瑞士 - 意大利文 - Swissmedic (Swiss Agency for Therapeutic Products)

teva pharma ag - reslizumabum - concentrato per soluzione per infusione - reslizumabum 100 mg, saccharum, natrii acetas trihydricus, acidum aceticum glaciale, aqua ad iniectabile q.s. ad solutionem pro 10 ml corresp. natrium 1.41 mg. - aggiuntiva in caso di grave eosinophilem asma negli adulti - biotechnologika

瑞士 - 意大利文 - Swissmedic (Swiss Agency for Therapeutic Products)

teva pharma ag - reslizumabum - concentrato per soluzione per infusione - reslizumabum 25 mg, saccharum, natrii acetas trihydricus, acidum aceticum glaciale, aqua ad iniectabile q.s. ad solutionem pro 2.5 ml corresp. natrium 0.35 mg. - aggiuntiva in caso di grave eosinophilem asma negli adulti - biotechnologika

欧盟 - 意大利文 - EMA (European Medicines Agency)

samsung bioepis nl b.v. - eculizumab - emoglobinuria, parossistica - immunosoppressori - epysqli is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history.

欧盟 - 意大利文 - 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.

瑞士 - 意大利文 - 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

瑞士 - 意大利文 - 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

意大利 - 意大利文 - AIFA (Agenzia Italiana del Farmaco)

roche spa - daclizumab - preparazione iniettabile - 5 mg/ml concentrato per soluzione per infusione 1 flacone 5 ml iv

欧盟 - 意大利文 - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - pegcetacoplan - emoglobinuria, parossistica - immunosoppressori - aspaveli is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh) who are anaemic after treatment with a c5 inhibitor for at least 3 months.

瑞士 - 意大利文 - Swissmedic (Swiss Agency for Therapeutic Products)

novartis pharma schweiz ag - ofatumumabum - soluzione iniettabile in siringa preriempita - ofatumumabum 20 mg, argininum, natrii acetas trihydricus, natrii chloridum, polysorbatum 80, dinatrii edetas, acidum hydrochloridum 25 per centum, aqua ad iniectabile q.s. ad solutionem pro 0.4 ml corresp. natrium 0.92 mg. - multiple sklerose - biotechnologika

瑞士 - 意大利文 - Swissmedic (Swiss Agency for Therapeutic Products)

novartis pharma schweiz ag - ofatumumabum - soluzione iniettabile in penna preriempita - ofatumumabum 20 mg, argininum, natrii acetas trihydricus, natrii chloridum, polysorbatum 80, dinatrii edetas, acidum hydrochloridum 25 per centum, aqua ad iniectabile q.s. ad solutionem pro 0.4 ml corresp. natrium 0.92 mg. - multiple sklerose - biotechnologika