Unjoni Ewropea - Malti - EMA (European Medicines Agency)

janssen-cilag international nv - ustekinumab - psoriasis; arthritis, psoriatic; crohn disease; colitis, ulcerative - immunosoppressanti - crohn diseasestelara huwa indikat għall-kura ta 'pazjenti adulti b'attiva minn moderata sa gravi marda ta' crohn li kellhom rispons inadegwat b', tilfu r-rispons għal, jew li kienu intolleranti jew terapija konvenzjonali jew tnfa antagonista jew li jkollhom kontra-indikazzjonijiet mediċi għal terapiji bħal dawn. kolite colitisstelara huwa indikat għall-kura ta ' pazjenti adulti b'attiva minn moderata sa gravi kolite bl-ulċeri li kellhom rispons inadegwat b', tilfu r-rispons għal, jew li kienu intolleranti jew terapija konvenzjonali jew bijoloġika jew li jkollhom kontra-indikazzjonijiet mediċi għal terapiji bħal dawn. plakka psoriasisstelara huwa indikat għall-kura moderata għal severa ta ' psorjasi tal-plakka f'adulti li naqsu milli jirrispondu għal, jew li għandhom kontraindikazzjoni għal, jew li huma intolleranti għal terapiji sistemiċi oħrajn inkluż ciclosporin, methotrexate u psoralen ultraviolet-a. pedjatrika tal-plakka psoriasisstelara huwa indikat għall-kura moderata għal severa ta 'psorjasi tal-plakka fit-tfal u pazjenti adolexxenti mill-età ta' 6 snin u akbar, li huma kkontrollati b'mod inadegwat minn, jew li huma intolleranti għal, terapiji jew fototerapiji sistemiċi oħrajn. psorjatika arthritisstelara, waħdu jew f'taħlita ma 'methotrexate, huwa indikat għall-kura ta' artrite psorjatika attiva f'pazjenti adulti meta r-rispons għall-preċedenti mhux bijoloġika li jimmodifikaw il-marda anti-rewmatiċi tad-droga (dmard) it-terapija kienet inadegwata.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - virus tal-influwenza maqsuma, inattivat, li fih antiġen: razza użata bħala a / vietnam / 1194/2004 (h5n1) użata (nibrg-14) - influenza, human; immunization; disease outbreaks - vaċċini - immunizzazzjoni attiva kontra s-sottotip h5n1 tal-virus influwenza a.. din l-indikazzjoni hija bbażata fuq dejta ta 'immunoġeniċità minn individwi b'saħħithom mill-età ta' 18-il sena'l quddiem wara l-amministrazzjoni ta 'żewġ dożi ta' vaċċin ippreparati minn a/vietnam/1194/2004 nibrg-14 (h5n1) (ara sezzjoni 5. vaċċin għal influwenza prepandemika (h5n1) (virjon maqsum, mhux attivat, supplimentat) glaxosmithkline biologicals 3. 75 µg għandu jintuża skond gwida uffiċjali.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - a / indoneżja / 05/2005 (h5n1) bħal razza użata (pr8-ibcdc-rg2) - influenza, human; immunization; disease outbreaks - vaċċini - immunizzazzjoni attiva kontra s-sottotip h5n1 tal-virus ta 'l-influwenza a. din l-indikazzjoni hija bbażata fuq dejta ta 'immunoġeniċità minn individwi b'saħħithom mill-età ta' 18-il sena'l quddiem wara l-amministrazzjoni ta 'żewġ dożi ta' vaċċin ippreparati bl-sottotip h5n1 razez. prepandrix għandu jintuża skond gwida uffiċjali.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; spondylitis, ankylosing; crohn disease; colitis, ulcerative; hidradenitis suppurativa; psoriasis; arthritis, rheumatoid - immunosoppressanti - jekk jogħġbok irreferi għas-sezzjoni 4. 1 tas-sommarju tal-karatteristiċi tal-prodott fid-dokument ta 'informazzjoni tal-prodott.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - adalimumab - hidradenitis suppurativa; arthritis, psoriatic; psoriasis; crohn disease; arthritis, juvenile rheumatoid; uveitis; arthritis, rheumatoid; colitis, ulcerative; spondylitis, ankylosing - immunosoppressanti - jekk jogħġbok irreferi għas-sezzjoni 4. 1 tas-sommarju tal-karatteristiċi tal-prodott fid-dokument ta 'informazzjoni tal-prodott.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

biomarin international limited - pegvaliase - phenylketonurias - prodotti oħra alimentari u metaboliżmu - palynziq huwa indikat għall-kura ta 'pazjenti b'phenylketonuria (pku) fl-età ta'16-il sena u ikbar li jkunu adegwati ta' phenylalanine fid-demm tal-kontroll (fenilalanina fid-demm livelli akbar minn 600 mikromol/l) minkejja qabel l-immaniġġjar bl-għażliet ta ' trattament disponibbli.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

roche registration gmbh - satralizumab - neuromyelitis optica - immunosoppressanti - satralizumab (enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

ucb pharma s.a.   - bimekizumab - psorajiżi - immunosoppressanti - 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

glaxosmithkline trading services limited - sotrovimab - covid-19 virus infection - sera immuni u immunoglobulini, - xevudy is indicated for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (covid-19) who do not require oxygen supplementation and who are at increased risk of progressing to severe covid-19.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - majloma multipla - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.