Euroopan unioni - ruotsi - EMA (European Medicines Agency)

takeda pharma a/s - vedolizumab - colitis, ulcerative; crohn disease - selektiva immunsuppressiva medel - ulcerös colitisentyvio är indicerat för behandling av vuxna patienter med måttlig till svår aktiv ulcerös kolit som har haft ett otillräckligt svar med, förlorade svar på, eller var intoleranta mot antingen konventionell terapi eller en tumor necrosis factor alfa (tnfa-receptorantagonist. crohns diseaseentyvio är indicerat för behandling av vuxna patienter med måttlig till svår aktiv crohns sjukdom som har haft ett otillräckligt svar med, förlorade svar på, eller var intoleranta mot antingen konventionell terapi eller en tumor necrosis factor alfa (tnfa-receptorantagonist. pouchitisentyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

Euroopan unioni - ruotsi - EMA (European Medicines Agency)

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - immunsuppressiva - 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.

Euroopan unioni - ruotsi - EMA (European Medicines Agency)

amgen europe bv - apremilast - arthritis, psoriatic; psoriasis - immunsuppressiva - psoriasisartrit arthritisotezla, ensamt eller i kombination med sjukdomsmodifierande antireumatiska läkemedel (dmard), är indicerat för behandling av aktiv psoriasisartrit (psa) hos vuxna patienter som har haft ett otillräckligt svar eller som har varit intoleranta mot en tidigare dmard behandling. psoriasisotezla är indicerat för behandling av måttlig till svår kronisk plackpsoriasis hos vuxna patienter som inte svarat på eller som har en kontraindikation mot, eller som är intoleranta mot annan systemisk behandling, inklusive ciklosporin, metotrexat eller psoralen och uv-ljus (puva).

Euroopan unioni - ruotsi - EMA (European Medicines Agency)

argenx - efgartigimod alfa - myasthenia gravis - immunsuppressiva - vyvgart is indicated as an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti acetylcholine receptor (achr) antibody positive.

Euroopan unioni - ruotsi - EMA (European Medicines Agency)

sanofi winthrop industrie - teriflunomide - multipel skleros - selektiva immunsuppressiva medel - aubagio is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Euroopan unioni - ruotsi - EMA (European Medicines Agency)

sanofi belgium - alemtuzumab - multipel skleros - selektiva immunsuppressiva medel - lemtrada är indicerat för vuxna patienter med recidiverande remitterande multipel skleros (rrms) med aktiv sjukdom som definieras av kliniska eller avbildningsegenskaper.

Euroopan unioni - ruotsi - EMA (European Medicines Agency)

eli lilly nederland b.v. - baricitinib - artrit, reumatoid - immunsuppressiva - rheumatoid arthritisbaricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). olumiant kan användas som monoterapi eller i kombination med metotrexat. atopic dermatitisolumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy. alopecia areatabaricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5. juvenile idiopathic arthritisbaricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic dmards:- polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [rf+] or negative [rf-], extended oligoarticular),- enthesitis related arthritis, and- juvenile psoriatic arthritis. baricitinib may be used as monotherapy or in combination with methotrexate.

Euroopan unioni - ruotsi - EMA (European Medicines Agency)

merck europe b.v. - cladribine - multipel skleros - immunsuppressiva - behandling av vuxna patienter med högaktiv skovvis förlöpande multipel skleros (ms) som definieras av kliniska eller imaging funktioner.

Euroopan unioni - ruotsi - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuri, paroxysmal - selektiva immunsuppressiva medel - 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.

Euroopan unioni - ruotsi - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - upadacitinib - artrit, reumatoid - immunsuppressiva - rheumatoid arthritisrinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (dmards). rinvoq may be used as monotherapy or in combination with methotrexate. psoriatic arthritisrinvoq is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more dmards. rinvoq may be used as monotherapy or in combination with methotrexate. axial spondyloarthritisnon-radiographic axial spondyloarthritis (nr-axspa)rinvoq is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri), who have responded inadequately to nonsteroidal anti-inflammatory drugs (nsaids). ankylosing spondylitis (as, radiographic axial spondyloarthritis)rinvoq is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. atopic dermatitisrinvoq is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. ulcerative colitisrinvoq is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.  crohn’s diseaserinvoq is indicated for the treatment of adult patients with moderately to severely active crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.