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.

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)

samsung bioepis nl b.v. - ranibitsumabi - wet macular degeneration; macular edema; diabetic retinopathy; myopia, degenerative - silmätautien - byooviz is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of proliferative diabetic retinopathy (pdr)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)the treatment of visual impairment due to choroidal neovascularisation (cnv).

Euroopan unioni - suomi - EMA (European Medicines Agency)

roche registration ltd. - daklitsumabia - graft rejection; kidney transplantation - immunosuppressantit - zenapax on tarkoitettu akuutin hylkimisreaktion de novo allogenic munuaisten transplantaation ennaltaehkäisyyn ja käytetään samanaikaisesti immunosuppressiivinen hoito, kuten siklosporiinin ja kortikosteroidien potilailla, jotka heitä, erittäin ovat ole rokotettu.

Euroopan unioni - suomi - EMA (European Medicines Agency)

biogen idec ltd - daklitsumabia - multippeliskleroosi - immunosuppressantit - zinbryta on tarkoitettu aikuispotilaille multippeliskleroottisten relapsoivien muotojen (rms) hoitoon..

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)

novartis europharm limited - ranibitsumabi - wet macular degeneration; macular edema; diabetes complications; myopia, degenerative; choroidal neovascularization - silmätautien - lucentis on tarkoitettu aikuisille:hoito neovaskulaarisen (kostean) ikään liittyvä silmänpohjan rappeuma (amd)hoito näkövamman vuoksi suonikalvon uudissuonittumisesta (cnv)hoito näkövamman vuoksi diabeettinen makulaturvotus (dme)hoidossa näön huonontuminen makulaarisen ödeeman takia, toissijainen verkkokalvon laskimotukos (branch rvo tai keski-rvo).

Euroopan unioni - suomi - EMA (European Medicines Agency)

stada arzneimittel ag - ranibitsumabi - wet macular degeneration; macular edema; diabetic retinopathy; diabetes complications - silmätautien - ximluci is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of proliferative diabetic retinopathy (pdr)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)the treatment of visual impairment due to choroidal neovascularisation (cnv).

Euroopan unioni - suomi - EMA (European Medicines Agency)

midas pharma gmbh - ranibitsumabi - wet macular degeneration; macular edema; diabetic retinopathy; diabetes complications - silmätautien - ranivisio is indicated in adults for:• the treatment of neovascular (wet) age-related macular degeneration (amd)• the treatment of visual impairment due to diabetic macular oedema (dme)• the treatment of proliferative diabetic retinopathy (pdr)• the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)• the treatment of visual impairment due to choroidal neovascularisation (cnv).