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)

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)

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)

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.

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

gsk vaccines s.r.l. - ydre membran vesikler fra neisseria meningitidis gruppe b (stamme nz 98/254), rekombinant neisseria meningitidis gruppe b fhbp fusion protein, rekombinant neisseria meningitidis gruppe b nada protein, rekombinant neisseria meningitidis gruppe b nhba fusion protein - meningitis, meningokok - meningokokvacciner - aktiv immunisering mod invasiv sygdom forårsaget af neisseria meningitidis serogruppe b-stammer.

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

gsk vaccines s.r.l. - meningokokgruppe a, c, w-135 og y-konjugatvaccine - immunization; meningitis, meningococcal - bakterievacciner - vialsmenveo er indiceret til aktiv immunisering af børn (fra to år), unge og voksne risiko for eksponering for neisseria meningitidis gruppe a, c, w135 og y, for at forhindre, at invasive sygdom. brug af denne vaccine bør være i overensstemmelse med de officielle anbefalinger.

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

pfizer europe ma eeig - neisseria meningitidis serogruppe b fhbp (rekombinant lipideret fhbp (faktor h bindende protein)) subfamilie a; neisseria meningitidis serogruppe b fhbp (rekombinant lipideret fhbp (faktor h bindende protein)) subfamilie b - meningitis, meningokok - bacterial vaccines, meningococcal vaccines - trumenba er indiceret til aktiv immunisering af individer 10 år og ældre for at forhindre invasiv meningokok sygdom forårsaget af neisseria meningitidis serogruppe b. brug af denne vaccine bør være i overensstemmelse med de officielle anbefalinger.

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

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - immunosuppressiva - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.

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

pfizer europe ma eeig - neisseria meningitidis group a polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group c polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group w-135 polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group y polysaccharide conjugated to tetanus toxoid - meningitis, meningokok - vacciner - nimenrix er indiceret til aktiv immunisering af personer fra 6 uger mod invasive meningokoksygdomme forårsaget af neisseria meningitidis gruppe a, c, w-135 og y.