Ευρωπαϊκή Ένωση - Κροατικά - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuria, paroxysmal - selektivni imunosupresivi - 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.

Ευρωπαϊκή Ένωση - Κροατικά - EMA (European Medicines Agency)

samsung bioepis nl b.v. - Экулизумаб - hemoglobinuria, paroxysmal - imunosupresivi - 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.

Ευρωπαϊκή Ένωση - Κροατικά - EMA (European Medicines Agency)

amgen technology (ireland) uc - Экулизумаб - hemoglobinuria, paroxysmal - imunosupresivi - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). dokaza klinički učinak očituje se u bolesnika s гемолизом s klinički simptom(ova), ukazuje na visoke aktivnosti bolesti, bez obzira na priče transfuziju (vidi odjeljak 5.

Ευρωπαϊκή Ένωση - Κροατικά - EMA (European Medicines Agency)

alexion europe sas - Экулизумаб - hemoglobinuria, paroxysmal - imunosupresivi - Солирис indiciran za odrasle i djecu, za liječenje:пароксизмальная noćni гемоглобинурия (apg). dokaza klinički učinak očituje se u bolesnika s гемолизом s klinički simptom(ova), ukazuje na visoke aktivnosti bolesti, bez obzira na priče transfuziju (vidi odjeljak 5. Атипичный гемолитико-уремический (agus). Солирис prikazan kod odraslih za liječenje:vatrostalne postati generalizirani миастенией gravis (ГГМ) u bolesnika s anti-ацетилхолиновому рецептору (АЧР) antitijela (vidi odjeljak 5. poremećaj neuromyelitis vidnog spektra (nmosd) kod pacijenata koji su anti-aquaporin-4 (aqp4) antitijela s recidivom tijekom bolesti.

Μαυροβούνιο - Κροατικά - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

druŠtvo za trgovinu na veliko farmaceutskim proizvodima "glosarij" d.o.o.-podgorica - ravulizumab - koncentrat za rastvor za infuziju - 1100mg/11 ml

Μαυροβούνιο - Κροατικά - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

druŠtvo za trgovinu na veliko farmaceutskim proizvodima "glosarij" d.o.o.-podgorica - ravulizumab - koncentrat za rastvor za infuziju - 300mg/3ml

Μαυροβούνιο - Κροατικά - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

druŠtvo za trgovinu na veliko farmaceutskim proizvodima "glosarij" d.o.o.-podgorica - ravulizumab - koncentrat za rastvor za infuziju - 300mg/30ml

Βοσνία - Ερζεγοβίνη - Κροατικά - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

amicus pharma d.o.o. - ravulizumab - koncentrat za otopinu za infuziju - 300 mg/3 ml - 1 bočica sa 3 ml koncentrata za otopinu za infuziju sadrži 300 mg ravulizumaba (100 mg/ml)

Βοσνία - Ερζεγοβίνη - Κροατικά - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

amicus pharma d.o.o. - ravulizumab - koncentrat za otopinu za infuziju - 1100 mg/11 ml - 1 bočica sa 11 ml koncentrata za otopinu za infuziju sadrži 1100 mg ravulizumaba (100 mg/ml)

Βοσνία - Ερζεγοβίνη - Κροατικά - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

amicus pharma d.o.o. - ravulizumab - koncentrat za otopinu za infuziju - 300 mg/30 ml - 1 bočica sa 30 ml koncentrata za otopinu za infuziju sadrži 300 mg ravulizumaba (10 mg/ml)