Evrópusambandið - íslenska - EMA (European Medicines Agency)

mylan s.a.s. - dócetaxel - head and neck neoplasms; carcinoma, non-small-cell lung; adenocarcinoma; prostatic neoplasms; breast neoplasms - Æxlishemjandi lyf - meðferð brjóstakrabbamein, sérstaka mynd af lungnakrabbamein (ekki lítið-klefi lungnakrabbamein), krabbamein í blöðruhálskirtli, krabbamein í maga, eða höfðinu og hálsinn krabbamein.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - anakinra - arthritis, rheumatoid; covid-19 virus infection - Ónæmisbælandi lyf - rheumatoid arthritis (ra)kineret is indicated in adults for the treatment of the signs and symptoms of ra in combination with methotrexate, with an inadequate response to methotrexate alone. covid-19kineret is indicated for the treatment of coronavirus disease 2019 (covid-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (supar) ≥ 6 ng/ml. periodic fever syndromeskineret is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above:cryopyrin-associated periodic syndromes (caps)kineret is indicated for the treatment of caps, including:neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca)muckle-wells syndrome (mws)familial cold autoinflammatory syndrome (fcas)familial mediterranean fever (fmf)kineret is indicated for the treatment of familial mediterranean fever (fmf). kineret ætti að gefa í ásamt colchicine, ef viðeigandi. still’s diseasekineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of still’s disease, including systemic juvenile idiopathic arthritis (sjia) and adult-onset still’s disease (aosd), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (nsaids) or glucocorticoids. kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (dmards).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; colitis, ulcerative; arthritis, juvenile rheumatoid; spondylitis, ankylosing; psoriasis; crohn disease; arthritis, rheumatoid - Ónæmisbælandi lyf - 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. , meðferð alvarlega, virk og framsækið liðagigt í fullorðnir ekki áður meðhöndluð með stendur. ,  amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. amgevita dregur úr hraða framvindu sameiginlega skaða sem mæla með x-ray og bæta líkamlega virka, þegar gefið ásamt stendur. 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 getur verið gefið eitt og sér í málið óþol stendur eða þegar áframhaldandi meðferð með stendur er óviðeigandi (fyrir virkni í sér sjá kafla 5. adalimumab hefur ekki verið rannsakað í sjúklinga á aldrinum minna en 2 ár. 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 dregur úr framvindu af útlimum sameiginlega skaða sem mæla með x-ray í sjúklinga með fjölliða samhverfu flokkar sjúkdómsins (sjá kafla 5. 1) og bæta líkamlega virka. 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 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.

Evrópusambandið - íslenska - 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 - Ónæmisbælandi lyf - 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 getur verið gefið eitt og sér í málið óþol stendur eða þegar áframhaldandi meðferð með stendur er óviðeigandi. adalimumab hefur verið sýnt fram á að draga úr framvindu sameiginlega skaða sem mæla með x-ray og til að bæta líkamlega virka, þegar gefið ásamt stendur. 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 getur verið gefið eitt og sér í málið óþol stendur eða þegar áframhaldandi meðferð með stendur er óviðeigandi. adalimumab hefur ekki verið rannsakað í sjúklinga á aldrinum minna en 2 ár. - 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. adalimumab hefur verið sýnt fram á að draga úr framvindu af útlimum sameiginlega skaða sem mæla með x-ray í sjúklinga með fjölliða samhverfu flokkar sjúkdómsins og til að bæta líkamlega virka. 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - adalimumab - arthritis, rheumatoid; arthritis, psoriatic; psoriasis; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; crohn disease; arthritis, juvenile rheumatoid - Ónæmisbælandi lyf - rheumatoid arthritisyuflyma 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. yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. adalimumab hefur verið sýnt fram á að draga úr framvindu sameiginlega skaða sem mæla með x-ray og til að bæta líkamlega virka, þegar gefið ásamt stendur. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritisyuflyma 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). yuflyma 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. adalimumab hefur ekki verið rannsakað í sjúklinga á aldrinum minna en 2 ár. enthesitis-related arthritisyuflyma 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)yuflyma 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 asyuflyma 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). psoriatic arthritisyuflyma 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. adalimumab hefur verið sýnt fram á að draga úr framvindu af útlimum sameiginlega skaða sem mæla með x-ray í sjúklinga með fjölliða samhverfu flokkar sjúkdómsins (sjá kafla 5. 1) og til að bæta líkamlega virka. psoriasisyuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasisyuflyma 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)yuflyma 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 5. crohn’s diseaseyuflyma 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 diseaseyuflyma 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 colitisyuflyma 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. paediatric ulcerative colitisyuflyma 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. uveitisyuflyma 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 uveitisyuflyma 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

