Den Europæiske Union - dansk - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuri, paroxysmal - selektive immunosuppressiva - 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.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

alexion europe sas - eculizumab - hemoglobinuri, paroxysmal - immunosuppressiva - soliris er indiceret hos voksne og børn til behandling af:paroksysmal natlig haemoglobinuria (pnh). dokumentation af klinisk fordel er påvist hos patienter med haemolysis med klinisk symptom(er) betegnende for høj sygdomsaktivitet, uanset transfusion historie (se afsnit 5. atypiske hæmolytisk uræmisk syndrom (ahus). soliris er indiceret hos voksne til behandling af:ildfaste generaliseret myasthenia gravis (gmg) i patienter, der er anti-acetylcholin-receptor (achr) antistof-positive (se afsnit 5. neuromyelitis optica spektrum forstyrrelse (nmosd) i patienter, der er anti-aquaporin-4 (aqp4) antistof-positive med en recidiverende forløbet af sygdommen.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

samsung bioepis nl b.v. - eculizumab - hemoglobinuri, paroxysmal - immunosuppressiva - 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.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

amgen technology (ireland) uc - eculizumab - hemoglobinuri, paroxysmal - immunosuppressiva - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). dokumentation af klinisk fordel er påvist hos patienter med haemolysis med klinisk symptom(er) betegnende for høj sygdomsaktivitet, uanset transfusion historie (se afsnit 5.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - pegcetacoplan - hemoglobinuri, paroxysmal - immunosuppressiva - 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.

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

hexal a/s - ciprofloxacin - filmovertrukne tabletter - 250 mg

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

actavis group ptc ehf. - ciprofloxacinhydrochlorid, vandfrit - filmovertrukne tabletter - 250 mg

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

krka sverige ab - ciprofloxacinhydrochlorid (monohydrat) - filmovertrukne tabletter - 250 mg

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

orion corporation - ciprofloxacinhydrochlorid (monohydrat) - filmovertrukne tabletter - 250 mg

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

sandoz a/s - ciprofloxacinhydrochlorid, vandfrit - filmovertrukne tabletter - 250 mg