravaskulärer hämolyse nach mindestens 6-monatiger monotherapie mit einem c5-inhibitor bei erwachsenen patienten mit paroxysmaler nächtlicher hämoglobinurie - synthetika

Svizzera - italiano - Swissmedic (Swiss Agency for Therapeutic Products)

alexion pharma gmbh - danicopanum - compresse rivestite con film - danicopanum 100 mg, hypromellosi acetas succinas, lactosum monohydricum 121 mg, cellulosum microcristallinum, carmellosum natricum conexum, natrii laurilsulfas, silica colloidalis anhydrica, magnesii stearas, Überzug: poly(alcohol vinylicus), e 171, macrogolum 3350, talcum, pro compresso obducto corresp. natrium max. 2.44 mg. - als zusatztherapie zu ravulizumab oder eculizumab zur behandlung bei klinisch relevanter extravaskulärer hämolyse nach mindestens 6-monatiger monotherapie mit einem c5-inhibitor bei erwachsenen patienten mit paroxysmaler nächtlicher hämoglobinurie - synthetika

Unione Europea - italiano - EMA (European Medicines Agency)

elan pharma international ltd. - natalizumab - malattia di crohn - immunostimolanti, - il trattamento di moderata a grave malattia di crohn attiva per la riduzione dei segni e dei sintomi, e l'induzione e il mantenimento protratto di risposta e di remissione, in pazienti che non abbiano risposto nonostante un completo e adeguato corso di terapia con corticosteroidi e immunosoppressori; o che sono intolleranti o hanno controindicazioni a tali terapie.

Svizzera - italiano - Swissmedic (Swiss Agency for Therapeutic Products)

biogen switzerland ag - natalizumabum - concentrato per soluzione per infusione - natalizumabum 300 mg, natrii dihydrogenophosphas monohydricus, dinatrii phosphas heptahydricus, natrii chloridum, polysorbatum 80, aqua ad iniectabile q.s. ad solutionem pro 15 ml corresp. natrium 52 mg. - multiple sklerose - biotechnologika

Unione Europea - italiano - EMA (European Medicines Agency)

biogen idec ltd - daclizumab - sclerosi multipla - immunosoppressori - zinbryta è indicato nei pazienti adulti per il trattamento di forme recidivanti di sclerosi multipla (rms).