Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

teva b.v., swensweg 5, haarlem, nizozemska - ambrisentan - filmom obložena tableta - 10 mg - urbroj: jedna tableta sadrži 10 mg ambrisentana

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

teva b.v., swensweg 5, haarlem, nizozemska - ambrisentan - filmom obložena tableta - 5 mg - urbroj: jedna tableta sadrži 5 mg ambrisentana

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

aop orphan pharmaceuticals gmbh, leopold-ungar-platz 2, beč, austrija - ambrisentan - filmom obložena tableta - 10 mg - urbroj: svaka filmom obložena tableta sadrži 10 mg ambrisentana

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

aop orphan pharmaceuticals gmbh, leopold-ungar-platz 2, beč, austrija - ambrisentan - filmom obložena tableta - 5 mg - urbroj: svaka filmom obložena tableta sadrži 5 mg ambrisentana

Europska Unija - hrvatski - EMA (European Medicines Agency)

sandoz gmbh - pemetreksed dinatrij hemipentahidrat - carcinoma, non-small-cell lung; mesothelioma - antineoplastična sredstva - maligni mesothelioma плевры Пеметрексед Сандоз u kombinaciji s цисплатином indiciran za liječenje naivne kemoterapije u bolesnika s operirati raka mesothelioma плевры. non-mali rak pluća stanice Пеметрексед Сандоз u kombinaciji s цисплатином indiciran za prva linija terapije u bolesnika s lokalno-uobičajena ili metastatskih немелкоклеточным raka pluća nego drugi uglavnom плоскоклеточной гистологией. Пеметрексед Сандоз prikazan kao monoterapija za liječenje местнораспространенного ili метастатического немелкоклеточного raka pluća, druge, nego pretežno плоскоклеточного гистологии kod pacijenata, bolest kojoj se ne прогрессировало odmah nakon kemoterapije платиносодержащей. Пеметрексед Сандоз prikazan kao monoterapija za drugu liniju liječenja bolesnika s lokalno-uobičajena ili metastatskih немелкоклеточным raka pluća nego drugi uglavnom плоскоклеточной гистологией.

Europska Unija - hrvatski - EMA (European Medicines Agency)

sandoz gmbh - pregabalin - anxiety disorders; epilepsy - antiepileptici sredstva, - epilepsypregabalin Сандоз gmbh prikazan kao dodatna terapija kod osoba s парциальными судорогами sa ili bez sekundarne generalizacije. postati generalizirani anksioznosti disorderpregabalin Сандоз gmbh je indiciran za liječenje generalizirani anksiozni poremećaj (gap) kod odraslih.

Europska Unija - hrvatski - EMA (European Medicines Agency)

janssen-cilag international nv - канаглифлозина, метформина hidroklorid - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - vokanamet prikazan u odraslih osoba u dobi od 18 godina i stariji sa dijabetesom tipa 2 kao dodatak prehrani i fizičke vježbe za poboljšanje glikemijski kontrole kod bolesnika adekvatno ne kontrolira o njihovo maksimalno переносимой doze метформина alonein pacijenata o njihovim maksimalno переносимой doze метформина zajedno s drugim glukoze, smanjuje lijekova, uključujući inzulin, kada oni ne pružaju adekvatnu glikemijski kontrole. kod bolesnika se liječi s kombinacijom канаглифлозина i метформина kao zasebne tabletsfor rezultati istraživanja u odnosu na kombinovanu terapiju, utjecaj na glikemijski kontrolu i kardiovaskularnih događaja, a u ispitivanih skupina, vidi 4. 4, 4. 5 i 5.

Europska Unija - hrvatski - 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

glaxosmithkline trading services limited - albiglutide - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - eperzan je indiciran za liječenje dijabetesa tipa 2 kod odraslih za poboljšanje glikemijski kontrole kao:monotherapywhen dijeta i vježbe sami ne pružaju adekvatnu glikemijski kontrole kod pacijenata kod kojih primjena метформина se smatra da je neprimjereno zbog kontraindikacija ili netolerancije. dodati-na je kombinacija terapiju kombinaciji s drugim сахароснижающих lijekova, uključujući i bazalnog inzulina, kad su, zajedno s prehrane i vježbe ne pružaju adekvatnu glikemijski kontrole (vidi odjeljak 4. 4 i 5. 1 za dostupne podatke o različitim kombinacijama).

Europska Unija - hrvatski - 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.