Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

sandoz gmbh - rituksimabas - lymphoma, non-hodgkin; arthritis, rheumatoid; microscopic polyangiitis; wegener granulomatosis - antinavikiniai vaistai - riximyo is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)riximyo is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy. riximyo maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. riximyo monotherapy is indicated for treatment of adult patients with stage iii-iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. riximyo is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. riximyo in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll). chronic lymphocytic leukaemia (cll)riximyo in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. tik ribotą duomenų apie veiksmingumą ir saugumą pacientams, anksčiau gydomi monokloniniai antikūnai, įskaitant rituximab ar pacientams, ugniai atsparios į ankstesnį rituximab plius chemoterapija. Žr. skyrių 5. 1, jei norite gauti daugiau informacijos. rheumatoid arthritisriximyo in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (dmard) including one or more tumour necrosis factor (tnf) inhibitor therapies. rituximab buvo įrodyta, kad sumažinti greitį progresavimą, bendrą žalą, vertinant pagal x-ray ir gerinti fizinę funkciją, skiriant kartu su metotreksatu. granulomatosis with polyangiitis and microscopic polyangiitisriximyo, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa). riximyo, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa. pemphigus vulgarisriximyo is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinurija, paroksizminis - selektyvūs imunosupresantai - 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.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - daugybinė mieloma - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituksimabas - lymphoma, non-hodgkin; arthritis, rheumatoid; wegener granulomatosis; leukemia, lymphocytic, chronic, b-cell; microscopic polyangiitis - antinavikiniai vaistai - truxima yra nurodyta suaugusiems šių nuorodų:ne hodžkino limfoma (nhl)truxima nurodomas gydymo anksčiau negydytų pacientų su iii etapas iv follicular limfoma kartu su chemoterapija. truxima palaikomojo gydymo fluorouracilu gydyti follicular limfoma sergantiems pacientams reaguoti į indukcijos terapija. truxima monotherapy skiriamas pacientų, sergančių iii etapas iv follicular limfoma, kurie yra chemo atsparios arba yra jų antrasis arba vėlesni recidyvas po chemoterapijos. truxima skiriamas pacientams, sergantiems cd20 teigiamas difuzinė didelių b ląstelių ne hodžkino limfoma kartu su pjaustyti (ciklofosfamidas, doxorubicin, vincristine, prednizoloną) chemoterapija. lėtine limfocitine leukemija (lll)truxima kartu su chemoterapija yra nurodyta gydomi pacientai, sergantys anksčiau negydytų ir atsinaujino/ugniai atsparūs lll. yra tik nedaug duomenų apie pacientų, anksčiau gydytų monokloniniais antikūnais, įskaitant truxima, veiksmingumą ir saugumą arba pacientų, kurie atsparūs ankstesniems truxima ir chemoterapijai. reumatoidinis arthritistruxima kartu su metotreksatu fluorouracilu gydyti suaugusiems pacientams, sergantiems sunkia aktyvus reumatoidinis artritas, kurie buvo nepakankamas atsakas ar nepakantumas kitų ligų pakeisti stabdžių priešreumatiniai vaistai (dmard), įskaitant vieną ar daugiau naviko nekrozės faktorius (tnf) inhibitorių terapija. truxima buvo įrodyta, kad sumažinti greitį progresavimą, bendrą žalą, vertinant pagal x ray ir gerinti fizinę funkciją, skiriant kartu su metotreksatu. sepsinė su polyangiitis ir mikroskopinių polyangiitistruxima, kartu su gliukokortikoidai, yra nurodyta gydyti suaugusius pacientus, sergančius sunkiu, aktyviu sepsinė su polyangiitis (wegener ' s) (vps) ir mikroskopinių polyangiitis (mpa). pemphigus vulgaristruxima skiriamas pacientams, sergantiems vidutinio sunkumo ar sunkia pemphigus vulgaris (pv).

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

sfl pharmaceuticals deutschland gmbh - nyxthracis - anthrax - imuninės serumai ir imunoglobulinai, - obiltoxaximab sfl is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to bacillus anthracis (see section 5. obiltoxaximab sfl is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

merck sharp & dohme b.v. - bezlotoxumab - enterokolitas, pseudomembraninis - imuninės serumai ir imunoglobulinai, - zinplava skiriama clostridium difficile infekcijos (cdi) pasikartojimo prevencijai suaugusiesiems, kuriems yra didelė cdi pasikartojimo rizika.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

merck europe b.v. - avelumabas - neuroendokrininiai navikai - kiti antinavikiniai vaistai agentai, monokloniniai antikūnai, - bavencio yra monoterapija, skirta suaugusiems pacientams, sergantiems metastazavusia merkelio ląstelių karcinoma (mcc). bavencio kartu su axitinib yra nurodyta pirmos eilės gydymas suaugę pacientai, sergantys progresavusia inkstų ląstelių karcinoma (rbt). bavencio is indicated as monotherapy for the first‑line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc) who are progression-free following platinum‑based chemotherapy.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - avatrombopag maleate - trombocitopenija - antihemoraginiai - doptelet fluorouracilu gydyti sunkia trombocitopenija suaugusiųjų pacientams, sergantiems lėtine kepenų liga, kas yra planuojama atlikti invazinės procedūros. doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (itp) in adult patients who are refractory to other treatments (e. kortikosteroidai, imunoglobulinai).

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

astrazeneca ab - nirsevimab - imuninės serumai ir imunoglobulinai, - beyfortus is indicated for the prevention of respiratory syncytial virus (rsv) lower respiratory tract disease in neonates and infants during their first rsv season. beyfortus should be used in accordance with official recommendations.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

pfizer europe ma eeig - moroktokogas alfa - hemofilija a - antihemoraginiai - kraujavimo gydymas ir profilaktika pacientams, sergantiems hemofilija a (įgimtu viii faktoriaus trūkumu). refacto af tinka naudoti suaugusiems ir vaikams visose amžiaus grupėse, įskaitant naujagimiams. refacto af nėra von-willebrand faktorius, ir todėl nėra nurodyta von-willebrand liga.