Union européenne - croate - EMA (European Medicines Agency)

takeda manufacturing austria ag - ljudski normalni imunoglobulin (ivig) - purpura, thrombocytopenic, idiopathic; bone marrow transplantation; immunologic deficiency syndromes; guillain-barre syndrome; mucocutaneous lymph node syndrome - imuni serumi i homologna, - hormonske terapije kod odraslih i djece i adolescenata (0-18 godina): sindromi primarne imunodeficijencije povrede антителообразования;hypogammaglobulinaemia i rekurentne bakterijske infekcije u bolesnika s kroničnim лимфолейкозом, u kojima su preventivni antibiotici nisu pomogli;hypogammaglobulinaemia i рецидивирующих bakterijskih infekcija kod plato faza-nekoliko bolesnika, koji nisu uspjeli odgovoriti na пневмококковой cijepljenja;hypogammaglobulinaemia u bolesnika nakon аллогенной transplantacije hematopoetski organi-transplantacija matičnih stanica (ТГСК);urođena aids-a i рецидивирующих bakterijske infekcije. Иммуномодуляция kod odraslih, i kod djece i adolescenata (0-18 godina): primarni imunološki trombocitopenija (ihs), u bolesnika s visokim rizikom od krvarenja ili prije operacije za podešavanje broja trombocita u krvi;sindrom Гийена barre;bolest kawasaki;мультифокальная motorna neuropatija (ММН).

Union européenne - croate - EMA (European Medicines Agency)

janssen-cilag international nv - bosentan (as monohydrate) - hypertension, pulmonary; scleroderma, systemic - drugi antihipertenzivi sredstva - liječenje plućne arterijske hipertenzije (pah) za poboljšanje sposobnosti vježbanja i simptoma u bolesnika s funkcionalnom klasom svjetske zdravstvene organizacije (who) iii. učinkovitost je prikazan u:primarna (idiopatska i nasljedna) fuj;fuj sekundarne склеродермии bez značajnog интерстициальные bolesti pluća;lag, povezana sa urođenim sistem-na-plućna шунтов i eisenmenger fiziologije. neka poboljšanja su također je prikazano u bolesnika s lag, koji funkcionalna klasa ii. stayveer također je istakao smanjenje broja novih digitalne ulkusa kod pacijenata sa sistemske склеродермией i stalnom digitalni-peptičkog ulkusa.

Union européenne - croate - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; colitis, ulcerative; arthritis, juvenile rheumatoid; spondylitis, ankylosing; psoriasis; crohn disease; arthritis, rheumatoid - imunosupresivi - rheumatoid arthritis  amgevita in combination with methotrexate, is indicated for: , the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. tretman teških, aktivnog i uznapredovalog reumatoidnog artritisa kod odraslih, ne ranije liječenih metotreksat. ,  amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. amgevita smanjuje brzinu progresije oštećenja zglobova kao što se mjeri x-ray i poboljšava fizičke funkcije, imenovanje u kombinaciji s metotreksatom. juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis amgevita in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). amgevita može biti dano kao monoterapija u slučaju netolerancije метотрексата ili pri stalnom liječenju s metotreksat je nepraktično (na učinkovitost u monoterapija vidi odjeljak 5. Адалимумаб ne ima dugu povijest u bolesnika u dobi od manje od 2 godine. enthesitis-related arthritis amgevita is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5. axial spondyloarthritis ankylosing spondylitis (as) amgevita is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of as amgevita is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs. psoriatic arthritis amgevita is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. amgevita smanjuje brzinu progresije periferne lezije zgloba, mjereno pomoću x-zraka u bolesnika s полиартикулярным mogućnost simetrične podtipovi bolesti (vidi odjeljak 5. 1) i poboljšava fizičke značajke. psoriasis amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasis amgevita is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs) amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 i 5. crohn’s disease amgevita is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's disease amgevita is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. ulcerative colitis amgevita is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitis amgevita is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. paediatric uveitis amgevita is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Union européenne - croate - EMA (European Medicines Agency)

leadiant gmbh - Хенодезоксихолевая kiselina - xanthomatosis, cerebrotendinous; metabolism, inborn errors - bile i jetrena terapija - chenodeoxycholic kiselina je indiciran za liječenje urođene pogreške primarne žučne kiseline sinteze zbog nedostatka sterol 27 hidroksilaze (predstavlja kao cerebrotendinous xanthomatosis (ctx)) u dojenčadi, djece i adolescenata u dobi od 1 mjeseca do 18 godina i odrasle osobe.

