Soliris Uniunea Europeană - română - EMA (European Medicines Agency)

soliris

alexion europe sas - eculizumab - hemoglobinurie, paroxismal - imunosupresoare - soliris este indicat la adulți și copii pentru tratamentul:hemoglobinurie paroxistică nocturnă (hpn). dovezi de beneficii clinice este demonstrată la pacienții cu hemoliză cu simptom clinic(s) indică un grad înalt de activitate a bolii, indiferent de transfuzie istorie (a se vedea secțiunea 5. atipic sindrom hemolitic-uremic (ahus). soliris este indicat la adulți pentru tratamentul:refractare generalizate miastenia gravis (gmg) la pacienții care sunt anti-receptorilor de acetilcolină (achr) anticorpi-pozitiv (a se vedea secțiunea 5. oftalmoneuromielită optica tulburare de spectru (nmosd) la pacienții care sunt anti-aquaporin-4 (aqp4) anticorpi pozitiv cu un curs recurente ale bolii.

NEISVAC-C 0,5 ml România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

neisvac-c 0,5 ml

pfizer manufacturing austria gmbh - austria - vaccin meningococic polizaharidic de grup c - susp. inj. in seringa preumpluta - 0,5ml - vaccinuri bacteriene vaccinuri meningococice

Ultomiris Uniunea Europeană - română - EMA (European Medicines Agency)

ultomiris

alexion europe sas - ravulizumab - hemoglobinurie, paroxismal - imunosupresoare selective - 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.

Aspaveli Uniunea Europeană - română - EMA (European Medicines Agency)

aspaveli

swedish orphan biovitrum ab (publ) - pegcetacoplan - hemoglobinurie, paroxismal - imunosupresoare - 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.