Ευρωπαϊκή Ένωση - Ιταλικά - EMA (European Medicines Agency)

amgen technology (ireland) uc - eculizumab - emoglobinuria, parossistica - immunosoppressori - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). evidenza di beneficio clinico è dimostrato che, in pazienti con emolisi con sintomo clinico(s) indicativa di alta attività di malattia, a prescindere dalla trasfusione di storia (vedere la sezione 5.

Ευρωπαϊκή Ένωση - Ιταλικά - EMA (European Medicines Agency)

alexion europe sas - eculizumab - emoglobinuria, parossistica - immunosoppressori - soliris è indicato negli adulti e nei bambini per il trattamento di:parossistica notturna haemoglobinuria (pnh). evidenza di beneficio clinico è dimostrato che, in pazienti con emolisi con sintomo clinico(s) indicativa di alta attività di malattia, a prescindere dalla trasfusione di storia (vedere la sezione 5. la sindrome emolitico-uremica atipica (ahus). soliris è indicato negli adulti per il trattamento di:refrattari generalizzata miastenia gravis (gmg) in pazienti che sono anti-recettore dell'acetilcolina (achr) anticorpo-positivi (vedere la sezione 5. la neuromielite ottica di disturbo dello spettro (nmosd) in pazienti che sono anti-acquaporina-4 (aqp4) anticorpo-positivi con una ricaduta corso della malattia.

Ευρωπαϊκή Ένωση - Ιταλικά - 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.

Ελβετία - Ιταλικά - Swissmedic (Swiss Agency for Therapeutic Products)

alexion pharma gmbh - eculizumabum - concentrato per soluzione per infusione - eculizumabum 300 mg, natrii dihydrogenophosphas monohydricus, dinatrii phosphas heptahydricus, natrii chloridum, polysorbatum 80, aqua ad iniectabile q.s. ad solutionem pro 30 ml corresp. natrium 115 mg. - paroxysmale nächtliche hämoglobinurie. atypisches hämolytisch-urämisches syndrom. refraktäre generalisierte myasthenia gravis.; behandlung erwachsener mit neuromyelitis-optica-spektrumerkrankungen (nmosd) - biotechnologika

Ευρωπαϊκή Ένωση - Ιταλικά - 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.

Ελβετία - Ιταλικά - 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

Ελβετία - Ιταλικά - 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

Ελβετία - Ιταλικά - 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

Ευρωπαϊκή Ένωση - Ιταλικά - 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.

Ιταλία - Ιταλικά - AIFA (Agenzia Italiana del Farmaco)

glaxosmithkline vaccines s.r.l. - antigene del meningococcus c, polisaccaridico purificato - antigene del meningococcus c, polisaccaridico purificato