Europäische Union - Deutsch - EMA (European Medicines Agency)

samsung bioepis nl b.v. - eculizumab - hämoglobinurie, paroxysmal - immunsuppressiva - 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.

Europäische Union - Deutsch - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hämoglobinurie, paroxysmal - selektive immunsuppressiva - 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.

Europäische Union - Deutsch - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - pegcetacoplan - hämoglobinurie, paroxysmal - immunsuppressiva - 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.

Europäische Union - Deutsch - EMA (European Medicines Agency)

leo pharma a/s - brodalumab - psoriasis - immunsuppressiva - kyntheum ist indiziert zur behandlung von mittelschwerer bis schwerer plaque-psoriasis bei erwachsenen patienten, die kandidaten für eine systemische therapie sind.

Europäische Union - Deutsch - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - risankizumab - psoriasis; arthritis, psoriatic - immunsuppressiva - plaque psoriasisskyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. psoriatic arthritisskyrizi, alone or in combination with methotrexate (mtx), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (dmards). crohn's diseaseskyrizi is indicated for the treatment of adult patients with moderately to severely active crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

Europäische Union - Deutsch - EMA (European Medicines Agency)

ucb pharma s.a.   - bimekizumab - psoriasis - immunsuppressiva - plaque psoriasisbimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. psoriatic arthritisbimzelx, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (dmards). axial spondyloarthritisnon-radiographic axial spondyloarthritis (nr-axspa)bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (nsaids). ankylosing spondylitis (as, radiographic axial spondyloarthritis)bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.

Europäische Union - Deutsch - EMA (European Medicines Agency)

gsk vaccines s.r.l. - äußere-membran-vesikel von neisseria meningitidis der gruppe b (stamm nz 98/254), rekombinante neisseria meningitidis der gruppe b fhbp-fusionsprotein rekombinantes neisseria meningitidis der gruppe b nada-protein, rekombinant neisseria meningitidis der gruppe b nhba-fusionsprotein - meningitis, meningokokken - meningokokken-impfstoffe - aktive immunisierung gegen invasive erkrankungen, die durch neisseria meningitidis-serogruppe-b-stämme verursacht werden.

Europäische Union - Deutsch - EMA (European Medicines Agency)

gsk vaccines s.r.l. - meningokokkengruppe a, c, w-135 und y konjugat-impfstoff - immunization; meningitis, meningococcal - bakterielle impfstoffe - vialsmenveo ist indiziert für die aktive immunisierung von kindern (ab zwei jahren), jugendlichen und erwachsenen mit einem risiko der exposition gegenüber neisseria meningitidis der gruppen a, c, w135 und y, um zu verhindern, dass invasive erkrankung. der einsatz dieses impfstoffs sollte in übereinstimmung mit den offiziellen empfehlungen.

Europäische Union - Deutsch - EMA (European Medicines Agency)

pfizer europe ma eeig - neisseria meningitidis serogruppe b fhbp (rekombinantes lipidiertes fhbp (faktor h-bindendes protein)) unterfamilie a; neisseria meningitidis serogruppe b fhbp (rekombinantes lipidiertes fhbp (faktor h-bindendes protein)) unterfamilie b - meningitis, meningokokken - bacterial vaccines, meningococcal vaccines - trumenba ist indiziert zur aktiven immunisierung von personen im alter von 10 jahren und älter, um invasive meningokokken-erkrankungen, die durch neisseria meningitidis serogruppe b verursacht werden, zu verhindern. der einsatz dieses impfstoffs sollte in übereinstimmung mit den offiziellen empfehlungen.

Deutschland - Deutsch - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

european pharma b.v. (8146789) - meningokokken-gruppe-c-oligosaccharid-diphtherie-crm197-protein-konjugat - injektionssuspension - teil 1 - injektionssuspension; meningokokken-gruppe-c-oligosaccharid-diphtherie-crm197-protein-konjugat (30996) 22,5 mikrogramm