Umoja wa Ulaya - Kislovenia - EMA (European Medicines Agency)

samsung bioepis nl b.v. - eculizumab - hemoglobinurija, paroksizmal - 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.

Slovenia - Kislovenia - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

pfizer luxembourg sarl - tetanusni toksoid; polisaharid (de-o-acetiliran) neisseriae meningitidis tip c (sev c11), vezan - suspenzija za injiciranje - tetanusni toksoid 20 µg / 0,5 ml  polisaharid (de-o-acetiliran) neisseriae meningitidis tip c (sev c11), vezan10 µg / 0,5 ml; polisaharid (de-o-acetiliran) neisseriae meningitidis tip c (sev c11), vezan 10 µg / 0,5 ml - cepivo proti meningokokom tipa c s prečiščenimi in vezanimi polisaharidnimi antigeni

Umoja wa Ulaya - Kislovenia - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinurija, paroksizmal - 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.