Uni Eropa - Dansk - EMA (European Medicines Agency)

pfizer europe ma eeig - parecoxibnatrium - smerte, postoperative - coxibs, antiinflammatory and antirheumatic products - til kortvarig behandling af postoperativ smerte hos voksne.

Uni Eropa - Dansk - 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 - immunosuppressiva - 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 kan gives som monoterapi i tilfælde af intolerance overfor methotrexat eller når fortsatte behandling med methotrexat er upassende. adalimumab har vist sig at reducere hastigheden af progressionen af ledskader, som målt ved hjælp af x-ray, og til at forbedre den fysiske funktion, når det gives i kombination med methotrexat. 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 kan gives som monoterapi i tilfælde af intolerance overfor methotrexat eller når fortsatte behandling med methotrexat er upassende. adalimumab er ikke blevet undersøgt hos patienter i alderen mindre end 2 år. - 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 har vist sig at reducere hastigheden af progressionen af perifere ledskader, som målt ved hjælp af x-ray i patienter med polyartikulær symmetrisk undertyper af sygdommen og til at forbedre den fysiske funktion. 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.

Uni Eropa - Dansk - EMA (European Medicines Agency)

elanco gmbh - robenacoxib - anti-inflammatory and anti-rheumatic products, non-steroids, coxibs - dogs; cats - katte (tabletter):for treatmentrelief af smerte og inflammation, der er forbundet med akut andor kroniske muskuloskeletale lidelser. for reduktion af moderat smerte og inflammation, der er forbundet med ortopædisk kirurgi. hunde (tabletter):for ttreatment af smerte og inflammation, der er forbundet med kronisk slidgigt. til behandling af smerter og inflammation, der er forbundet med bløddelskirurgi. katte og hunde (opløsning til injektion):for ttreatment af smerte og inflammation, der er forbundet med ortopædisk eller bløddelskirurgi.

Uni Eropa - Dansk - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - adalimumab - hidradenitis suppurativa; psoriasis; uveitis; arthritis, rheumatoid; spondylitis, ankylosing; crohn disease; colitis, ulcerative; arthritis, psoriatic - immunosuppressants, tumor nekrose faktor alfa (tnf-α) - hæmmere

Uni Eropa - Dansk - EMA (European Medicines Agency)

bayer animal health gmbh - iron(iii) ion, toltrazuril - toltrazuril, kombinationer - grise (grise) - for den samtidige forebyggelse af kliniske tegn på coccidiosis (såsom diarré) i neonatale grise på bedrifter med en bekræftet historien af coccidiosis, der er forårsaget af cystoisospora suis, og forebyggelse af jernmangelanæmi.

Uni Eropa - Dansk - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - aripiprazol - skizofreni - psykoleptika - vedligeholdelsesbehandling af skizofreni hos voksne patienter stabiliseret med oral aripiprazol.

Uni Eropa - Dansk - EMA (European Medicines Agency)

ferrer internacional s.a. - loxapin - schizophrenia; bipolar disorder - nervesystem - adasuve er indiceret til hurtig kontrol af mild til moderat agitation hos voksne patienter med skizofreni eller bipolar lidelse. patienter bør regelmæssigt behandles umiddelbart efter kontrol med akutte agitationssymptomer.

Uni Eropa - Dansk - EMA (European Medicines Agency)

glaxo group ltd. - amprenavir - hiv infektioner - antivirale midler til systemisk anvendelse - agenerase, i kombination med andre antiretrovirale midler, er indiceret til behandling af proteasehæmmere (pi), der har oplevet hiv-1-inficerede voksne og børn over 4 år. agenerase kapsler bør normalt administreres med lavdosis ritonavir som en farmakokinetisk forstærker af amprenavir (se afsnit 4. 2 og 4. valget af amprenavir bør baseres på individuel test af viral resistens og behandlingshistorie hos patienter (se afsnit 5. gavn af agenerase forstærket med ritonavir er ikke blevet vist i pi nave patienter (se afsnit 5.

Uni Eropa - Dansk - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - hepatitis b; hepatitis a; immunization - vacciner - ambirix er til brug i ikke-immune personer fra det ene år til og med 15 år for beskyttelse mod hepatitis a og hepatitis b-infektion. beskyttelse mod hepatitis-b-infektioner kan ikke opnås, før efter den anden dosis. derfor:ambirix bør kun anvendes, når der er en relativt lav risiko for hepatitis b infektion under vaccinationen kursus;det anbefales, at ambirix bør administreres i indstillinger, hvor afslutningen af den to-dosis vaccination naturligvis kan være sikker på,.

Uni Eropa - Dansk - EMA (European Medicines Agency)

novartis europharm ltd - ofatumumab - leukæmi, lymfocytisk, kronisk, b-celle - monoklonale antistoffer - tidligere ubehandlet kronisk lymfatisk leukæmi (cll): arzerra i kombination med chlorambucil eller bendamustine er indiceret til behandling af patienter med cll, som ikke har modtaget forudgående behandling, og som ikke er berettiget til fludarabine-baseret terapi. recidiverende cll: arzerra er indiceret i kombination med fludarabine og cyclophosphamid til behandling af voksne patienter med recidiverende cll. refraktær cll: arzerra er indiceret til behandling af cll hos patienter, som er refraktære over for fludarabine og alemtuzumab.