Euroopa Liit - eesti - EMA (European Medicines Agency)

glaxosmithkline trading services - mepolizumab - astma - ravimid hingamisteede obstruktiivsete haiguste, - 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.

Euroopa Liit - eesti - EMA (European Medicines Agency)

takeda pharma a/s - vedolizumab - colitis, ulcerative; crohn disease - selektiivsed immunosupressandid - haavandiline colitisentyvio on näidustatud ravi täiskasvanud patsientidel mõõduka kuni raske aktiivse haavandilise koliidi, kes on ebaadekvaatne reaktsioon, kadunud vastuse, või olid sallimatu kas tavalise ravi või tuumori nekroosi faktor α (tnfa) antagonist. crohni diseaseentyvio on näidustatud ravi täiskasvanud patsientidel mõõduka kuni raske aktiivse crohni tõbi, kes on ebaadekvaatne reaktsioon, kadunud vastuse, või olid sallimatu kas tavalise ravi või tuumori nekroosi faktor α (tnfa) antagonist. 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.

Euroopa Liit - eesti - EMA (European Medicines Agency)

samsung bioepis nl b.v. - eculizumab - hemoglobinuuria, paroksüsmaalne - immunosupressandid - epysqli is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history.

Euroopa Liit - eesti - EMA (European Medicines Agency)

alexion europe sas - eculizumab - hemoglobinuuria, paroksüsmaalne - immunosupressandid - soliris on näidatud täiskasvanute ja laste raviks:paroxysmal öise haemoglobinuria (pnh). tõendeid kliinilise kasu on näidanud patsientidel haemolysis kliiniliste sümptomite(s) soovituslik kõrge haiguse aktiivsusega, sõltumata sellest, vereülekande ajalugu (vt lõik 5. ebatüüpiline hemolüütilis-ureemilise sündroomi (ahus). soliris on näidustatud täiskasvanute raviks:tulekindlad generaliseerunud myasthenia gravis (gmg) patsientidel, kes on anti-atsetüülkoliin retseptori (achr) antikeha-positiivsete (vt lõik 5. neuromyelitis optica spectrum disorder (nmosd) patsientidel, kes on anti-aquaporin-4 (aqp4) antikeha-positiivsete koos relapsing haiguse kulg.

Euroopa Liit - eesti - EMA (European Medicines Agency)

amgen technology (ireland) uc - eculizumab - hemoglobinuuria, paroksüsmaalne - immunosupressandid - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). tõendeid kliinilise kasu on näidanud patsientidel haemolysis kliiniliste sümptomite(s) soovituslik kõrge haiguse aktiivsusega, sõltumata sellest, vereülekande ajalugu (vt lõik 5.

Euroopa Liit - eesti - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuuria, paroksüsmaalne - selektiivsed immunosupressandid - 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.

Euroopa Liit - eesti - EMA (European Medicines Agency)

gsk vaccines s.r.l. - välimine membraan, villid alates neisseria meningitidis 'e grupp b (tüvi nz 98/254), rekombinantse neisseria meningitidis' e grupp b fhbp fusion valk, rekombinantse neisseria meningitidis 'e grupp b nada valk, rekombinantse neisseria meningitidis' e grupp b nhba fusion valk - meningiit, meningokokk - meningokoki vaktsiinid - neisseria meningitidis serogrupi-b tüvede põhjustatud invasiivse haiguse aktiivne immuniseerimine.

Euroopa Liit - eesti - EMA (European Medicines Agency)

gsk vaccines s.r.l. - meningokoki rühm a, c, w-135 ja y konjugaatvaktsiin - immunization; meningitis, meningococcal - bakteriaalsed vaktsiinid - vialsmenveo on näidustatud aktiivse immuniseerimise laste (kaks aastat), noorukid ja täiskasvanud ohustab kokkupuude neisseria meningitidis ' e gruppide a, c, w135 ja y, et ennetada invasiivset haigust,. kasutamist see vaktsiin peaks olema kooskõlas ametlike soovitustega.

Euroopa Liit - eesti - EMA (European Medicines Agency)

pfizer europe ma eeig - neisseria meningitidis serogrupp b fhbp (rekombinantne lipiiditud fhbp (faktor h siduv valk)) alamperekond a; neisseria meningitidis serogrupp b fhbp (rekombinantne lipiiditud fhbp (faktori h siduv valk)) alamperekond b - meningiit, meningokokk - bacterial vaccines, meningococcal vaccines - trumenba on näidustatud 10-aastaste ja vanemate inimeste aktiivseks immuniseerimiseks, et vältida neisseria meningitidis'e serogrupi b poolt põhjustatud invasiivset meningokokki. kasutamist see vaktsiin peaks olema kooskõlas ametlike soovitustega.

Euroopa Liit - eesti - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - pegcetacoplan - hemoglobinuuria, paroksüsmaalne - immunosupressandid - aspaveli is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh) who are anaemic after treatment with a c5 inhibitor for at least 3 months.