Euroopan unioni - suomi - EMA (European Medicines Agency)

horizon therapeutics ireland dac - inebilizumab - neuromyelitis optica - immunosuppressantit - uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (nmosd) who are anti-aquaporin 4 immunoglobulin g (aqp4-igg) seropositive (see section 5.

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)

theratechnologies europe limited - ibalizumab - hiv-infektiot - antiviraalit systeemiseen käyttöön - trogarzo, yhdessä muiden antiretroviraalisten(s), on tarkoitettu hoitoon aikuisille tartunnan kanssa useita resistenttejä hiv-1-infektio, joille se ei muuten ole mahdollista rakentaa tukahduttava antiviraalinen hoito.

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.

Suomi - suomi - Fimea (Suomen lääkevirasto)

baxter oy - cyclophosphamide monohydrate - injektiokuiva-aine, liuosta varten - syklofosfamidi

Suomi - suomi - Fimea (Suomen lääkevirasto)

baxter oy - cyclophosphamide monohydrate - tabletti, päällystetty - 50 mg - syklofosfamidi