takeda pharma a/s - brentuximab vedotin - lymphoma, non-hodgkin; hodgkin disease - Æxlishemjandi lyf - hodgkin lymphomaadcetris is indicated for adult patients with previously untreated cd30+ stage iv hodgkin lymphoma (hl) in combination with doxorubicin, vinblastine and dacarbazine (avd). adcetris is indicated for the treatment of adult patients with cd30+ hl at increased risk of relapse or progression following autologous stem cell transplant (asct). adcetris is indicated for the treatment of adult patients with relapsed or refractory cd30+ hodgkin lymphoma (hl):following asct, orfollowing at least two prior therapies when asct or multi-agent chemotherapy is not a treatment option. systemic anaplastic large cell lymphomaadcetris in combination with cyclophosphamide, doxorubicin and prednisone (chp) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (salcl). adcetris is indicated for the treatment of adult patients with relapsed or refractory salcl. cutaneous t cell lymphomaadcetris is indicated for the treatment of adult patients with cd30+ cutaneous t cell lymphoma (ctcl) after at least 1 prior systemic therapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

takeda manufacturing austria ag - octocog alfa - hemophilia a - antihemorrhagics - meðferð og fyrirbyggjandi blæðingar hjá sjúklingum með dreyrasýki a (meðfæddan þáttur viii-skortur). advate inniheldur ekki von willebrand þáttur í ly árangri magni og er því ekki fram í von willebrand sjúkdómur.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - dócetaxel - stomach neoplasms; adenoma; breast neoplasms; carcinoma, non-small-cell lung; prostatic neoplasms - Æxlishemjandi lyf - brjóst cancerdocetaxel ásamt doxórúbicíns og cýklófosfamíði er ætlað til viðbótar meðferð sjúklinga með nýtilegt hnút-jákvæð brjóstakrabbamein. docetaxel ásamt doxórúbicíns er ætlað fyrir sjúklinga með staðnum háþróaður eða brjóstakrabbamein sem hafa ekki áður fengið frumudrepandi meðferð fyrir þessu ástandi. docetaxel sér er ætlað fyrir sjúklinga með staðnum háþróaður eða brjóstakrabbamein eftir bilun frumudrepandi meðferð. fyrri krabbameinslyfjameðferð ætti að hafa innihaldið anthracycline eða alkýlerandi efni. docetaxel ásamt trastuzumab er ætlað fyrir meðferð sjúklinga með brjóstakrabbamein sem æxli yfir tjá her2 og sem áður hefur ekki fengið lyfjameðferð fyrir sjúklingum sjúkdómur. docetaxel ásamt capecitabine er ætlað fyrir sjúklinga með staðnum háþróaður eða brjóstakrabbamein eftir bilun frumudrepandi lyfjameðferð. fyrri meðferð ætti að hafa innihaldið anthracyclin. ekki lítið klefi lunga cancerdocetaxel er ætlað fyrir sjúklinga með staðnum háþróaður eða sjúklingum ekki lítið klefi lungnakrabbamein eftir bilun af áður en lyfjameðferð. docetaxel ásamt cisplatíni er ætlað fyrir sjúklinga með unresectable, á staðnum háþróaður eða sjúklingum ekki lítið klefi lungnakrabba, í sjúklingar sem hafa ekki áður fengið lyfjameðferð í þessu ástandi. blöðruhálskirtli cancerdocetaxel ásamt prednisone eða prednisólóni er ætlað fyrir sjúklinga með hormón svarar sjúklingum krabbamein í blöðruhálskirtli. maga adenocarcinomadocetaxel ásamt cisplatíni og 5-fluorouracil er ætlað fyrir sjúklinga með sjúklingum með krabbamein í maga, þar á meðal krabbamein í maga junction, sem ekki hafa fengið áður en lyfjameðferð fyrir sjúklingum sjúkdómur. höfðinu og hálsinn cancerdocetaxel ásamt cisplatíni og 5-fluorouracil er ætlað til að framkalla meðferð sjúklinga með staðnum háþróaður æxli klefi krabbamein í höfðinu og hálsinn.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

takeda pharma a/s - vedolizumab - colitis, ulcerative; crohn disease - valdar ónæmisbælandi lyf - sárum colitisentyvio er ætlað fyrir meðferð fullorðinn sjúklinga með nokkuð að alvarlega virka sárum niðurgang sem hafa verið ófullnægjandi að bregðast við, misst að bregðast við, eða voru óþol að annaðhvort hefðbundin meðferð eða æxli drep þáttur alfa (tnfa) hemla. crohn-diseaseentyvio er ætlað fyrir meðferð fullorðinn sjúklinga með nokkuð að alvarlega virka crohn-sjúkdóm sem hafa verið ófullnægjandi að bregðast við, misst að bregðast við, eða voru óþol að annaðhvort hefðbundin meðferð eða æxli drep þáttur alfa (tnfa) hemla. 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

eco animal health europe limited - týlvalósín - antiinfectives fyrir almenn nota, sýklalyf fyrir almenn nota makrólíða - pheasants; chicken; turkeys; pigs - pigstreatment og methaphylaxis svín enzootic lungnabólgu;meðferð svín fjölgunar enteropathy (ileitis);meðferð og methaphylaxis svín blóðkreppusótt. chickenstreatment og methaphylaxis um sjúkdóma í öndunarfærum tengslum við r gallisepticum í hænur. pheasantstreatment um sjúkdóma í öndunarfærum tengslum við r gallisepticum. turkeystreatment um sjúkdóma í öndunarfærum tengslum við tylvalosin viðkvæm stofnum ornithobacterium rhinotracheale í kalkúna.