Union européenne - croate - EMA (European Medicines Agency)

stada arzneimittel ag - epoetin zeta - anemia; blood transfusion, autologous; cancer; kidney failure, chronic - antianemijski pripravci - liječenje simptomatske anemije, povezane s kroničnom bubrežnom insuficijencijom (crf) kod odraslih i pedijatrijski patientstreatment anemija povezana s hronične bubrežne insuficijencije kod odraslih i pedijatrijski pacijenti na гемодиализе i kod odraslih pacijenata na dijalizi перитонеальном. liječenje teška anemija bubreg podrijetla u pratnji kliničkim simptomima kod odraslih bolesnika s zatajenja bubrega, ne nalaze na dijalizi. liječenje anemije i smanjenje potrebe transfuzije krvi kod odraslih pacijenata koji primaju kemoterapiju za uglednih tumora maligni limfom ili multiple myeloma, kao i na rizik трансфузии оцениваемым opće stanje pacijenta (e. stanje kardiovaskularnog sustava, već postojeće anemije u početku kemoterapije). silapo može se koristiti za povećanje prinosa autologne krvi kod pacijenata u program predonation . njegova upotreba u ovom pokazatelj mora biti uravnotežena protiv najavljenog rizik od komplikacija тромбоэмболических . liječenje bi trebalo biti dano samo za bolesnike s umjerenom anemičan (ne железодефицитная), ako je krv štednje procedure nisu dostupne ili nedostatna za planirane velike planska operacija zahtijeva velike količine krvi (4 i više jedinica krvi za žene ili 5 ili više jedinica za muškarce). silapo drugačije za nepušače, pate od nedostatka željeza u tijelu odrasle osobe do velikih элективной ortopedskoj kirurgiji, imaju visok rizik od komplikacija transfuzija krvi kako bi se umanjio utjecaj аллогенных гемотрансфузий . primjena mora biti ograničen za bolesnike s umjerenom anemičan (e. raspon izmjerena koncentracija hemoglobina od 10 do 13 g/dl), koji nemaju na raspolaganju program loznih predonation i očekuje se da će razumni gubitak krvi (od 900 do 1 800 ml). silapo može se koristiti za povećanje koncentracije hemoglobina u simptomatske anemija (koncentracija hemoglobina ≤10 g/dl) u odraslih bolesnika s niskim ili middleware-1 rizikom od primarnih миелодиспластических sindromi (mds), koje imaju nisku razinu proteina eritropoetin (.

Union européenne - croate - EMA (European Medicines Agency)

samsung bioepis nl b.v. - adalimumab - spondylitis, ankylosing; arthritis, rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; hidradenitis suppurativa; arthritis - imunosupresivi - reumatoidni arthritisimraldi u kombinaciji s metotreksatom prikazana za:liječenje umjereni do teški, aktivan reumatoidni artritis kod odraslih pacijenata, kada odgovor na bolest-модифицирующих противоревматических lijekova, uključujući i metotreksat, bio je neadekvatno. tretman teških, aktivnog i uznapredovalog reumatoidnog artritisa kod odraslih, ne ranije liječenih metotreksat. imraldi može biti dano kao monoterapija u slučaju netolerancije метотрексата ili pri stalnom liječenju s metotreksat je nepraktično. Адалимумаб, kao što je prikazano, kako bi se smanjila brzina progresije oštećenja zglobova kao što se mjeri x-ray i poboljšati fizičku funkciju, prilikom raspoređivanja u kombinaciji s metotreksatom. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritisimraldi in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). imraldi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. Адалимумаб ne ima dugu povijest u bolesnika u dobi od manje od 2 godine. enthesitis-related arthritisimraldi is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5. axial spondyloarthritisankylosing spondylitis (as)imraldi is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of asimraldi is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and / or mri, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (nsaids). psorijatični arthritisimraldi indiciran za liječenje aktivnog i uznapredovalog psorijatični artritis kod odraslih, kad odgovor na prethodni заболевани-дорабатывая anti-reumatskih napitke terapija je bila neadekvatna.. adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5. 1) i poboljšati tjelesne funkcije. psoriasisimraldi indiciran za liječenje umjerene do teške kronične plak psorijaze kod odraslih pacijenata koji su kandidati za sistemske terapije. vrtić plak psoriasisimraldi indiciran za liječenje teških oblika kroničnog бляшечного psorijaze u djece i adolescenata od 4-ih godina, koji su imali neadekvatan odgovor ili neprikladne kandidate za lokalne liječenje i phototherapies. hidradenitis suppurativa (hs)imraldi is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 i 5. kruna diseaseimraldi indiciran za liječenje reumatoidnog crohnove bolesti, kod odraslih pacijenata koji se nisu odazvali, unatoč potpuni i odgovarajući tečaj terapija sa kortikosteroidima i/ili imunosupresivima, ili koji ne podnose ili imaju medicinske kontraindikacije za takvu terapiju. paediatric crohn's diseaseimraldi is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or haveulcerative colitisimraldi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. paediatric ulcerative colitisimraldi is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitisimraldi is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whomcorticosteroid treatment is inappropriate. paediatric uveitisimraldi is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Union européenne - croate - EMA (European Medicines Agency)

