Aspaveli Unió Europea - islandès - EMA (European Medicines Agency)

aspaveli

swedish orphan biovitrum ab (publ) - pegcetacoplan - blóðrauði, ofsakláði - Ónæmisbælandi lyf - 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.

Menveo Unió Europea - islandès - EMA (European Medicines Agency)

menveo

gsk vaccines s.r.l. - meningókokka hóp a, c, w-135 og y samtengd bóluefni - immunization; meningitis, meningococcal - bakteríubóluefni - vialsmenveo er ætlað fyrir virk bólusetningar sem börn (frá tveggja ára aldri), unglingum og fullorðnir í hættu af völdum neisseria meningitidis tekur, c, w135 og y, til að koma í veg fyrir innrásar sjúkdómur. notkun þetta bóluefni ætti að vera í samræmi við opinbera tillögur.

Bexsero Unió Europea - islandès - EMA (European Medicines Agency)

bexsero

gsk vaccines s.r.l. - ytri himnu frá neisseria meningitidis hópur b (álag nýja-sjáland 98/254), skal læknir hafa neisseria meningitidis hópur b fhbp samruna prótín, skal læknir hafa neisseria meningitidis hópur b nada prótín, skal læknir hafa neisseria meningitidis hópur b nhba samruna prótín - meningitis, meningococcal - meningókokka bóluefni - virkt ónæmisaðgerðir gegn innrásarsjúkdómum af völdum neisseria meningitidis serogroup-b stofnanna.

Ultomiris Unió Europea - islandès - EMA (European Medicines Agency)

ultomiris

alexion europe sas - ravulizumab - blóðrauði, ofsakláði - valdar ónæmisbælandi lyf - 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.

Epysqli Unió Europea - islandès - EMA (European Medicines Agency)

epysqli

samsung bioepis nl b.v. - eculizumab - blóðrauði, ofsakláði - Ónæmisbælandi lyf - 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.

Bekemv Unió Europea - islandès - EMA (European Medicines Agency)

bekemv

amgen technology (ireland) uc - eculizumab - blóðrauði, ofsakláði - Ónæmisbælandi lyf - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). sönnunargögn klínískum gagn er sýnt í sjúklinga með haemolysis með klínískum einkenni(s) marks um hár sjúkdómur starfsemi, óháð blóðgjöf sögu (sjá kafla 5.

MenQuadfi Unió Europea - islandès - EMA (European Medicines Agency)

menquadfi

sanofi pasteur - neisseria meningitidis group c polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group a polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group y polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group w-135 polysaccharide conjugated to tetanus toxoid - meningitis, meningococcal - bóluefni - menquadfi is indicated for active immunisation of individuals from the age of 12 months and older against invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, w, and y. the use of this vaccine should be in accordance with available official recommendations.