Euroopan unioni - suomi - EMA (European Medicines Agency)

ucb pharma sa  - sertolitsumabipegoli - niveltulehdus, nivelreuma - immunosuppressantit - nivelreuma arthritiscimzia, yhdessä metotreksaatin (mtx), on tarkoitettu:keskivaikean tai vaikean, aktiivisen nivelreuman (ra) aikuisilla silloin, kun vaste anti-reumaattisiin lääkkeisiin (dmard) mukaan lukien mtx, on ollut riittämätön. cimzia voidaan antaa monoterapiana, jos potilas ei siedä mtx: a tai jos jatkuva mtx-hoito ei inappropriatethe vaikean, aktiivisen ja progressiivisen ra aikuisilla, joita ei aiemmin ole hoidettu mtx: n tai muiden dmard. cimzia on osoitettu hidastavan etenemistä nivelvaurioita mitattuna x-ray ja parantaa fyysistä toimintakykyä, kun sitä annetaan yhdessä mtx: n kanssa. aksiaalinen spondyloartriitti cimzia on tarkoitettu aikuisille potilaille, joilla on vaikea aktiivinen aksiaalinen spondyloartriitti, joka käsittää:selkärankareuman (as)aikuisille, joilla on vaikea aktiivinen selkärankareuma, joilla on ollut riittämätön vaste, tai jotka eivät siedä nsaid-lääkkeet (nsaid). aksiaalinen spondyloartriitti ilman radiologista näyttöä asadults, joilla on vaikea aktiivinen aksiaalinen spon

Euroopan unioni - suomi - EMA (European Medicines Agency)

ucb pharma sa - sertolitsumabipegoli - crohnin tauti - immunosuppressantit - cimzia, in combination with methotrexate (mtx), is indicated for the treatment of moderate to severe, active rheumatoid arthritis (ra) in adult patients when the response to disease-modifying antirheumatic drugs (dmard) including methotrexate, has been inadequate. cimzia voidaan antaa monoterapiana, jos potilas ei siedä metotreksaattia tai metotreksaattihoidon jatkaminen on sopimatonta. cimzia has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate.

Euroopan unioni - suomi - EMA (European Medicines Agency)

elan pharma international ltd. - natalitsumabin - crohnin tauti - immunostimulantit, - hoito keskivaikea tai vaikea aktiivinen crohnin tauti vähentää merkkejä ja oireita, ja induktio ja ylläpito jatkuvan vasteen ja remission potilailla, jotka eivät ole respondoineet huolimatta täydellinen ja asianmukainen hoito kortikosteroideilla ja immunosuppressiivinen; tai jotka eivät siedä tai joilla jokin lääketieteellinen vasta-tällaisia hoitoja.

Euroopan unioni - suomi - EMA (European Medicines Agency)

takeda pharma a/s - vedolizumab - colitis, ulcerative; crohn disease - selektiiviset immunosuppressantit - haavainen colitisentyvio on tarkoitettu aikuisille potilaille, joilla on keskivaikea tai vaikea aktiivinen haavainen koliitti ja joilla on ollut riittämätön vaste kanssa, menetti vastaus, tai eivät sietäneet joko tavanomaiseen hoitoon tai tuumorinekroositekijä-alfa (tnfa) antagonisti. crohnin diseaseentyvio on tarkoitettu aikuisille potilaille, joilla on keskivaikea tai vaikea aktiivinen crohnin tauti, joilla on ollut riittämätön vaste kanssa, menetti vastaus, tai eivät sietäneet joko tavanomaiseen hoitoon tai tuumorinekroositekijä-alfa (tnfa) antagonisti. 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 - suomi - EMA (European Medicines Agency)

glaxosmithkline trading services - mepolizumab - astma - obstruktiivisten hengitystiesairauksien lääkkeet, - severe eosinophilic asthmanucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. chronic rhinosinusitis with nasal polyps (crswnp)nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. eosinophilic granulomatosis with polyangiitis (egpa)nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (egpa). hypereosinophilic syndrome (hes)nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Euroopan unioni - suomi - EMA (European Medicines Agency)

alexion europe sas - ekulitsumabi - hemoglobinuria, paroxysmal - immunosuppressantit - soliris on tarkoitettu aikuisten ja lasten hoitoon:kohtauksittainen yöllinen haemoglobinuria (pnh). todisteita kliininen hyöty on osoitettu potilailla, joilla on hemolyysi kanssa kliinisiä oireita(s) osoittaa korkea taudin aktiivisuus, riippumatta siitä, verensiirtoon historia (ks. kohta 5. epätyypillinen hemolyyttis-ureeminen oireyhtymä (ilmankäsittely-yksiköissä). soliris on tarkoitettu aikuisten hoitoon:tulenkestävät yleistynyt myastenia gravis (gmg) potilailla, jotka ovat anti-asetyylikoliini-reseptorin (achr) vasta-aineen positiivinen (ks. kohta 5. neuromyelitis optica kirjon (nmosd) potilailla, jotka ovat anti-aquaporin-4 (aqp4) vasta-aine positiivinen aaltomaisesti taudinkulku.

Euroopan unioni - suomi - EMA (European Medicines Agency)

amgen technology (ireland) uc - ekulitsumabi - hemoglobinuria, paroxysmal - immunosuppressantit - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). todisteita kliininen hyöty on osoitettu potilailla, joilla on hemolyysi kanssa kliinisiä oireita(s) osoittaa korkea taudin aktiivisuus, riippumatta siitä, verensiirtoon historia (ks. kohta 5.

Euroopan unioni - suomi - EMA (European Medicines Agency)

biogen netherlands b.v. - natalitsumabin - multippeliskleroosi - selektiiviset immunosuppressantit - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 ja 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Euroopan unioni - suomi - EMA (European Medicines Agency)

sandoz gmbh - natalitsumabin - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosuppressantit - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 ja 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.

Euroopan unioni - suomi - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuria, paroxysmal - selektiiviset immunosuppressantit - 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.