amgen technology (ireland) uc - bevacizumab - carcinoma, renal cell; peritoneal neoplasms; ovarian neoplasms; breast neoplasms; carcinoma, non-small-cell lung; fallopian tube neoplasms - antineoplastična sredstva - mvasi u kombinaciji s kemoterapijom na bazi fluoropirimidina je indiciran za liječenje odraslih bolesnika s metastaznim karcinomom debelog crijeva ili rektuma. mvasi u kombinaciji s paklitaksel je indiciran za prva linija terapije kod odraslih pacijenata s metastaze raka dojke . za daljnje informacije o stanju čovjeka epidermalnog faktora rasta receptora 2 (her2), molimo pogledajte odjeljak 5. mvasi, osim платин-na temelju kemoterapije, dizajniran je za prvu liniju terapije odraslih pacijenata s нерезектабельными-najčešće metastaze ili recidivom немелкоклеточным raka pluća nego drugi uglavnom плоскоклеточной гистологией. mvasi in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. mvasi, u kombinaciji s карбоплатин i paklitaksel je indiciran za prednje linije terapiju odraslih pacijenata s uznapredovalom (međunarodna federacija za ginekologiju i opstetriciju (figo) fazama ІІІБ, МНКР i iv) epitela jajnika, masterbatch cijevi ili primarni rak перитонеальный . mvasi, u kombinaciji s карбоплатином i гемцитабином ili u kombinaciji s карбоплатином i паклитакселом, indiciran za liječenje odraslih bolesnika s prvi relaps платиночувствительный epitela jajnika, jajovoda ili primarni перитонеальным raka, koji nisu primili ranije terapiju бевацизумабом ili drugim inhibitori Фрэс ili vegf receptore-meta agenata. mvasi in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor-targeted agents. mvasi, u kombinaciji s паклитакселом i цисплатином ili паклитакселом i топотеканом kod pacijenata koji ne mogu dobiti платиновую terapiju, indiciran za liječenje odraslih bolesnika s uporni, relaps ili метастатической карциномой grlića maternice.

Union européenne - croate - EMA (European Medicines Agency)

sandoz gmbh - adalimumab - arthritis, rheumatoid; arthritis, psoriatic; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; arthritis, juvenile rheumatoid; crohn disease; skin diseases, papulosquamous - imunosupresivi - rheumatoid arthritishyrimoz in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. hyrimoz može biti dano kao monoterapija u slučaju netolerancije метотрексата ili pri stalnom liječenju s metotreksat je nepraktično. Адалимумаб, kao što je prikazano, kako bi se smanjila brzina progresije oštećenja zglobova kao što se mjeri x-ray i poboljšati fizičku funkciju, prilikom raspoređivanja u kombinaciji s metotreksatom. juvenile idiopathic arthritis- polyarticular juvenile idiopathic arthritishyrimoz in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). hyrimoz može biti dano kao monoterapija u slučaju netolerancije метотрексата ili pri stalnom liječenju s metotreksat je nepraktično. Адалимумаб ne ima dugu povijest u bolesnika u dobi od manje od 2 godine. - enthesitis-related arthritishyrimoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. axial spondyloarthritis- ankylosing spondylitis (as)hyrimoz is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. - axial spondyloarthritis without radiographic evidence of ashyrimoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and / or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. psoriatic arthritishyrimoz is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Адалимумаб, kao što je prikazano, kako bi se smanjila brzina progresije periferne lezije zgloba, mjereno pomoću x-zraka u bolesnika s полиартикулярным mogućnost simetrične podtipovi bolesti i poboljšati tjelesne funkcije. psoriasishyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasishyrimoz is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs)hyrimoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy. crohn’s diseasehyrimoz is indicated for treatment of moderately to severely active crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's diseasehyrimoz is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies.  paediatric ulcerative colitishyrimoz is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. ulcerative colitishyrimoz is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitishyrimoz is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. paediatric uveitishyrimoz is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Union européenne - croate - EMA (European Medicines Agency)

pharmaand gmbh - rucaparib camsylate - neoplazme jajnika - antineoplastična sredstva - rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. rubraca prikazan kao monoterapija za liječenje odraslih bolesnika s платиночувствительный recidiva kvalitetan epitela jajnika, jajovoda ili primarni перитонеальным raka, koji se u odgovor (potpuno ili djelomično) na bazi platine kemoterapije.

Union européenne - croate - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - avatrombopag maleate - trombocitopenija - antihemorrhagics - doptelet naznačeno za liječenje teških тромбоцитопении kod odraslih pacijenata s kroničnom bolešću jetre, koji planiraju proći postupak инвазивную. doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (itp) in adult patients who are refractory to other treatments (e. kortikosteroidi, imunoglobulini).